The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Internal Quality Audits Standard Operating Procedure for Internal Quality Audits 1) Purpose This SOP outlines the procedures for conducting internal quality audits to assess compliance with established quality management systems, identify areas for improvement, and ensure adherence to regulatory requirements. 2) Scope This SOP applies to all departments and functions within the company…
SOP for Blister Pack Integrity Testing Procedure for Blister Pack Integrity Testing 1) Purpose The purpose of this SOP is to outline the procedure for testing the integrity of blister packs used for packaging pharmaceutical products to ensure they meet quality and safety standards. 2) Scope This SOP applies to all blister packs used for…
SOP for Packaging Material Procurement Packaging Material Procurement – Standard Operating Procedure 1) Purpose To define the process for procuring packaging materials used in pharmaceutical packaging to ensure quality, compliance, and availability. 2) Scope This SOP applies to the procurement of packaging materials within the pharmaceutical purchase department. 3) Responsibilities Procurement Manager: Responsible for overseeing…
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…