Standard Operating Procedure (SOP) / Guideline for Preparation and Handling of Regulatory Audit (FDA Inspection) in Pharmaceutical Drug Manufacturing Plant. Handling of Regulatory Audit (FDA Inspection) 1.0   PURPOSE The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for Handling the Regulatory Audit. 2.0   SCOPE This SOP shall be used as such […]

Standard Operating Procedure (SOP) for Local Area Network (IT Network / LAN) qualification procedure, Protocol, and related documentation. Procedure for qualification of IT network equipment’s for the fulfillment of availability of hardware as per requirement, guidance for re-qualification and to provide the procedure for numbering of network equipment. Qualification of Local Area Network (LAN) 1.0  […]

Standard Operating Procedure (SOP) for Handling of Out of Specification (OOS) Test Result in Microbiological Analysis. OOS results include all test results that fall outside of the specification or acceptance criteria established in drug applications, drug master files, official compendia, or by the manufacturer. Handling of (Microbiology) Out-of-Specification (OOS) Results 1.0   Purpose The objective of […]

Standard Operating Procedure & Guideline for preparation and control of Validation Master Plan (VMP) for Instrument, Equipment, Facility in the pharmaceutical drug manufacturing plant. SOP for Validation Master Plan (VMP) 1.0   PURPOSE The purpose of this SOP is to lay down the procedure of preparation and control of the Validation Master Plan (VMP). 2.0   SCOPE […]

Standard Operating Procedure for preparation and handling of different types of Technical Agreement. Agreement undertook by written and legally binding on two parties (Contract giver and contract acceptor). Technical Agreement 1.0   PURPOSE: The purpose of this SOP (Standard Operating Procedure) is to describe the procedure for the preparation and handling of all technical agreement (s). […]

Standard Operating Procedure (SOP) for IT Infrastructure Qualification of Computer System used in cGxP environment at the pharmaceutical company. Computer System – IT Infrastructure Qualification 1.0   Objective  This Procedure defines the procedure for qualifying and maintaining the qualified status (Qualification) of Computerized Systems (CS) Infrastructure to ensure that Computerized Systems that use that infrastructure and […]

A placebo batch of a product is processed as per regular formulation of that product except for the active ingredient or A dosage form that is identical to the drug product except that the drug substance is absent or replaced by an inert ingredient or a mixture of the drug product excipients quantitatively equivalent to […]

Audit Checklist (s) for different department/section/area like – Engineering / maintenance, HVAC Area, Purified water system, Quality Control, Warehouse, Granulation, Compression, Coating, Packing / Packaging, Personal and administration (HR), Microbiology and Quality Assurance area etc. to check the effectiveness  of the implemented systems. Checklist for Routine Inspection /Audit 1.0   Audit checklist for Engineering area Sr. […]

Standard Operating Procedure (SOP) for Handling of Interim/On-line Rejection during manufacturing and packing of drug substances or drug product. Handling of Interim/On-line Rejection 1.0   Purpose : To define procedure for Handling of Interim/On-line Rejections during manufacturing and packing of drug substances. 2.0   Scope : This SOP is applicable for Handling of Interim/On-line Rejections during manufacturing […]

Standard Operating Procedure (SOP) for Gram’s Staining of Microorganisms. Gram stain or Gram staining, also called Gram’s method, is a method of staining used to distinguish and classify bacterial species into two large groups: gram-positive bacteria and gram-negative bacteria. The name comes from the Danish bacteriologist Hans Christian Gram, who developed the technique Procedure for […]

Standard Operating Procedure (SOP) for Handling, Investigation, Classification and Reporting of Incident by Environmental,  Health and Safety (EHS) department in pharmaceuticals. Incident Investigation, Classification and Reporting (EHS) 1.0   PURPOSE: To laydown a procedure to describe the incident, its classification, the requirement of investigation and its reporting procedure by Environment, Health and Safety Department (EHS). The […]

Protocol and Procedure for Installation Qualification of Programmable Logic Controller (PLC) connected with Manufacturing Equipment. Installation Qualification of Programmable Logic Controller (PLC) 1.0   Objective : The objective of this protocol to provide the written guidelines for execution of the installation qualification of Programmable Logic Controller (PLC) based HMI System for ________ Define the installation qualification […]

 Standard Operating Procedure (SOP) and Format for Instrument, Equipment usage logbook used for day to day activity and recording of usage details in pharmaceuticals. Equipment Usage Logbook 1.0   PURPOSE: This purpose of this SOP is to define the procedure for issuance, handling, making entries and review of   “Instrument/ Equipment usage logbook”. 2.0   SCOPE: This procedure […]

Standard Operating Procedure (SOP) and Protocol for Calibration of Laboratory Glassware (Class A)  like- Volumetric flask, Pipette calibration, Burette calibration used in Quality Control Laboratory for analysis purpose. Glassware Calibration Procedure 1.0   Purpose: The purpose of this SOP is to describe the procedure for calibration of laboratory glassware. 2.0   Scope: This SOP is applicable for […]

Standard Operating Procedure (SOP) for Preparation, Handling and Hold Time Study of Reference Solution. In analytical chemistry, a standard solution is a solution containing a precisely known concentration of an element or a substance. A known weight of solute is dissolved to make a specific volume. It is prepared using a standard substance, such as […]

Analytical Method Transfer (also called ‘Method Transfer’): A documented process that qualifies a laboratory (i.e., the Receiving Unit) to use an analytical test procedure that originated in another laboratory (i.e., the Transferring Unit), thus ensuring that the Receiving Unit has the procedural knowledge and ability to perform the transferred analytical procedure as intended Analytical Method […]

Standard Operating Procedure (SOP) for operation & calibration of digital microscope. A microscope consists of a compound magnifying system in which the observer looks at the first (primary) image with a lens that produces an enlarged secondary (virtual) image. Microscope – Operation & Calibration 1.0   Purpose: To lay down the procedure for operation and calibration […]

Guideline (SOP) for risk based Environmental Monitoring (EM) in Non Sterile drug manufacturing facility. Regulatory standards for non-sterile product manufacture and environmental control have not been consistently established, however, EU GMP requires inhalants to be manufactured in an ISO 8 environment and compendia, such as USP <1111> Microbiological Examination of Nonsterile Products. Procedure for Environmental […]

This Guideline applies to routine Environmental Monitoring (EM) activities in classified manufacturing areas for viable and non-viable particulates, aseptic area personnel gown and glove samples, and for utility systems supplying those areas, such as compressed air, process gases, clean steam and water systems ENVIRONMENTAL MONITORING (EM) PROGRAM 1.0   OBJECTIVE : This Global Quality Standard (GQS) […]

Standard Operating Procedure (SOP) for Handling of User Requirement Specification (URS) for a computerized system or Instrument / Equipment. User Requirement Specification (URS) is a document that informs the software vendor / software on the users expectations from the software User Requirement Specification (URS) 1.0   PURPOSE: The purpose of this SOP is to establish procedure […]

Standard Operating Procedure (SOP) and Guideline for Validation of Analytical Method (AMV). The objective of validation of an analytical Method (AMV) is to demonstrate that it is suitable for its intended purpose. Procedure for Analytical Method Validation (AMV) 1.0   Objective : To lay down procedure for validation of Analytical Method (AMV) to be followed in […]

Standard Operating Procedure (SOP & Guideline) for swab test analysis. Swab test analysis is being done to avoid chances of cross contamination from one product to another. By this method we assure that the machine / equipment is free from active ingredients of previous product. Procedure for Swab Test Analysis 1.0   Objective : To lay […]

Standard Operating Procedure (SOP) for sampling of packaging materials (i.e. Aluminum Foil Printed & Plain / Aluminum Foil Forming / PVC / PVDC / HDPE Bottle / Glass Bottle/ Cap Child Resistant /Cap Non Child Resistant / PP Cap / Catch Box / Catron / Label etc. Procedure for Sampling of Packaging Materials 1.0   Objective […]

Standard Operating Procedure (SOP) for cleaning and operation of Alexander werk GmbH (Germany) make Roller compactor machine. Roller Compactor Machine 1.0   Purpose : The purpose of this SOP is to lay down the cleaning and operation procedure for Roller Compactor. 2.0   Scope : This SOP  is applicable for cleaning and operation of Roller compactor WP […]

Standard Operating Procedure (SOP) and Guideline for Preparation and Standardization of Volumetric Solution(s) used during analysis of Raw material and drug product at pharmaceutical quality control department. Preparation & Standardization of Volumetric Solution(s) Advertisement 1.0   Objective : The purpose of this SOP is to describe a procedure for Preparation & Standardization of Volumetric solution. 2.0  […]

Standard Operating Procedure (SOP) for procedure for Validation / Qualification of Steam Sterilizer used in microbiology laboratories. Validation of Steam Sterilizer 1.0   Purpose: To lay down the procedure for Validation of Steam Sterilizers. 2.0   Scope: This Standard Operating Procedure is applicable at microbiology section of Quality Control department. 3.0   References & Annexures: References: Health Technical […]

Standard Operating Procedure (SOP) for Operation, Cleaning and Calibration of Newtronic make BOD Incubator used in microbiology department for analytical activity. BOD Incubator 1.0   Purpose: To lay down the procedure for Operating, Calibration and Cleaning of BOD Incubators Model No.: NEC134 RTSSI. 2.0   Scope: This Standard Operating Procedure is applicable at Microbiology section of Quality […]

