The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Particulate Matter Testing Standard Operating Procedure for Particulate Matter Testing 1) Purpose This SOP outlines the procedures for testing particulate matter in pharmaceutical products to ensure compliance with quality standards and regulatory requirements. 2) Scope This SOP applies to the testing of particulate matter in injectable and other pharmaceutical products, including vials, ampoules,…
SOP for Leak Testing of Sealed Containers Standard Operating Procedure for Leak Testing of Sealed Containers 1) Purpose This SOP outlines the procedures for conducting leak testing of sealed containers to ensure integrity and quality of packaging for pharmaceutical products. 2) Scope This SOP applies to the leak testing of sealed containers used for pharmaceutical…
SOP for Visual Inspection of Injectable Products Standard Operating Procedure for Visual Inspection of Injectable Products 1) Purpose This SOP outlines the procedures for visually inspecting injectable products to ensure they meet quality standards and are free from defects before release for distribution. 2) Scope This SOP applies to the visual inspection of all injectable…
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SOP for Media Fill Validation Standard Operating Procedure for Media Fill Validation 1) Purpose This SOP outlines the procedures for conducting media fill validation to simulate the aseptic filling process and ensure that the production environment, personnel, and processes are capable of producing sterile pharmaceutical products. 2) Scope This SOP applies to all aseptic filling…
SOP for Growth Promotion Testing Standard Operating Procedure for Growth Promotion Testing 1) Purpose This SOP outlines the procedures for conducting growth promotion testing to ensure that culture media used in microbiological testing is capable of supporting the growth of microorganisms, thereby ensuring the reliability and accuracy of microbiological test results. 2) Scope This SOP…
SOP for Bioburden Testing Standard Operating Procedure for Bioburden Testing 1) Purpose This SOP outlines the procedures for conducting bioburden testing on pharmaceutical products to ensure they meet acceptable microbiological quality standards, ensuring product safety and compliance with regulatory requirements. 2) Scope This SOP applies to all pharmaceutical products requiring bioburden testing, including raw materials,…
SOP for Microbial Limits Testing Standard Operating Procedure for Microbial Limits Testing 1) Purpose This SOP outlines the procedures for conducting microbial limits testing on pharmaceutical products to ensure they meet acceptable microbiological quality standards, ensuring product safety and compliance with regulatory requirements. 2) Scope This SOP applies to all pharmaceutical products requiring microbial limits…
SOP for Endotoxin Testing Standard Operating Procedure for Endotoxin Testing 1) Purpose This SOP outlines the procedures for conducting endotoxin testing on pharmaceutical products to ensure they are free from endotoxins and safe for use, complying with regulatory standards. 2) Scope This SOP applies to all batches of pharmaceutical products that require endotoxin testing, including…
SOP for Pyrogen Testing Standard Operating Procedure for Pyrogen Testing 1) Purpose This SOP outlines the procedures for conducting pyrogen testing on pharmaceutical products to ensure they are free from pyrogens and safe for use, complying with regulatory standards. 2) Scope This SOP applies to all batches of pharmaceutical products that require pyrogen testing, including…
SOP for Sterility Testing Standard Operating Procedure for Sterility Testing 1) Purpose This SOP outlines the procedures for conducting sterility testing of pharmaceutical products to ensure they are free from viable contaminating microorganisms, ensuring product safety and compliance with regulatory standards. 2) Scope This SOP applies to all sterile pharmaceutical products manufactured and tested within…