The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Operation of Autoclaves Standard Operating Procedure for Operation of Autoclaves 1) Purpose The purpose of this SOP is to outline the procedures for the safe and effective operation of autoclaves used for sterilizing equipment, media, and other materials in the manufacturing facility. 2) Scope This SOP applies to all personnel involved in the…
SOP for Cleaning of Manufacturing Equipment Standard Operating Procedure for Cleaning of Manufacturing Equipment 1) Purpose The purpose of this SOP is to establish a standardized procedure for the cleaning of manufacturing equipment to prevent contamination and ensure product quality and safety. 2) Scope This SOP applies to all manufacturing equipment used in the production…
SOP for Process Validation Standard Operating Procedure for Process Validation 1) Purpose The purpose of this SOP is to outline the procedures for validating manufacturing processes to ensure they consistently produce products meeting predetermined quality attributes. 2) Scope This SOP applies to all manufacturing processes within the facility that require validation, including new processes, changes…
SOP for Stability Testing of IV Injections Standard Operating Procedure for Stability Testing of Intravenous (IV) Injections 1) Purpose The purpose of this SOP is to establish a standardized procedure for conducting stability testing of intravenous (IV) injections to ensure their safety, efficacy, and quality throughout the product’s shelf life. 2) Scope This SOP applies…
SOP for Disposal of Waste Materials Standard Operating Procedure for Disposal of Waste Materials 1) Purpose The purpose of this SOP is to establish procedures for the proper disposal of waste materials generated during manufacturing processes, ensuring compliance with environmental regulations and maintaining a safe and clean work environment. 2) Scope This SOP applies to…
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 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 Raw Material Testing and Approval Standard Operating Procedure for Raw Material Testing and Approval 1) Purpose The purpose of this SOP is to establish procedures for the testing and approval of raw materials to ensure they meet specified quality standards before use in the manufacturing process. 2) Scope This SOP applies to all…
SOP for Raw Material Storage Standard Operating Procedure for Raw Material Storage 1) Purpose The purpose of this SOP is to establish procedures for the proper storage of raw materials to ensure their quality and integrity are maintained until they are used in the manufacturing process. 2) Scope This SOP applies to all personnel involved…
SOP for Pest Control Management Standard Operating Procedure for Pest Control Management 1) Purpose The purpose of this SOP is to establish procedures for pest control management to prevent contamination and ensure a hygienic manufacturing environment. 2) Scope This SOP applies to all personnel involved in pest control management at [Company Name] in the production…