Performance Qualification (PQ) Protocol for Sterilizing and Depyrogenating Tunnel is to verify that the equipment produces the desired output. Performance qualification (PQ) of the equipment is planned after the successful completion of the installation and operational qualification. PQ Protocol – Sterilizing and Depyrogenating Tunnel Sr. No. ITEM DESCRIPTION PAGE NO. 1.0 PROTOCOLAPPROVAL 2.0 OVERVIEW: 2.1 […]

Protocol For Qualification / Requalification of Air Handling Unit / System (AHU). This protocol describes the procedure for different tests methods, acceptance criteria, requalification criteria and documentation to be used for requalification of Air handling unit (AHU) serving to manufacturing area of Drug Product. Qualification of Air handling unit (AHU) Sr No. Item Description Page […]

Standard Operating Procedure (SOP) for the working in network of Chromatographic system using Chromeleon software. Management of Chromatographic System Control and Privileges Policy in Chromeleon software. Handling Procedure of Chromeleon Software 1.0   Objective : The purpose of this SOP is to describe a procedure for the working in network of Chromatographic system using Chromeleon software. […]

Standard Operating Procedure (SOP) for Handling of Primary and Secondary Standards used in Quality Control Laboratory for Analytical Purpose. Handling Procedure for Primary and Secondary Standards 1.0   PURPOSE : The purpose of this SOP is to define the procedure for handling of primary and secondary standards used in analysis. 2.0   SCOPE : This procedure is […]

Standard Operating Procedure (SOP) for Operation and Maintenance of Purified Water Loop system used in pharmaceutical drug manufacturing plant. Purified Water Loop System 1.0   PURPOSE: The purpose of this SOP is to define the procedure for operation and maintenance of Purified water loop system. 2.0   SCOPE: This procedure is applicable for Purified water loop installed […]

Standard Operating Procedure (SOP) for Operation, Cleaning and Qualification of Biosafety Cabinet (ESCO) used to storage of Microbiological Media, Cultures and other material used in laboratory. Biosafety Cabinet (ESCO) 1.0   PURPOSE: To lay down the procedure for operation, cleaning and qualification of Biosafety Cabinet (ESCO). 2.0   SCOPE: This Standard Operating Procedure is applicable at Microbiology […]

Standard Operating Procedure (SOP) & Guideline for Continued Process Verification. It is the exercise for assuring that during routine production the process remains in a state of control.  Advertisement Procedure for Continued Process Verification 1.0   Purpose : To define procedure for the Continued Process Verification. 2.0   Scope :  This guideline is applicable for Continued Process […]

Standard Operating Procedure (SOP) and Guideline for handling the breakdown maintenance of Instrument, Equipment, System and Utilities in pharmaceutical Drug Manufacturing Plant. Breakdown Maintenance System 1.0   Purpose : To define procedure for Breakdown Maintenance System. 2.0   Scope :    This guideline is applicable to maintenance of all Equipment or Machine. 3.0   Reference, Attachments and Annexures : […]

Standard Operating Procedure (SOP) and Guideline for Sampling, Analysis of Blend Uniformity (BU) samples, and Stratified In-process dosage unit Sampling. Blend Uniformity (BU) – Sampling & Analysis 1.0   Purpose : To define the procedure for the Blend uniformity analysis and Stratified In-process dosage unit Sampling. 2.0   Scope : This guideline is applicable for Blend uniformity […]

Standard Operating Procedure (SOP) for Microbial Culture Suspension Preparation, Cell Enumeration, Use, Storage, and Destruction in the microbiology department. Microbial Culture Suspension & Cell Enumeration 1.0   Purpose: The purpose of this SOP is to describe the procedure for the preparation of culture suspension and the enumeration of cells. 2.0   Scope: This  SOP is applicable to Bacterial […]

Standard Operating Procedure (SOP) and Guideline for Handling of Punches and Dies used in the compression machine for tablet compression. This SOP covers the procedure for procurement, Issuance, Handling, Cleaning, Inspection and Rejection of punches and dies. SOP for Punches & Dies 1.0   Purpose: To define the procedure for procurement, Issuance, Handling, Cleaning, Inspection, and […]

Standard Operating Procedure (SOP) and Guideline for the Receipt, Storage, Preparation, Growth Promotion Test, use, and Disposal of microbiological media. Microbiological Media Guideline 1.0   Purpose: To define the procedure for the receipt, storage, preparation, growth promotion test, use, and disposal of Microbiological Media used during microbiological analysis. 2.0   Scope: This guideline is applicable to microbiological […]

Standard Operating Procedure (SOP) & Guideline for manufacturing, packaging (bulk and packed), labeling, testing, release, shipping, and destruction of Investigational Medicinal Product (IMPD Clinical Trial). Investigational Medicinal Product (IMPD Clinical Trial) 1.0   PURPOSE: To describe the procedure for the manufacturing, packaging, labeling, release, shipping, and destruction of Investigational Medicinal Product (IMPD). 2.0   SCOPE: This procedure […]

Standard Operating Procedure (SOP) and Guideline for Receipt, Qualification, Usage, Regeneration, and Discardation of HPLC/UPLC column. Procedure for Handling of HPLC/UPLC Column 1.0   Purpose : To define the procedure for the Receipt, Qualification, Usage, Regeneration, and Discardation of HPLC/UPLC column. 2.0   Scope : This guideline is applicable to all HPLC/UPLC columns received at the quality […]

Standard Operating Procedure (SOP) & Guideline to define the role and responsibility of Quality Assurance in Laboratory (as Lab QA) in different activities. Role & Responsibility of Quality Assurance in Laboratory (Lab QA) 1.0   PURPOSE: The purpose of this SOP is to define the role and responsibility of Quality Assurance in the Laboratory (as Lab […]

Standard Operating Procedure (SOP) and Guideline for Operation of Documentum software for issuance, approval, rejections, and retrieval of forms and formats. Procedure for Operation of Documentum Software 1.0   Purpose: To define the procedure for the operation of Documentum software. 2.0   Scope: This guideline is applicable to Documentum software for issuance, approval, rejections, and retrieval of […]

Standard Operating Procedure (SOP) and Protocol for Operation and Calibration of Micropipette (fixed volume or variable volume micropipettes). Operation and Calibration Procedure of Micropipette 1.0   Purpose: To lay down the procedure for Operation and calibration of the Micropipette. 2.0   Scope: This Standard Operating Procedure is applicable at microbiology section of Quality Control department for operation […]

Standard Operating Procedure (SOP) for Operation, Calibration, and Maintenance of Malvern Make Particle Size Analyzer (Mastersizer 2000 & 3000). SOP for Particle Size Analyzer (Malvern) 1.0   PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to describe the Operation, Calibration, Maintenance of the Particle Size Analyzer (Malvern). 2.0   SCOPE: This SOP is applicable to […]

Standard Operating Procedure (SOP) and Guideline to describe the process and requirements to file a Field Alert Report (FAR) to the U.S. Food and Drug Administration (FDA) for products distributed/marketed in the United States. SOP for Field Alert Report Submission 1.0   OBJECTIVE This SOP/Guideline describes the process and requirements to file a Field Alert Report […]

Growth promotion test (GPT): Also referred to as fertility or nutritive properties test, which is performed on the media used during different tests like sterility test, microbial limit test, preservative efficacy test to demonstrate that it is capable of supporting the growth of micro-organisms SOP for Growth Promotion Test (USP) 1.0   PURPOSE: To lay down […]

Standard Operating Procedure (SOP) for Handling of Returned Goods Pharmaceutical Product/Material. These returned goods (materials) either fails to meet the established Specification or returned on the basis of breakage / damaged packaging. Handling of Return Goods (Drug Product / Material) 1.0   PURPOSE: The purpose of this SOP is to define the procedure for handling, redressing, […]

Standard Operating Procedure (SOP) for Operation, Cleaning, and Calibration of Micro & Semi-Micro Analytical Balance used for weighing WS & Impurities in QC and Research Laboratories. Procedure for Micro Balance Operation and Calibration 1.0   PURPOSE: To describe the procedure for operation, calibration, and performance check of the Micro Balance. 2.0   SCOPE: The SOP applies to […]

This protocol/SOP is designed to establish the scientific evidence and demonstrate the efficacy of disinfectants and sanitizing agents against various microorganisms by “Use Dilution or Concentration Method” and “Surface Challenge Test.” Efficacy Evaluation of Disinfectants & Sanitizing Agents Table of Content – Disinfectants Efficacy Protocol: Sr. No Topics 1.0 Protocol Approval 2.0 Purpose 3.0 Scope […]

Standard Operating Procedure (SOP) for the sampling/collection of trial, in-process, Finished product, micro, hold time, validation, control, and stability sample. SOP for Drug Product Sampling 1.0   PURPOSE: To define the procedure for the sampling of trial, in-process, finish, micro, hold time, validation, control, and stability sample. 2.0   SCOPE: This SOP is applicable for the collection […]

Standard Operating Procedure (SOP) & guideline for the Handling of Outliers or aberrant or Out of Specification test result in Near Infrared (NIR) Analysis. Handling of Outliers in Near Infrared (NIR) Analysis 1.0   Purpose: The purpose of this SOP is to describe the procedure for the Handling of Outliers in Near Infrared (NIR) Analysis. 2.0  […]

