The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Microbial Monitoring Standard Operating Procedure for Microbial Monitoring 1) Purpose The purpose of this SOP is to establish a standardized procedure for performing microbial monitoring in the manufacturing environment to ensure control over microbial contamination. 2) Scope This SOP applies to all areas within the facility where pharmaceutical products are manufactured, including cleanrooms…
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 Document Control Document Control – Standard Operating Procedure 1) Purpose To establish guidelines for controlling the creation, review, approval, distribution, and maintenance of documents within the pharmaceutical manufacturing department. 2) Scope This SOP applies to all documents, including procedures, specifications, forms, and records, that are critical to the quality and compliance of pharmaceutical…
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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 Media Fill Validation Standard Operating Procedure for Media Fill Validation 1) Purpose The purpose of this SOP is to establish a standardized procedure for performing media fill validation to ensure the aseptic manufacturing process is capable of producing sterile products. 2) Scope This SOP applies to all aseptic manufacturing processes that require media…
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 Material Handling Material Handling – Standard Operating Procedure 1) Purpose To establish guidelines for the safe and efficient handling of materials within the warehouse or manufacturing environment. 2) Scope This SOP applies to all material handling activities including receipt, storage, retrieval, and distribution within the facility. 3) Responsibilities Warehouse Team: Responsible for executing…
SOP for Consistency Testing in Topical Preparations Procedure for Consistency Testing in Topical Preparations 1) Purpose The purpose of this SOP is to outline the procedure for testing consistency in topical preparations to ensure uniformity and quality. 2) Scope This SOP applies to all topical preparations requiring consistency testing as part of quality control measures…
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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 Grittiness Testing in Topical Preparations Procedure for Grittiness Testing in Topical Preparations 1) Purpose The purpose of this SOP is to outline the procedure for testing grittiness in topical preparations to ensure product quality and patient satisfaction. 2) Scope This SOP applies to all topical preparations requiring grittiness testing as part of quality…
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