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 […]
Environment, Health And Safety Policy (EHS) – SOP
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 […]
Good Laboratory Practices (GLP) – SOP & Guideline
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 – SOP for Safety Management
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 […]
Investigation of Extraneous Peak in Chromatography
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 […]
Handling of Rejected Raw and Packing Materials
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). […]
Reconciliation of Packing Materials and Bulk-SOP
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 […]
Purified Water Plant – Operation and Regeneration
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 […]
Auto Titrator – Operation and Calibration SOP
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 Limit in Raw Material (API) – SOP
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 […]
Documentum Software – Guideline for Operation
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 […]
Micropipette Calibration and Operation Procedure
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 […]
Particle Size Analyzer (Malvern) Operation Calibration
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 […]
Field Alert Report (FAR) – Guidance for Submission
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 and Inhibition Test of Media
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 […]
SOP for Handling of Returned Goods / Materials
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, […]
Micro Balance – Operation and Calibration SOP
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 […]
Disinfectants & Sanitizer Efficacy Testing Protocol
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 […]
Drug Product (Finished, Stability) Sampling Procedure
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 […]
Handling of Outliers in Near Infrared (NIR) Analysis
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 […]
Guideline for Equipment and System Qualification
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 […]
Water Storage Tank – Procedure for Cleaning
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 […]
Documentum Software – Guideline for Operation
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 […]
Micropipette Calibration and Operation Procedure
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 […]
Particle Size Analyzer (Malvern) Operation Calibration
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 […]
Field Alert Report (FAR) – Guidance for Submission
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 and Inhibition Test of Media
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 […]
SOP for Handling of Returned Goods / Materials
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, […]
Micro Balance – Operation and Calibration SOP
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 […]
Disinfectants & Sanitizer Efficacy Testing Protocol
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 […]
Drug Product (Finished, Stability) Sampling Procedure
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 […]
Handling of Outliers in Near Infrared (NIR) Analysis
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 […]
Guideline for Equipment and System Qualification
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 […]
Water Storage Tank – Procedure for Cleaning
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 […]
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