Standard Operating Procedure (SOP) and Guideline for preparation of Equipment / System Qualification  (URS, IQ, OQ, PQ, FAT, SAT, etc.) documents, execution of Qualification activities, Review and Compilation of data, Assessment and Interpretation of Qualification & validation activity results. Equipment and System Qualification 1.0   Purpose : To lay down the procedure for preparation of Qualification […]

Standard Operating Procedure (SOP) for cleaning of the water storage tank (Fire Hydrant, Soft Water, RO water) in the pharmaceutical drug manufacturing plant. Cleaning of the Water Storage Tank 1.0   PURPOSE: The purpose of this SOP is to define the procedure for cleaning the water storage tank. 2.0   SCOPE: This procedure is applicable for all […]

Standard Operating Procedure (SOP) for the Calculation of  Yield and finalize the Limit at the different stages of drug product processing/manufacturing. This SOP is also applicable for Investigation of out of limit yield obtained during processing. Calculation of  Yield and finalize the Limit 1.0   OBJECTIVE : To lay down a procedure for fixation of yield […]

Standard Operating Procedure (SOP) to lay down a procedure to describe the operation and maintenance of the fire System. It also provides a guide to achieve successful fire fighting operations inside the factory premises Procedure for Operation and Maintenance of Fire System 1.0   PURPOSE: To lay down a procedure to describe the operation and maintenance […]

Standard Operating Procedure (SOP) for Contract Laboratory Agreement and analytical testing. It covers all the processes of sample sending, sample analysis, and report review of the contract testing laboratory. Contract Laboratory Agreement and Testing 1.0   PURPOSE: To provide guidance to audit and approval of contract analytical testing laboratory as per cGMP requirement. To provide guidance […]

The investigation related to quality-related events that occur from cGxPs approved specifications, and/or procedures including but not limited to Protocols, Master Batch Records (MBR), Batch Packaging Records (BPR), breakdowns, facilities, storage, distribution, manufacturing, testing, packaging, warehouse and distribution of drug products. Guideline on Investigation Tools 1.0   PURPOSE: This Standard Operating Procedure (SOP) defines the requirements […]

Standard Operating Procedure (SOP) for Handling of Raw material and Packing Material returned from different sections of the manufacturing/production department to stores/warehouse. Handling of Returned Raw and Packing Material  1.0   Purpose: To define the procedure for handling of Raw Materials and Packaging Material Returned from the production department.  2.0   Scope – SOP for Returned Material: […]

Standard Operating Procedure (SOP) and Guideline for Good Warehousing Practices for Raw Material and Packing Materials. The storage of materials in the specified areas according to the classification i.e. poison. Corrosive, Flammable, etc. Good Warehousing Practices 1.0   Purpose: The warehousing of Raw materials/packing material is an important aspect for the following reasons: Proper Identification The […]

Standard Operating Procedure (SOP) for cleaning of Pre-filters, Microvee filters, and cartridge filter of the equipment ( AHU, FDV, Autocoaters, FBD,  RLAF, LAF, and Dust Collector ) installed in the Pharmaceutical Plant. Procedure for Filter Cleaning 1.0   PURPOSE: The purpose of this SOP is to define the procedure for cleaning Prefilters, Microvee filters, and cartridge […]

Standard Operating Procedure (SOP) and Guideline for preparation, approval, and revision of Site Master File (SMF). The Site Master File (SMF) Document shall contain specific information about the quality management policies, activities of the site, the production and/or quality control, pharmaceutical manufacturing operations, and any closely integrated operations at adjacent and nearby buildings. Guideline for […]

Standard Operating Procedure (SOP) for Training of Contractual Workers in pharma, A contract worker does not become a regular addition to the staff, hired for a specific job, perform under the close monitoring/supervision company staff. Training of Contractual Worker 1.0   PURPOSE: The purpose of this SOP is to define the procedure of training for CW […]

Standard Operating Procedure (SOP) to define the detailed procedure regarding Pest & Rodent Control in Pharmaceuticals drug manufacturing plant. Pest & Rodent Control Procedure 1.0   Purpose: The purpose of this SOP is to lay down the procedure for Pest & Rodent Control treatment in the plant. 2.0   Scope: This procedure is applicable for controlling the […]

Aseptic technique is a critical requirement for collecting and testing sterile and non-sterile samples in order to avoid contamination that could provide incorrect test results. SOP for Aseptic Technique 1.0   OBJECTIVE : The objective of this Standard Operating Procedure (SOP) is to define proper aseptic a technique during microbiological sampling and testing to avoid contamination […]

Standard Operating Procedure (SOP) for Housekeeping of the different areas of Factory Premises at pharmaceutical drug manufacturing plants. Good Housekeeping Practices in Pharma Plant 1.0   PURPOSE: The purpose of this SOP (Standard Operating Procedure) is to lay down the procedure for housekeeping of the factory premises. 2.0   SCOPE – HOUSEKEEPING PRACTICES: This SOP is applicable […]

The EHS policy is a guiding principle used to set direction in an organization. It is used for a course of action to guide and influence decisions. It should be used as a guide to decision making under a given set of circumstances within the framework of objectives, goals, and management philosophies as determined by […]

Standard Operating Procedure SOP for Good Laboratory Practices (GLP) in line with the Schedule L1 requirement of the drug and cosmetic act. Good Laboratory Practices (GLP) embodies a set of principles that provides a framework within which laboratory studies (activities) are planned, performed, monitored, recorded, reported, and archived. Good Laboratory Practices (GLP) 1.0   Purpose: The […]

Safety at Workplace related to the working environment at a company and encompasses all factors that impact the safety and health of employees. This can include environmental hazards, unsafe working conditions or processes, drug and alcohol abuse, and workplace violence. Safety at Workplace – SOP for Safety Management 1.0   PURPOSE: This procedure will provide guidance […]

Standard Operating Procedure (SOP) for Handling and Investigation of Extraneous Peak(s) in Chromatography Analysis. What are the Extraneous Peaks: A peak response in the chromatogram that is not readily attributable as a characteristic of the injection profiles of the blank, mobile phase, diluting solvent, placebo, standard, or sample solutions. By definition, extraneous means introduced from […]

Standard Operating Procedure (SOP) for the handling of rejected raw materials and packing materials which are rejected due to the Non-conformance of Quality Standards, Online rejection, or Improper storage. Handling of Rejected Materials (Raw Material & Packing Material) 1.0   Purpose: To define the procedure for the handling of rejected materials (Raw Material & Packing Material). […]

Standard Operating Procedure (SOP) for reconciliation of packing materials and bulk at the end of the packing of each batch of Drug Product SOP for Reconciliation of Packing Materials 1.0   PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to describe the detailed procedure for the reconciliation of packing materials and bulk at the […]

Standard Operating Procedure (SOP) to define the procedure for operation and regeneration of the Purified Water Plant (Mixed bed unit). SOP for Purified Water Plant 1.0   PURPOSE: To define the procedure for operation and regeneration of Purified Water Plant (Mixed bed unit). 2.0   SCOPE: This procedure is applicable to the operation and regeneration of the […]

Standard Operating Procedure (SO) for Operation and Calibration of Auto Titrator (Potentiometer) for its utility in carrying out different types of Titration SOP for Auto Titrator (Potentiometer) 1.0   PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for the Operation and Calibration of the Auto Titrator for its utility in […]

Residual solvent in pharmaceuticals is defined here as organic volatile chemicals that are used or produced in the manufacture of drug substances or excipients, or in the preparation of drug products. LIMIT OF RESIDUAL SOLVENTS IN DRUG PRODUCT 1.0   Purpose: The purpose of this Standard Operating Procedure (SOP) is to describe the limit of residual […]

Standard Operating System (SOP) issuance, controlling, and management of different Protocols and its numbering System in pharmaceuticals for different activities. A protocol is a written statement to conduct the validation process along with the procedure, test method, equipment handling, specifications, acceptance criteria, report, and approval. Protocol Numbering System 1.0   PURPOSE: The purpose of this SOP […]

Standard Operating Procedure (SOP) for the recording of Specimen Signatures of Employees and contract personnel. Specimen Signature is a copy of your name written by yourself that an organization keeps so that they can be sure that your name on a document was also written by you. SOP for Recording of Specimen Signature 1.0   PURPOSE: […]

Standard Operating Procedure (SOP) for Operation, Cleaning, and Performance Check for Refrigerator used to store the  Microbiology Culture, Spores, Media, etc in the Microbiology Lab. Refrigerator Used in Microbiology Lab 1.0   Purpose: The purpose of this SOP is to describe the Operation, Cleaning, and Performance check procedure of Refrigerator used for the storage of microbiology […]

This SOP provides guidance to evaluate the potential of the proposed new product for cross-contamination and assessment of the containment approach required to manufacture the new product at Manufacturing and Packaging Facilities. For existing products, Quality Risk Management for Cross-contamination shall be performed as per SOP “Prevention of cross-contamination, Mix up and Microbial Contamination” for […]

Calibration Procedure / SOP for Ultra Performance Liquid Chromatography (UPLC) System. UPLC can be regarded as a new direction for liquid chromatography. UPLC refers to ultra-performance liquid chromatography, which improves in three areas: “speed, resolution, and sensitivity”. This Procedure is applicable for Waters Make UPLC – Aquity, UPLC – H Class, Thermo Make U-HPLC Systems, […]

