The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Handling of Complaints Standard Operating Procedure for Handling of Complaints 1) Purpose The purpose of this SOP is to define the procedure for receiving, documenting, evaluating, and resolving complaints related to pharmaceutical products in order to ensure customer satisfaction and compliance with regulatory requirements. 2) Scope This SOP applies to all personnel involved…
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 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 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 Visual Inspection of Vials Standard Operating Procedure for Visual Inspection of Vials 1) Purpose The purpose of this SOP is to establish a standardized procedure for the visual inspection of vials to ensure they are free from defects and contamination. 2) Scope This SOP applies to all vials used for the packaging of…
SOP for Conductivity Testing Standard Operating Procedure for Conductivity Testing 1) Purpose The purpose of this SOP is to establish a standardized procedure for performing conductivity testing on pharmaceutical products to ensure they meet quality standards and regulatory requirements. 2) Scope This SOP applies to all pharmaceutical products that require conductivity testing within the facility,…
SOP for pH Testing Standard Operating Procedure for pH Testing 1) Purpose The purpose of this SOP is to establish a standardized procedure for performing pH testing on pharmaceutical products to ensure they meet quality standards and regulatory requirements. 2) Scope This SOP applies to all pharmaceutical products that require pH testing within the facility,…
SOP for Particulate Matter Testing Standard Operating Procedure for Particulate Matter Testing 1) Purpose The purpose of this SOP is to establish a standardized procedure for performing particulate matter testing in pharmaceutical products to ensure they meet quality standards and regulatory requirements. 2) Scope This SOP applies to all pharmaceutical products that require particulate matter…
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SOP for Endotoxin Testing Standard Operating Procedure for Endotoxin Testing 1) Purpose The purpose of this SOP is to outline the procedures for performing endotoxin testing on pharmaceutical products to ensure they are free from pyrogenic contamination. 2) Scope This SOP applies to all pharmaceutical products that require endotoxin testing within the facility, including raw…
SOP for Sterility Testing Standard Operating Procedure for Sterility Testing 1) Purpose The purpose of this SOP is to establish a standardized procedure for performing sterility testing of pharmaceutical products to ensure they are free from viable microorganisms. 2) Scope This SOP applies to all pharmaceutical products that require sterility testing within the facility, including…