The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Container-Closure System Testing Procedure for Container-Closure System Testing 1) Purpose The purpose of this SOP is to outline the procedure for testing container-closure systems used for pharmaceutical products to ensure integrity and suitability for maintaining product quality and safety. 2) Scope This SOP applies to all container-closure systems (e.g., vials, bottles, ampoules) used…
SOP for Product Recall Management Standard Operating Procedure for Product Recall Management 1) Purpose This SOP outlines the procedures for initiating, executing, and documenting product recalls to ensure prompt and effective management of product quality issues, protection of public health, and compliance with regulatory requirements. 2) Scope This SOP applies to all personnel involved in…
SOP for Handling of Hazardous Materials Standard Operating Procedure for Handling of Hazardous Materials 1) Purpose The purpose of this SOP is to establish safe and standardized procedures for the handling, storage, and disposal of hazardous materials in the manufacturing environment to ensure the safety of personnel and compliance with regulatory requirements. 2) Scope This…
SOP for UV Exposure Testing Procedure for UV Exposure Testing 1) Purpose The purpose of this SOP is to outline the procedure for conducting UV exposure testing on pharmaceutical products to assess the impact of UV radiation on product stability and quality. 2) Scope This SOP applies to all pharmaceutical products susceptible to degradation from…
SOP for Raw Material Procurement Raw Material Procurement – Standard Operating Procedure 1) Purpose To outline the process for procuring raw materials used in pharmaceutical manufacturing to ensure quality, availability, and compliance with regulatory standards. 2) Scope This SOP applies to the procurement of raw materials within the pharmaceutical purchase department. 3) Responsibilities Procurement Manager:…
SOP for Product Complaint Handling Standard Operating Procedure for Product Complaint Handling 1) Purpose This SOP outlines the procedures for receiving, documenting, investigating, and resolving product complaints to ensure timely and effective management, assessment of product quality, and compliance with regulatory requirements. 2) Scope This SOP applies to all personnel involved in receiving, documenting, investigating,…
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SOP for Light Exposure Testing Procedure for Light Exposure Testing 1) Purpose The purpose of this SOP is to outline the procedure for conducting light exposure testing on pharmaceutical products to assess the potential impact of light exposure on product stability and quality. 2) Scope This SOP applies to all pharmaceutical products susceptible to degradation…
SOP for Water for Injection (WFI) Generation Standard Operating Procedure for Water for Injection (WFI) Generation 1) Purpose The purpose of this SOP is to establish procedures for the generation of Water for Injection (WFI) to ensure it meets quality standards for use in the manufacturing process. 2) Scope This SOP applies to all personnel…
SOP for Humidity Mapping of Storage Areas Procedure for Humidity Mapping of Storage Areas 1) Purpose The purpose of this SOP is to outline the procedure for conducting humidity mapping studies in storage areas to ensure uniformity and stability of humidity conditions for stored pharmaceutical products. 2) Scope This SOP applies to all storage areas…
SOP for Out-of-Specification (OOS) Results Standard Operating Procedure for Out-of-Specification (OOS) Results 1) Purpose This SOP outlines the procedures for handling and investigating Out-of-Specification (OOS) results encountered during testing of pharmaceutical products to ensure accurate and reliable data, compliance with regulatory requirements, and appropriate corrective actions. 2) Scope This SOP applies to all personnel involved…