SOP for Document Control and Management Standard Operating Procedure for Document Control and Management 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish a framework for the creation, review, approval, distribution, and maintenance of documents within the pharmaceutical manufacturing facility to ensure accuracy, traceability, and compliance with regulatory requirements. 2) Scope…

SOP for Handling and Storage of Controlled Substances Standard Operating Procedure for Handling and Storage of Controlled Substances 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the secure handling, storage, and disposal of controlled substances within the pharmaceutical manufacturing facility to prevent unauthorized access, diversion, or misuse. 2)…

SOP for Handling of Out-of-Specification Results Standard Operating Procedure for Handling of Out-of-Specification Results 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for the handling and investigation of out-of-specification (OOS) results in pharmaceutical manufacturing to ensure product quality and compliance with regulatory requirements. 2) Scope This SOP applies…

SOP for Calibration of Analytical Instruments Standard Operating Procedure for Calibration of Analytical Instruments 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for the calibration of analytical instruments used in pharmaceutical manufacturing to ensure accurate and reliable analytical results. 2) Scope This SOP applies to all personnel involved…

SOP for Monitoring and Controlling Temperature and Humidity in Storage Areas Standard Operating Procedure for Monitoring and Controlling Temperature and Humidity in Storage Areas 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for monitoring and controlling temperature and humidity in storage areas within the pharmaceutical manufacturing facility to…

SOP for Visual Inspection of Packaging Materials Standard Operating Procedure for Visual Inspection of Packaging Materials 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for the visual inspection of packaging materials used in pharmaceutical manufacturing to ensure compliance with quality standards and regulatory requirements. 2) Scope This SOP…

SOP for Label Control and Accountability Standard Operating Procedure for Label Control and Accountability 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for controlling and maintaining accountability of labels used in pharmaceutical manufacturing to ensure accurate labeling of products. 2) Scope This SOP applies to all personnel involved…

SOP for Validation of Analytical Methods Standard Operating Procedure for Validation of Analytical Methods 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for the validation of analytical methods used in the analysis of pharmaceutical products to ensure accuracy, reliability, and reproducibility of results. 2) Scope This SOP applies…

SOP for Stability Testing of IM and SC Products Standard Operating Procedure for Stability Testing of IM and SC Products 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for conducting stability testing of Intramuscular (IM) and Subcutaneous (SC) products to assess their quality, safety, and efficacy over time….

SOP for Cleaning Validation for Filling Equipment Standard Operating Procedure for Cleaning Validation for Filling Equipment 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for validating the cleaning process of filling equipment used in pharmaceutical manufacturing to prevent cross-contamination and ensure product quality and safety. 2) Scope This…