Standard Operating Procedure (SOP) for operation and maintenance of the Oven used to determine the Loss on Drying (LOD) in the Quality Control Department. Loss on drying (LOD) is the loss of weight expressed as percentage w/w resulting from water and volatile matter of any kind that can be driven off under specified condition. SOP […]

Standard Operating Procedure (SOP) for Operation, Cleaning, and Calibration of Flame Photometer used in inorganic chemical analysis to determine the concentration of certain metal ions, among them sodium, potassium, lithium, and calcium. SOP for Flame Photometer 1.0   PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to describe the operation and calibration of the […]

Standard Operating Procedure (SOP) and Detailed Risk Assessment approach for Prevention of Cross Contamination, Mix-ups, and Microbial Contamination. Prevention of Cross Contamination, Mix-Ups & Microbial Contamination 1.0   PURPOSE: The purpose of this procedure is to ensure that the manufacture of all finished drug products and Active Pharmaceutical Ingredients is accompanied by risk-based approaches and controls […]

Standard Operating Procedure (SOP) for Operation and Cleaning of Electromagnetic Sieve Shaker which is used to determine the particle size of pharmaceutical starting material (API and Excipients). SOP for Electromagnetic Sieve Shaker 1.0   Purpose: The purpose of this SOP ( Standard Operating Procedure) is to describe the operation of Electromagnetic sieve shaker. 2.0   Scope: This […]

Standard Operating Procedure (SOP) cum Guideline for Good Documentation Practices for cGxP documents (Electronic and Handwritten) Pharmaceutical Drug Manufacturing Plants. Guideline for Good Documentation Practices 1.0   PURPOSE: This Standard Operating Procedure (SOP) defines the requirements for the compliant, consistent, and accurate completion of Good Documentation Practices. 2.0   SCOPE: This standard applies to cGxP documents (electronic […]

Standard Operating Procedure (SOP) for Operation and Cleaning of COBB TESTER used for the analysis of packing/packaging material in the Quality Control Laboratory. SOP for Cobb Tester 1.0   Purpose : The purpose of this SOP is to describe the procedure for the operation and cleaning of Cobb tester. 2.0   Scope : This SOP is applicable […]

Standard Operating Procedure (SOP) and Format/Protocol for Calibration of HPLC system (Parameters are Pressure test, Drift and Noise, Flow Rate Accuracy, Autosampler by carryover check,  detector by linearity measurement, etc.) Calibration of HPLC System 1.0   PURPOSE: The purpose of this SOP is to describe the Procedure for Calibration of high-performance liquid Chromatography in Quality Control. […]

Standard Operating Procedure (SOP) for Operation and Calibration of Friability Test Apparatus used to perform the analysis of the Friability Test in solid doses form (Tablet). Procedure For Operation and Calibration of Friabilator 1.0   Purpose: The purpose of this SOP is to describe the procedure for operation and calibration of the Friability apparatus. 2.0   Scope […]

Standard Operating Procedure (SOP) and Policy/Program for Calibration of Instrument, Equipment, and Measuring Device used to measurement, monitoring, and controlling of operation and process in different departments at the Pharmaceutical Drug Manufacturing Plant. Calibration is a set of operations that establish under specified conditions, the relationship between values indicated by a measuring instrument or measuring […]

Standard Operating Procedure (SOP) for Handling of Out of Specification (OOS) test results in packaging (packing) material so as to ensure that all such test results are properly investigated and closed before taking a decision to release/reject the item, and corrective actions are taken to avoid recurrence. Handling of Out of Specification (OOS) in Packaging […]

Standard Operating Procedure (SOP) for Process Standardization and Validation be carried for the new products and existing products at the formulation plant. SOP for Process Standardization and Validation 1.0   Purpose: To lay down a procedure for process standardization and process validation study. 2.0   Scope – Process Standardization and Validation: The SOP is applicable to process […]

Standard Operating Procedure (SOP) for approval and release of Finished Product Batch for moving from the manufacturing site to supply chain/distributors or C&F warehouses.  Procedure for Finished Product Batch Release 1.0   PURPOSE: To lay down the procedure for approval and release of the finished product batch. 2.0   SCOPE: This Standard Operating Procedure is applicable for […]

Standard Operating Procedure (SOP) for Cleaning Validation (CV) in the pharmaceutical drug manufacturing plants. Cleaning Validation (CV) is the documented evidence that an approved cleaning procedure is consistent in reducing product residue and removal of cleaning agents (if any), bioburden, flavor (if any), color (if any) from equipment and accessories within the acceptance level. Procedure […]

Standard Operating Procedure (SOP) for Handling Power Failure situations in different areas like Production, Quality Contro, Microbiology, Utility, Stores, etc at the pharmaceutical drug manufacturing plant. Procedure for Handling of Power Failure in Pharma 1.0   Purpose: To lay down a procedure for handling power failure situations. 2.0   Scope: This procedure is applicable to handling power […]

Standard Operating Procedure (SOP) for Media Fill Validation in Sterile facility.  A “media fill” (sometimes known as a “process simulation”) is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium in place of the drug solution. The microbiological growth medium is used in place of the drug solution during media fills […]

Standard Operating Procedure (SOP) and Protocol for Microbiologist Qualification (validation) to establish and assure that Microbiologist is capable of performing Microbiological testing in Microbiology Department. Microbiologist Qualification 1.0   PURPOSE : The purpose of this Standard Operating Procedure (SOP) is to lay down the Procedure for Microbiologist Qualification (validation) to establish and assure that Microbiologist is […]

Chromatography is a laboratory technique for the separation of a mixture. The mixture is dissolved in a fluid called the mobile phase, which carries it through a structure holding another material called the stationary phase. The various constituents of the mixture travel at different speeds, causing them to separate. GOOD CHROMATOGRAPHY PRACTICES 1.0   PURPOSE : The […]

Protocol for Qualification and Re-Qualification or Validation of Heating Ventilation and Air Conditioning (HVAC) system for Clean Room. HVAC System Qualification Protocol (Validation) Table of Content – HVAC System Qualification Protocol    S.No. Table of Contents Page 1.0 Protocol Approval 2.0 History Sheet 3.0 Objective 4.0 Scope 5.0 Responsibilities 6.0 Equipment Description 6.1 System Specification […]

Standard Operating System (SOP) for Qualification and Re-Qualification of Heating Ventilation and Air Conditioning (HVAC) system for Clean Room. Qualification of HVAC System 1.0   PURPOSE The Purpose of this SOP is to lay down the Procedure for qualification/Requalification, of Heating Ventilation and Air Conditioning System (HVAC). 2.0   SCOPE This SOP is applicable for the qualification/requalification […]

Standard Operating Procedure (SOP) for the handling of Pharmacopoeial Change at Drug Product Manufacturing Location. Handling when Pharmacopoeial changes in monographs and appearance of the new monographs for drug substances, excipients, drug products and updation or addition or deletion of general chapters.  Handling of Pharmacopoeial Change at Drug Manufacturing Location 1.0   Purpose: To define the […]

Standard Operating Procedure (SOP) for Operation and Calibration of Dissolution Test Apparatus (Make- Electrolab) used to measure the drug release of Oral Solid Doses in pharmaceuticals. This SOP Contains following Topics – A) Operating Procedure for Electrolab Dissolution Apparatus, Model : TDT-08L 0, TDT-14L, and similar models. B) Calibration Procedure and Formats for Dissolution Apparatus […]

Standard Operating Procedure (SOP) for Operation and Calibration of Melting Point Apparatus used for analysis / identification  of starting materials (Raw Material – API & Excipient) in Quality Control Laboratory. Operation and Calibration of Melting Point Apparatus 1.0   PURPOSE: The purpose of this SOP is to describe the procedure for operation, calibration and maintenance of […]

Standard Operating Procedure (SOP) for operation and maintenance of Laboratory Oven used for glassware dying or Loss on Drying etc. in quality control laboratory. SOP for Laboratory Oven 1.0   PURPOSE: The purpose of this SOP is to describe the procedure for the operation and maintenance of a laboratory oven. 2.0   SCOPE: This SOP is applicable […]

Standard Operating Procedure (SOP) for operation, calibration, and maintenance of Bursting Strength Tester used to analyze the packing material of drug products. SOP for Bursting Strength Tester 1.0   PURPOSE: The purpose of this SOP is to describe the operation, calibration, and maintenance of the Bursting strength tester. 2.0   SCOPE: This SOP is applicable to the […]

Standard Operating System (SOP) for Operating, cleaning of Leak Test Apparatus which is used to check the leak seal test of packed strips, blisters, sachets, and bottle packs. Procedure For Leak Test (Leak Test Apparatus) 1.0   PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to describe the detailed procedure for checking the Leak […]

Standard Operating Procedure for Cleaning and Operation of Blister Packing Machine (BQS) used for the packing of the pharmaceutical drug products. SOP for Blister Packing Machine (BQS) 1.0   PURPOSE: The purpose of this SOP is to lay down the procedure for the cleaning and operation of the Blister Packing Machine (BQS). 2.0   SCOPE – SOP […]

Standard Operating Procedure (SOP) for the identification of requirement, procurement, handling, issuance, and destruction of Rubber Stereos used for batch details overprinting of various products. SOP FOR RUBBER STEREOS 1.0   PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to lay down the procedure for identity, procuring, handling, issuance, and destruction of rubber stereos […]

