SOP for Protocol and Report Numbering System
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 […]
Specimen Signature Recording SOP of Employee
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: […]
Refrigerator – Operation & Performance Check
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 […]
New Product Introduction (Risk Evaluation)
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 […]
UPLC System Calibration Procedure
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, […]
LOD Oven – Operation and Maintenance SOP
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 […]
Flame Photometer – Operation and Calibration 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 […]
Cross Contamination, Mix-Ups & Microbial Contamination
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 […]
Sieve Shaker – Operation and Cleaning SOP
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 […]
Good Documentation Practices – SOP & Guideline
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 […]
Cobb Tester – Operation and Cleaning SOP
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 […]
Calibration of HPLC System – SOP and Format
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. […]
Friability Apparatus – Operation & Calibration SOP
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 […]
Calibration Program – SOP & Policy
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 […]
Out of Specification (OOS) in Packaging Material
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 […]
Yield Fixation and Evaluation at Different Processing Stages
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 […]
Fire System – Operation and Maintenance SOP
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 […]
Contract Laboratory Agreement and Testing SOP
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 […]
Investigation Tools used in Pharma – SOP & Guideline
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 […]
Handling of Returned Raw & Packing Material – SOP
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: […]
Good Warehousing Practices – SOP & Guideline
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 […]
Cleaning of Pre-Filters, Microvee and Cartridge Filter
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 […]
Site Master File (SMF) Preparation SOP & Guideline
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 […]
SOP for Training of Contractual Worker
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 […]
Pest & Rodent Control in Pharmaceuticals – SOP
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 for Microbiological Testing
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 […]
Procedure for Housekeeping of the Factory Premises
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 […]
Yield Fixation and Evaluation at Different Processing Stages
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 […]
Fire System – Operation and Maintenance SOP
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 […]
Contract Laboratory Agreement and Testing SOP
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 […]
Investigation Tools used in Pharma – SOP & Guideline
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 […]
Handling of Returned Raw & Packing Material – SOP
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: […]
Good Warehousing Practices – SOP & Guideline
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 […]
Cleaning of Pre-Filters, Microvee and Cartridge Filter
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 […]
Site Master File (SMF) Preparation SOP & Guideline
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 […]
SOP for Training of Contractual Worker
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 […]
Pest & Rodent Control in Pharmaceuticals – SOP
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 for Microbiological Testing
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 […]
Procedure for Housekeeping of the Factory Premises
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 […]
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