The Ultimate Resource for Pharmaceutical SOPs and Best Practices
Standard Operating Procedure for Handling and Testing of Microbial Toxins 1. Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the safe handling, storage, and testing of microbial toxins in the laboratory or research facility. This SOP ensures that all personnel involved in working with microbial toxins follow strict safety…
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Standard Operating Procedure for Growth Promotion Testing of Antimicrobial Susceptibility Testing Media 1. Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for conducting growth promotion testing of antimicrobial susceptibility testing (AST) media. This SOP ensures that the AST media used for bacterial susceptibility testing are of consistent and reliable quality,…
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Standard Operating Procedure for Water Testing SOP Version: 1.0 Purpose: The purpose of this Standard Operating Procedure (SOP) is to establish guidelines and procedures for water testing in the pharmaceutical manufacturing facility. Water testing is performed to assess the microbiological quality and purity of water used in various manufacturing processes, in compliance with relevant pharmacopeias…
Standard Operating Procedure for Bioburden Testing SOP Version: 1.0 Purpose: The purpose of this Standard Operating Procedure (SOP) is to establish guidelines and procedures for bioburden testing in the pharmaceutical manufacturing facility. Bioburden testing is performed to determine the level of viable microorganisms present in raw materials, intermediate products, or finished pharmaceutical products, in compliance…
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Standard Operating Procedure for Microbial Limit Testing SOP Version: 1.0 Purpose: The purpose of this Standard Operating Procedure (SOP) is to establish guidelines and procedures for microbial limit testing in the pharmaceutical manufacturing facility. Microbial limit testing is performed to determine the microbial load in pharmaceutical products or raw materials, ensuring compliance with relevant pharmacopeial…
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Standard Operating Procedure for Sterility Testing SOP Version: 1.0 Purpose: The purpose of this Standard Operating Procedure (SOP) is to establish guidelines and procedures for sterility testing in the pharmaceutical manufacturing facility. Sterility testing is performed to ensure the absence of viable microorganisms in pharmaceutical products, as per the requirements outlined in relevant pharmacopeias and…
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Standard Operating Procedure for Air Sampling for Environmental Monitoring SOP Version: 1.0 Purpose: The purpose of this Standard Operating Procedure (SOP) is to establish guidelines and procedures for air sampling during environmental monitoring in the pharmaceutical manufacturing facility. Air sampling is conducted to assess the microbial contamination in critical areas, equipment, and utilities, in compliance…
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Standard Operating Procedure for Settle Plate Method for Environmental Monitoring SOP Version: 1.0 Purpose: The purpose of this Standard Operating Procedure (SOP) is to outline the guidelines and procedures for the settle plate method used in environmental monitoring within the pharmaceutical manufacturing facility. The settle plate method is employed to assess the microbial contamination in…
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Standard Operating Procedure for Contact Plate Method for Environmental Monitoring: SOP Version: 1.0 Purpose: The purpose of this Standard Operating Procedure (SOP) is to outline the guidelines and procedures for the contact plate method used in environmental monitoring within the pharmaceutical manufacturing facility. The contact plate method is employed to assess the microbial contamination on…
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Standard Operating Procedure for Swabbing for Environmental Monitoring SOP Version: 1.0 Purpose: The purpose of this Standard Operating Procedure (SOP) is to outline the guidelines and procedures for swabbing during environmental monitoring in the pharmaceutical manufacturing facility. Swabbing is a method used to assess the microbial contamination on surfaces in critical areas, equipment, and utilities,…