Standard Operating Procedure (SOP) for withdrawal and analysis of Stability Study Samples (Finished Drug Product) from stability chambers. Withdrawal and Analysis of Stability Study Samples 1.0   PURPOSE: The purpose of this  SOP is to define the procedure for Withdrawal and Analysis of Stability Study samples from the stability chamber. 2.0   SCOPE: This SOP is applicable […]

Standard Operating Procedure (SOP) for Fumigation of the Production area by using Virosil at pharmaceutical drug manufacturing plants. Fumigation in Production Area 1.0   PURPOSE: To lay down a procedure for the fumigation of the production area. 2.0   SCOPE: This standard operating procedure is applicable to the production area in pharmaceutical drug manufacturing plants. 3.0   RESPONSIBILITY […]

Standard Operating Procedure (SOP) for Operation and Cleaning of Metal Detector and Combo Metal Detector cum Deduster used during the manufacturing of drug products in pharmaceuticals. SOP for Metal Detector / Deduster 1.0   PURPOSE: The purpose of this SOP is to describe the cleaning and operation of metal detector and digital combo metal detector cum […]

Standard Operating Procedure (SOP) for cleaning and operation of Mechanical Stirrer used in granulation at drug product manufacturing in pharmaceuticals. SOP for Cleaning and Operation of Mechanical Stirrer 1.0   PURPOSE: The purpose of this SOP is to lay down the cleaning and operation procedure for Mechanical Stirrer. 2.0   SCOPE: This SOP is applicable for the […]

.perating Procedure (SOP) for General Check Point during Drug Product Batch Processing in the pharmaceuticals drug manufacturing plant. General Checks and Precautions During Processing of Batch 1.0   PURPOSE: The purpose of this SOP is to lay down the procedure for General Checks & Precautions during Processing of Batch. 2.0   SCOPE: This SOP is applicable for […]

Standard Operating Procedure (SOP) for handling and destruction of Non-Recoverable Recovery generated during the processing of pharmaceutical drug products. Handling and Destruction of non-recoverable Recovery 1.0   PURPOSE: The purpose of this SOP to lay down the procedure for handling and destruction of non-recoverable Recovery. 2.0   SCOPE: This SOP is applicable for followings, Handling and destruction […]

Standard Operating Procedure (SOP) for preparation, Issuance, and Execution of Stability Study Protocol, Analytical Template, and Specification of Drug Product. Stability Study Protocol, Template & Specification Preparation 1.0   PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for the preparation of the stability study protocol/template/Specification in the Quality Control department. […]

Standard Operating Procedure (SOP) for Operation and Calibration check of muffle furnace installed in quality control lab for analysis of sulfated ash, loss on ignition (LOI), etc. SOP for Muffle Furnace 1.0   PURPOSE: The purpose of this SOP is to describe the procedure for Operation and Performance Check procedure of Muffle Furnace and general practices […]

Standard Operating Procedure (SOP) for Operation and Calibration of vacuum oven used in quality control laboratory and R&D in pharmaceuticals. SOP for Vacuum Oven 1.0   PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for the Operation and Calibration of Vacuum Oven. 2.0   SCOPE: This SOP is applicable for the […]

Standard Operating Procedure (SOP) for Operation, Cleaning, and Qualification of Dynamic Pass Box used in the pharmaceutical manufacturing plant. Dynamic Pass Box used for the transfer of material from one area to another in isolation by means of mechanical/electromagnetic door interlocking process that ensures opening of only one door at a time. This process helps […]

Standard Operating procedure (SOP) for Operation, Cleaning, and Performance Check/Calibration of Stability chamber (Oven) used for the stability study of drug products.  Handling of Stability Chamber/Oven 1.0   Purpose: The purpose of this SOP is to describe the procedure for qualification and monitoring of the stability chamber/oven. 2.0   Scope: This procedure is applicable to the stability […]

Standard Operating Procedure (SOP) for Milli Q Water purification system for its operation, and general maintenance procedure. SOP for Milli Q Water System 1.0   PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to describe the operation and maintenance procedure of the Milli Q Water System. 2.0   SCOPE – SOP for Milli Q Water […]

Standard Operating Procedure (SOP) for Work Permit System in Pharmaceutical drug manufacturing plant. The work permit system is a formal written procedure used to control the hazards in non-routine work. The different work permit highlights the relevant hazards and precaution to be taken for the respective work before starting the activity. Procedure for Work Permit […]

Standard Operating Procedure for Environment, Health & Safety (EHS) Policy and procedure/practices at pharmaceutical drug manufacturing plants. Procedure / Policy: Environment, Health & Safety (EHS) 1.0   PURPOSE: The objective of the procedure is to define the company goal and driven procedures with respect to the top management. Establish the Environment, Health & Safety Management System […]

The Standard Operating Procedure (SOP) to describe the various aspect of Industrial Hygiene in pharmaceutical drug manufacturing plants. Industrial Hygiene – The science devoted to the anticipation, recognition, evaluation, prevention, and control of those occupational factors or stresses arising in or from the workplace which may cause sickness, impaired health and well being, or significant […]

Standard Operating Procedure (SOP) for Physical and Logical Control Policy of Computer system to fulfill the requirement of 21CFR Part 11 under the cGMP activity in the pharmaceutical drug manufacturing unit. Computer System Control Policy 1.0   Purpose: To define the process of the physical and logical security policy of the computer system. 2.0   Scope: This […]

Standard Operating Procedure (SOP) for Entry and Exit Procedure in Quality Control (QC) Laboratory in a pharmaceutical plant. Entry and Exit Procedure in QC Lab 1.0   PURPOSE: The purpose of this SOP is to laydown the entry and exit procedure for Quality Control (QC) Laboratory area. 2.0   SCOPE: This procedure shall be applicable to the […]

Standard Operating Procedure (SOP) for the operation of 1010 KVA Diesel Generating – DG Set installed for power backup in the pharmaceutical drug manufacturing plant. Procedure for Operating of 1010 KVA DG Set 1.0   PURPOSE: The purpose of this SOP is to define the procedure for the operation of the 1010 KVA DG set. 2.0  […]

Standard Operating Procedure (SOP) for Raw Material Reconciliation in the warehouse/store department in pharmaceuticals to maintain the stock of raw material.  Procedure for Raw Material Reconciliation 1.0   PURPOSE: The purpose of this SOP is to define the procedure for raw material reconciliation. 2.0   SCOPE: This procedure is applicable to all raw materials for verification of […]

Standard Operating Procedure (SOP) for sampling from different points and microbiological analysis/testing of Purified water samples in pharmaceutical plants. Sampling and Testing of Purified Water in Microbiology 1.0   PURPOSE: To lay down the procedure for Sampling and Testing of Purified Water. 2.0   SCOPE: This Standard Operating Procedure is applicable to the Microbiology Department. 3.0   REFERENCE: […]

Standard Operating Procedure (SOP) for Analyst/Chemist Qualification, Data Reviewer Qualification through performing parallel Analysis, and other evaluation parameters.  Procedure of Analyst / Reviewer Qualification 1.0   PURPOSE: The purpose of this SOP  is to describe the procedure for analyst/reviewer qualification. 2.0   SCOPE: The SOP is applicable for analyst/reviewer qualification in the Quality Control department at the […]

Standard Operating System (SOP) for Operation of Waters High-Performance Liquid Chromatography (HPLC) system. This procedure applies to the Waters – Alliance HPLC system. SOP for Waters HPLC System 1.0   Purpose : This SOP is to describe the operation procedure of the High-Performance Liquid Chromatographic (HPLC) system (Make-Waters, Model-Alliance) in the Quality Control Department. 2.0   Scope: […]

Standard Operating Procedure (SOP) for preparation, review, approval, issuance, maintenance, and archival of controlled Master Batch Record (MBR) throughout the product lifecycle to meet and maintain sustainable compliance to current Good Manufacturing Practices (cGMPs). SOP for Master Batch Record (MBR) 1.0   PURPOSE: The purpose of this procedure is to establish uniform requirements and guidelines utilizing […]

Standard Operating Practices (SOP) for the receipt, checking, passivation, storage, and disposal (handling) of Sieves/Screens. Procedure for Handling of Sieves and Screens 1.0   PURPOSE: The purpose of this SOP is to lay down the procedure for inspection & handling of Sieves and Screens. 2.0   SCOPE: This SOP is applicable to the receipt, checking, numbering, passivation, […]

Standard Operating Procedure (SOP/Guideline) for Packing of Drug Product. General rules to be adopted in the packing section for maintaining product identity, eliminating the potential mix-ups, handling of rejection, and smooth operation of the packing department. Guideline for Drug Product Packing 1.0   PURPOSE: The purpose of this SOP is to lay down general rules (to […]

Standard Operating Procedure (SOP) for Entry and Exit in the primary area of production at the pharmaceutical drug manufacturing plant. Procedure for Entry and Exit in the Primary Area 1.0   PURPOSE: The purpose of this SOP is to laydown the entry and exit procedure in the Primary Area of the production department at the pharmaceutical […]

