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 […]