Standard Operating Procedure (SOP) for Operation, Calibration, Cleaning and general maintenance of Jasco make Polarimeter instrument. Procedure for Operation, Calibration, and Cleaning of Polarimeter 1.0   Purpose: The purpose of this SOP is to describe the procedure for operation, cleaning, and calibration of the polarimeter. 2.0   Scope: This SOP  is applicable to the polarimeter available in […]

Standard Operating Procedure (SOP) for Operation and Cleaning of Neocota Coating Machine 48’’ & 60’’ used in the coating process. SOP for Neocota Coating Machine 1.0   Purpose: The purpose of this SOP is to describe the procedure for efficient cleaning & operation of Neocota 48’’ & 60’’ in the coating process. 2.0   Scope: This SOP […]

Standard Operating Procedure (SOP) for Operation, Calibration, and Cleaning of the Conductivity meter. Conductivity is the ability of a solution to conduct electricity and the electricity is conducted in solution by ions present unit of measurement of conductivity is Siemen (S). Procedure for Operation and Calibration of Conductivity Meter 1.0   PURPOSE: The purpose of this […]

Standard Operating Procedure (SOP) to establish the hold time of drug samples at the different stages of manufacturing (like starting material/Raw material, Intermediate and bulk product) prior to the final packing of the drug. Procedure to Establish the Hold Time of Samples Visit to copy this SOP 1.0   PURPOSE: The purpose of this SOP is […]

Standard Operating Procedure (SOP) for Cleaning and Operation Procedure for double rotary Tablet Compression Machine (45 And 55 Station). Operation and Cleaning Procedure of Tablet Compression Machine 1.0   PURPOSE: To lay down the efficient cleaning and operation of Double rotary compression machine Cadpress 45/55 stations Mark IV. 2.0   SCOPE: This procedure is applicable for the […]

Standard Operating Procedure (SOP) of Workplace instructions pertaining to health protocol during COVID-19 (Corona Virus) pandemic to be complied with by the pharmaceutical drug manufacturing plant. Health Protocol at the Workplace (Pharma) during COVID-19 (Corona Virus)   1.0   PURPOSE The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for health safety […]

Standard Operating Procedure (SOP) for the sampling of packing material (Primary Packing Material, Secondary Packing Material, and Tertiary Packing Material). Military Standard procedure. Procedure for Sampling and AQL of Packing Material 1.0   PURPOSE: The purpose of this SOP is to define the procedure for sampling and acceptance Quality level of packing materials. 2.0   SCOPE: This […]

Standard Operating Procedure (SOP) for Cleaning, Handling, and Storage of Fluid Bed Dryer FBD Bags for a different group of the drug product in the pharma plant.  Procedure for Cleaning, Handling, and Storage of FBD Bags 1.0   PURPOSE: The purpose of this SOP is to define the cleaning, handling, and storage of FBD bags. 2.0  […]

Standard Operating procedure (SOP) for identification and status label/labeling procedure of product, accessories equipment, and various manufacturing areas. Status Label/Labelling Procedure PURPOSE: To lay down the identification and status labeling procedure of Products, Containers, Accessories, Equipment, and Areas. SCOPE: This procedure is applicable to the WIP labels used in Warehouse, Granulation, Compression, Coating, Packing & […]

Standard Operating Procedure (SOP) for Batch Size Determination according to the chain of production equipment and equipment capacity. Batch Size determination based on the risk assessment.  Procedure for Determination of Batch Size 1.0      PURPOSE: This Standard Operating Procedure (SOP) describes in detail the procedure to be followed for the determination of the batch […]

Standard Operating Procedure (SOP) for Operation, Calibration, Cleaning, and Maintenance of FTIR (Fourier Transform Infrared Spectrometer). Procedure for Operation and Calibration of FTIR 1.0   PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to describe the start-up, operation, calibration, and maintenance procedure of the FTIR – Fourier Transform Infrared Spectrophotometer. Visit to copy this […]

Standard Operating Procedure (SOP) for Training Management of newly joined as well as an existing employee (staff and workers) working in a cGMP environment in pharmaceuticals.  Procedure for Training Management 1.0      PURPOSE: The purpose of this SOP is to describe the procedure to provide the guideline for training (TRN) of employees. 2.0    […]

Standard Operating Procedure (SOP) for Handling of Market Complaint of Finished Pharmaceutical Drug Product. A market/consumer complaint is a notification that the product in commercial distribution- May be in violation of the laws or regulations administered by the FDA. May have caused illness, injury or death. Is alleged to have caused problems not covered by […]

SOP for Operation and Calibration of Total Organic Carbon (TOC) analyzer. This measurement is proportional to the carbon in the sample. Carbon dioxide shows a unique adsorption spectrum when IR energy passes through it. Operation and Calibration of Total Organic Carbon (TOC) Analyzer 1.0         PURPOSE: To lay down the procedure for Operation […]

Standard Operating Procedure (SOP) for Water Sample Analysis as per IP/BP/USP. Procedure for chemical testing and microbiological testing of Raw/Tap water, RO water, and purified water samples. Procedure for Water Analysis (Chemical & Microbiological) 1.0      PURPOSE: To lay down a procedure for analysis of water samples (Chemical and Microbiological Analysis) 2.0      […]

Standard Operating Procedure (SOP) for using of Molybdenum Kit, This kit is used to check the content of molybdenum in stainless steel. Procedure for using of Molybdenum Kit 1.0      PURPOSE: The purpose of this SOP is to provide a guideline for carrying out the test of Stainless Steel (SS) surface with the Molybdenum […]

Standard Operating Procedure (SOP) for Line Clearance (LC) of the manufacturing area and equipment at the different stages of drug product manufacturing and packing in a pharmaceutical manufacturing plant. Procedure for Line Clearance of Area and Equipment 1.0       PURPOSE : The purpose of this SOP (Standard Operating Procedure) is to describe the procedure […]

Standard Operating Procedure (SOP) for Handling and Management of Incident / Deviation under the Quality Management System (QMS) in a pharmaceutical plant.  Handling and Control Procedure for Incident / Deviation  1.0       PURPOSE: This Standard Operating Procedure (SOP) defines the key elements and requirements for reporting, documenting, evaluating, managing and resolving deviations/incidents from cGxPs […]

Standard Operating Procedure (SOP) for Qualification of Instrument, Equipment, Facility & Utility in the pharmaceutical manufacturing plant.  Qualification: The action of proving and documenting that equipment or utility is properly installed, work correctly, and actually produce the expected results consistently. Procedure for Qualification of Equipment, Instrument, Facility & Utility 1.0      PURPOSE: The purpose […]

Standard Operating Procedure (SOP) for Handling of Data Integrity Observations (DIO) and Data Integrity Breach (DIB). Data Integrity is the extent to which all data are complete, consistent, truthful, traceable and accurate through the data life-cycle. Procedure For Handling of Data Integrity Observations 1.0      PURPOSE The purpose of this Standard Operating Procedure (SOP) […]

Standard Operating Procedure for the handling of Corrective and Preventive Action (CAPA). Corrective and Preventive Action (CAPA) is a concept with current Good Manufacturing Practice (cGMP) that focuses on the systematic investigation of root causes of unexpected incidences to prevent their recurrence (corrective action) or to prevent their occurrence (preventive action) Handling of Corrective and Preventive Action […]

Standard Operating Procedure for Waste Disposal in Pharmaceutical plants. Waste can be classified as Hazardous Waste, E-Waste, Biological Waste, etc. SOP for Disposal of Waste Materials in Pharma   1.0      Purpose : The purpose of the SOP to provide the written guidelines for the disposal of various types of waste material generated in […]

Standard Operating Procedure (SOP) for Review of Batch Manufacturing Record (BMR) and Batch Packing Record (BPR) in the pharmaceutical manufacturing plant. A detailed checklist for review of BMR and BPR for Draft Copy as well as  Filled Copy of Batch Manufacturing/Packing Records.  Procedure for BMR & BPR Review 1.0       PURPOSE: The purpose of […]

Standard Operating Procedure for maintenance of the building in different seasons/weather for cracks, chocked and drainage systems in a pharmaceutical manufacturing plant. Building and facilities demand continue up keeping, repair works or up-gradation work for floor, wall, and ceiling. Whenever it happens painting, rack repair, floor repair, surrounding maintenance are done is called Building Maintenance. […]

Standard Operating procedure (SOP) for material movement in pharmaceutical manufacturing premises form dispensing to the final product. whether material movement from one department to another or within the department. SOP for Material Movement In Manufacturing Premises 1.0      PURPOSE: The purpose of this SOP is to lay down the procedure for material movement procedures […]

Standard Operating Procedure (OOS) for the handling of Out of Specification Test Results, This SOP is designed based upon MHRA and WHO guideline for Handling of Out of Specification (OOS) results. In the SOP, Detailed procedure provided for the handling of out of specification (OOS) test results, preliminary investigation, Phase I, Phase II and Phase […]

Standard Operating Procedure (SOP) for Calibration of Gas Chromatography (GC), parameters are Carrier Gas flow Accuracy,  Calibration of Flame Ionization Detector (FID) by linearity Measurement, Calibration of Auto-injector by linearity measurement, Calibration for Column Oven temperature measurement, etc. SOP / Protocol for GC Calibration GC Calibration Procedure: At the time of calibration enter the details […]

Standard Operating Procedure (SOP) for Laboratory Instrument Qualification including User Requirement Specification (URS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Interim Qualification of Legacy Systems in Quality Control Laboratory. Procedure for Laboratory Instrument Qualification 1.0      PURPOSE The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for […]

Out of trend (OOT), results are those results that are within the specification but indicate that the particular analysis or process could be out of control. In case of stability out of trend (OOT) results describes as “A results that are within the specification but do not follow the trend, with respect to previous station […]

Standard Operating Procedure (SOP) for Sampling of Raw Material (API & Excipient) as per Schedule M and ICH Q7 (Good Manufacturing Practices Guideline). Raw Material sampling is the process of abstraction of a representative portion of material or a group of units from a larger quantity of material or collection of units. Procedure for Raw […]

Standard Operating Procedure for Dispensing of Raw Material (API-Active Pharmaceutical Ingredient and Excipient) to the production department for the manufacturing of pharmaceutical drug products.  1.0        PURPOSE: The purpose of this SOP is to define the procedure for dispensing of Raw Materials. 2.0      SCOPE: This procedure is applicable for dispensing of […]

Standard Operating Procedure for Qualification, Handling and Usage Of Reference Standards, Calibration Standards, Impurity Standards, Working Standards, and Working Standard Solvents. SOP for Laboratory Standard Management 1.0      PURPOSE: The purpose of this SOP is to describe the procedure for qualification, handling, storage and usage of reference standards (RS), calibration standards, impurity standards (IMS), […]

Standard Operating Procedure (SOP) for Electronic data backup, restoration, archival, retrieval and scheduled verification of stored data of quality control laboratory. SOP for Electronic Data Management (Laboratory) PURPOSE The purpose of this Standard Operating Procedure (SOP) is; To provide the procedures for Backup, Restoration, Archival and Retrieval of electronic data generated by Stand Alone/Server based […]

SOP for handling and reporting of Laboratory Incident (Lab Event ) occurs in the Quality Control like be-Bracketing standard failure, Improper peak shape, Extraneous peak, baseline disturbance, peak elution pattern change, Data missing, wrong standard/sample weight taken, wrong standard/sample preparation, wrong wavelength selection, wrong analytical column selection, etc. SOP for Handling and Reporting of Laboratory […]

Standard Operating Procedure (SOP) for Review of Analytical Report and Raw Data. Analytical raw data is data generated during sample analysis and includes traceability of equipment and reagents used for analysis e.g. name of the material, instrument ID, template, chromatograms (Electronic and hard copy), the potency of reference standard / working standard /reagent, calculations, results, […]

Standard Operating Procedure for Issuance / Dispensing of Packaging Material (Packing Materials) like Corrugated box, Primary Packaging Material (PPM), Secondary Packing Material, Aluminum Foils, BOPP tape, PVC Foils, etc. which is required to pack the drug product. Procedure for Packing Material Dispensing / Issuance 1.0      PURPOSE: The purpose of this SOP is to […]

Standard Operating Procedure (SOP) for Operation, standardization, calibration, and maintenance of pH meter including pH meter electrode care. SOP for Operation and Calibration of pH Meter 1.0      PURPOSE: The purpose of this SOP (Standard Operating Procedure) is to describe the procedure of operation, standardization, and maintenance of pH meter. 2.0      SCOPE: […]

Standard Operating Procedure (SOP) for Receipt, Storage, and Handling of Laboratory Reagents, Buffers, Solvents, Glasswares and other consumables in QC. Receipt, Storage, and Handling of Laboratory Reagents 1.0      Purpose : The purpose of this SOP ( Standard Operating Procedure) is to describe the procedure for the receipt, storage, and handling of laboratory reagents. […]

Standard Operating Procedure for Handling of Out of Calibration (OOC) for Laboratory Instrument and Equipment. The result which does not meet the pre-established acceptance criteria for the instrument calibration shall be termed as Out of Calibration (OOC).  SOP for Handling of Out of Calibration (OOC) Results 1.0      PURPOSE The purpose of this Standard […]

Standard Operating Procedure for Laboratory Instrument and Equipment calibration through Internal or External (Third Party). This SOP includes the calibration procedure, schedule/planner and frequency of Instrument calibration in quality control laboratory. SOP for Laboratory Instrument Calibration 1.0      Purpose: The purpose of this SOP ( Standard Operating Procedure) is to describe the procedure for […]

Checklist for review of microbiology data generated during the different tests of microbiology i.e. Antibiotic Assays, Particulate matter test, BET test, Preservative effectiveness testing ( Antimicrobial effectiveness testing), Microbial limit test (MLT), sterility, water analysis, and preservative effectiveness testing, Sterility testing. etc. Checklist for Microbiological Analytical Data and Reports Followings are the checkpoints during the […]

The Acceptable Quality Level (AQL) is a percent defective that is the baseline requirement for the quality of the producer’s product. The producer would like to design a sampling plan such that there is a high probability of accepting a lot that has a defect level less than or equal to the AQL. SOP for […]

Checklist for review of analytical raw data generated during the chemical analysis of finished drug product, the raw material (API-Active Pharmaceutical Ingredient / Excipient), Inprocess samples and stability study sample analysis. Checklist for Review of Analytical Raw Data (Test wise) 1.0      Product Information (Review of Raw Data / Report) : Name of material […]

Stability study sop prepared according to ICH guidelines with required stability study sample incubation, sample pullouts and analysis of samples and summary. SOP for Stability Study of Drug Product 1.0       Purpose: The purpose of this SOP is to describe the procedure for sample collection, selection of batches, incubation, withdrawal, analysis, reporting, and evaluation, […]

Standard Operating Procedure for Operation and calibration of UV cabinet for reviewing the TLC plate, Photolytic Degradation, UV cabinet Performance check. SOP for UV Cabinet (Operation & Calibration) 1.0       PURPOSE: The purpose of this Standard Operating Procedure ( SOP ) is to describe the procedure for suitability of the emission intensity of the […]

In the Quality Control Laboratory of the pharmaceutical product manufacturing unit, Different instruments, and equipment being used to analyze the drug product. the documented tracking or list of activities known as the Audit trail. An audit trail can be either a paper or electronically based trail that provides a documented history of a transaction within […]

Standard Operating Procedure (SOP) for Isolation and Identification of Microorganisms (Microbes). Isolation and Identification of Microorganisms 1.0      PURPOSE: To lay down the Procedure for Isolation and Identification of Microorganisms. 2.0     SCOPE: This Standard Operating Procedure is applicable to the Microbiology Department at the pharmaceutical manufacturing unit. 3.0      REFERENCE: SOP for […]

Quality Risk Management: An overall and continuing systematic process for the assessment, control, communication and review of risks to the quality of a pharmaceutical product or medical device across the product lifecycle in order to optimize its benefit-risk balance. SOP for Quality Risk Management 1.0       PURPOSE: This Standard Operating Procedure  (SOP) establishes uniform […]

The drug product recall is a process of removal or correction of marketed products for the reasons relating to deficiencies in quality, safety or efficacy, including labeling considered to be in violation of the laws. SOP for Product Recall 1.0      PURPOSE The purpose of this SOP is Effective and speedy withdrawal/ removal of […]

Standard operating procedure (SOP) for change control management. Change Control Procedure is a formal controlled documented process by which qualified representatives from appropriate discipline, review, propose and make changes to an approved system. SOP for Change Control Management 1.0       PURPOSE: This standard operating procedure defines the requirements to ensure changes to systems (includes […]

Standard Operating Procedure (SOP) for maintenance of laboratory instrument i.e. preventive maintenance, breakdown maintenance, etc. SOP for Maintenance of Laboratory Instrument 1.0      Purpose: The purpose of this SOP (Standard Operating Procedure) is to describe the procedure of instrument maintenance and preventive maintenance.  2.0     Scope: This procedure is applicable to the Instruments at […]

Standard Operating Procedure (SOP) for GC Columns, Receipt, performance check, usage, and maintenance of Gas Chromatography Column. SOP for GC Column: Receipt, Storage, Performance Check, Uses and Care 1.0       Purpose: The purpose of this SOP is to describe the procedure for the receipt, performance check, usage, and maintenance of GC Column. 2.0    […]

Standard Operating procedure for receipt and storage of raw material. Starting material such as API and excipient required in the manufacturing of drug product. Receipt and Storage of Raw Material  1.0       PURPOSE: The purpose of this SOP is to define the procedure for receipt and storage of raw materials used in various products. […]

Standard Operating Procedure (SOP) for disintegration apparatus (DT Apparatus) for operation and calibration as per IP containing various calibration parameters. Operation and Calibration of Disintegration Apparatus (DT) 1.0       PURPOSE: The purpose of this SOP is to describe the procedure for operation, calibration, and cleaning of the disintegration apparatus. 2.0      SCOPE: This […]

Standard Operating Procedure (SOP) for HOIST, containing Operation of L.T ElevatorOperation of Hyundai Elevator, Safety Precautions, etc. SOP for HOIST 1.0       PURPOSE: The purpose of this SOP is to define the procedure for the operation of the hoist. 2.0      SCOPE: This procedure is applicable to the operating procedure of Hoists at […]

Standard Operating Procedure for operation and cleaning of the colloid mill. contains Checks & Precautions, Cleaning procedure for product to product changeover, batch to batch changeover, etc. SOP for Operation and Cleaning of Colloid Mill 1.0       Purpose: The purpose of this SOP is to define the cleaning and operating procedure for Colloid Mill. 2.0  […]

Standard Operating Procedure (SOP) for operation and calibration of analytical balances. As per USP, balance calibration parameters are Internal adjustments, Linearity, Sensitivity, Repeatability (Uncertainty), and Accuracy, etc.  SOP for Analytical Balance: Operation and Calibration 1.0      PURPOSE The purpose of this SOP is to describe the procedure of Operation, Calibration, and Maintenance of Analytical […]

Standard Operating Procedure (SOP) for Analytical Solution Stability.  Procedure for stability study of solutions such as standard preparation, impurity solution, and system suitability solution, etc. SOP for Analytical Solution Stability 1.0       PURPOSE: The purpose of this SOP is to define the procedure for the solution stability (Use before date determination of solution(s) used […]

Standard Operation Procedure and Formats of ETP Effluent Treatment Plant  & Sewage Treatment Plant (STP) are defined below. For SOP, please click. SOP for Effluent Treatment Plant (ETP) and STP Annexure and Formats of ETP and STP 1.0      Daily ETP Performance & Operation Record (ETP Formats / Annexure 1) Date: _______________      […]

The manufacturer or supplier who is supplying the material in routine and registered for the supply of specific material after the approval process considered as an approved vendor. Vendor management consists of the Identification, Qualification, Requalification, management of changes at the vendor site, Vendor Audit, Technical Agreement, Deregistration Process, etc. Vendor Management 1.0       […]

The retention period for the Documents and Records in which record shall be retained /preserved in a facility according to their archival policy. The followings are the records and their recommended archival period. Record Retention and Archival Policy  in Pharmaceuticals 1.0    POLICY DOCUMENTS Sr. No. Document / Record Name Record Retention Period / Archival […]

A document is a physical or digital representation of a body of information designed with the capacity (and usually intent) to communicate. Below the Standard Operating System (SOP) for Document Management System. A document may manifest symbolic, diagrammatic or sensory-representational information. Following are some examples, but not limited to. SOP for Document Management System 1.0  […]

Process Validation: Establishing documented evidence through collection and evaluation of data from the process design stage to routine production, which establishes scientific evidence and provides a high degree of assurance that a process is capable of consistently yield products meeting pre-determined specifications and quality attributes. SOP and Protocol for Process Validation of Drug Product 1.0  […]

Technology transfer/product transfer is a complete documented process that covers the detailed documentation for manufacturing and dispatch of the first batch, received from the parent location or FDD of a new or existing product from a particular site with manufacturing, packaging, and analytical details. SOP on Technology Transfer of Drug Product 1.0      PURPOSE: […]

Standard Operating procedure (SOP) for rounding off figures, numbers of analytical test results, including assay result rounding off, related substances (RS) result and other laboratory generated quantitative value and their reporting system. SOP for Rounding Off Test Results 1.0      PURPOSE: The purpose of this SOP is to describe    the    standard for “Rounding off” […]

A microbial culture (microbiological culture) is a procedure of growing microbial organisms (reproduction) by allowing them to breed in programmed culture medium under controlled laboratory conditions. Microbial cultures are initial and basic diagnostic methods used as a research tool in molecular biology. Microbial Culture Management Standard Operating Procedure (SOP) 1.0   PURPOSE: To lay down the […]

Reduce Testing in Raw Material Standard Operating Procedure  (SOP) for Reduce Testing in Raw Material (API and excipients), This will help to increase the productivity of Quality Control for speedy release of RM. 1.0     PURPOSE: The purpose of this SOP is to describe the procedure for  reduce testing in analysis of raw materials.. 2.0  […]

Control Sample is an appropriately identified reserve samples that is representative of each batch, in the same container closer system in which the product is marketed. It may Starting Material, Packaging Material, Drug Substance or Finished Drug Product which is stored to evaluate the potential risk during self life of the batch. Sample should be […]

The Development of hand-held Raman Spectrometers has drastically changed the manner of internal control for incoming raw material. Raman has provided advantages over alternative ways in this. It doesn’t need sample pre-treatment or direct contact with the sample, and has the unique capability of having the ability to check a sample directly through a clear wadding like glass or plastic. With the additional benefit of portability, hand-held Raman spectrometers significantly increase potency/productivity by eliminating […]

Introduction : Cleaning is necessary to avoid cross contamination from one product to another. Cleaning process used for cleaning of equipments needs to be established to ensure that it is capable of consistently achieving desired level of cleanliness. To ensure the state of cleaning Hold time Study is required. This validation study to be executed for […]

Internal Audit (Self Inspection) checklist for various departments of Pharmaceuticals like Quality Control, Quality Assurance, Production, HR and EHS etc. Below Internal Audit (Self Inspection) checklist being used for the assessment of respective departments . these are the minimum requirement for the compliance. It would be the agenda of Internal Audit (Self Inspection) checklist. Copy […]

In the SOP on Internal Audit and Self Inspection, describe the detailed procedure to carryout the the Self inspection and Internal Audit in various department of pharmaceuticals. Audit is a systemic and independent examination to determine the quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are […]

The SOP for the operation of the Effluent Treatment Plant (ETP) and Sewage Treatment Plant (STP) to define the comprehensive procedure for handling the waste of pharmaceuticals. Effluent Treatment Plant (ETP) – The mechanism or process used to treat the wastewater prior to release into the environment or its reuse. Sewage Treatment Plant (STP) -It […]

Annual Product Review (APR) is the requirement of various regulatory agencies. APR roots the monitoring of product quality as well as finding out the scope of quality improvement by controlling the critical process parameters (CPP). Visit to copy this SOP APR – Annual Product Review also known as APQR – Annual Product Quality Review and […]

LAF : Laminar Air Flow –  Airflow which is linear and positive up to working surfaces and thus prevents contamination of surrounding viable/ non viable particulate matter in aseptic handling. The Operation, Cleaning, Maintenance and Qualification of Laminar Air Flow (LAF) shall discussed in below SOP. Laminar Air flow (LAF) – Operation, Cleaning and Qualification […]

Calibration of UV spectrophotometer (UV-VIS Spectrophotometer) for all parameters as per IP, BP and USP pharmacopoeia like, Internal Calibration, Match pairing of UV cell / cuvette, Control of wavelength, control of Absorbance, Limit of Stray light, Resolution and Resolution Power, Linearity Study and 2nd derivatives. UV Calibration / Calibration of UV Spectrophotometer : Parameters : […]

Cleaning and sanitization of Utility system and Equipment is crucial to maintain the Quality of the drug product and to avoid the cross contamination also Standard Operating Procedure for Cleaning and Sanitization PURPOSE: The purpose of this Standard Operation Procedure is Defines the requirements Ensure that facility and Equipment Cleaning and Sanitization are managed and […]

In Pharmaceutical industries Quality Control (QC) is believe as one of the most vital department.It acts as a barrier between the manufacturing unit and Market to ensure the Quality of the manufactured product. In Quality Control Functions Large numbers of employees are work together in QC department at different grade with a common Aim, which […]

The Quality Control Laboratory in the Pharmaceutical plants plays the critical role to maintain, monitor and consistent product of Pharmaceutical products. In the laboratory from starting material to finished products being tested at the different manufacturing stages. Good Laboratory Practices assist to perform the timely and accurate analytical results. In the day to day activities […]

Quality Assurance Department Functions in Pharmaceuticals : Quality Assurance Department shall function for assuring the quality of all the Products manufactured, at every stage of manufacturing / processing of Drug Products. This shall be achieved by performing the functions of monitoring as per the laid systems for the following areas which is not limited to […]

Cleaning of laboratory glassware is the key for success of an analysis in the Pharmaceutical Quality Control Laboratory. Even the maximum cautiously performed laboratory analysis can produced erroneous/wrong results if uncleaned glassware is being used during the analysis. If the glassware that is used for measuring solvent / sample solution or standard solutions is contaminated […]

This article is to describe the process and requirements regarding Sample Management in Quality Control Laboratory , including the receipt, handling, controls, maintenance, distribution for testing, and destruction. The implementation of this procedure provides documented records of the chain of custody for the test samples to ensure their accountability and tractability. This article (Laboratory Sample […]

A cleaning validation protocol format shall be developed for the ‘worst case’ product selected for cleaning validation programme. Following information (but not limited to) the following included in the cleaning validation protocol. Numbering of protocol shall done through of respective SOP of Cleaning Validation Protocol Numbering. Cleaning Validation Protocol Format – Objective: A brief description […]

Introduction: Cleaning validation Master Plan will function as an umbrella guidance document for all the cleaning validation protocols, programs, and procedures adopted to ensure that all the equipment utilized for the manufacturing of tablets and hard gelatin capsules dosage form are cleaned up an acceptable level. The Pharmaceuticals manufacturing entities which  engaged in manufacturing of […]

A Complete Guide on HPLC Calibration – Part 3 of 3 (Continued…) In the HPLC Calibration – A complete guide article series, we have discussed about Monthly & Quarterly Calibration parameters, rest of the parameters are described below, in the end of the article all the relevant links has mentioned, in this article there are […]

Continued from …. A Complete Guide on HPLC Calibration -Part 1 of 3 Part 2 – HPLC Calibration on different Parameter starts from Energy check and completed on wavelength accuracy of Detector In the previous article on HPLC Calibration we have covered following parameters. Pressure Test. Drift and Noise Column oven and sample cooler Pump […]