SOP for Audit Trail Review and Management SOP for Audit Trail Review and Management 1) Purpose To define procedures for the review and management of audit trails generated by computerized systems within the pharmaceutical manufacturing facility, ensuring compliance with regulatory requirements. 2) Scope This SOP applies to all computerized systems and personnel involved in the…

SOP for Emergency Preparedness and Response SOP for Emergency Preparedness and Response 1) Purpose To establish procedures for emergency preparedness, response, and recovery to mitigate potential risks and ensure the safety of personnel and resources within the pharmaceutical manufacturing facility. 2) Scope This SOP applies to all employees, contractors, and visitors within the pharmaceutical manufacturing…

SOP for Handling of Hazardous Waste SOP for Handling of Hazardous Waste 1) Purpose To establish procedures for the safe handling, storage, and disposal of hazardous waste generated during pharmaceutical manufacturing processes. 2) Scope This SOP applies to all personnel involved in the generation, handling, and disposal of hazardous waste within the pharmaceutical manufacturing facility….

SOP for Contamination Control SOP for Contamination Control 1) Purpose To establish procedures for controlling contamination in pharmaceutical manufacturing processes to ensure product quality and regulatory compliance. 2) Scope This SOP applies to all personnel involved in manufacturing, packaging, and testing of pharmaceutical products within the facility. 3) Responsibilities Quality Assurance: Responsible for implementing and…

SOP for Handling Highly Potent Substances SOP for Handling Highly Potent Substances 1) Purpose To establish procedures for the safe handling, storage, and disposal of highly potent substances to ensure employee safety and regulatory compliance. 2) Scope This SOP applies to all personnel involved in the handling of highly potent substances within the pharmaceutical manufacturing…

SOP for Media Fill Studies SOP for Media Fill Studies 1) Purpose To establish procedures for conducting media fill studies to evaluate the aseptic manufacturing process and ensure sterility assurance of products in pharmaceutical manufacturing. 2) Scope This SOP applies to all media fill studies conducted within the pharmaceutical manufacturing facility to validate aseptic processing…

SOP for Validation Protocols (IQ, OQ, PQ) SOP for Validation Protocols (Installation Qualification, Operational Qualification, Performance Qualification) 1) Purpose To define the procedures for conducting Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to ensure that equipment, systems, and processes meet predefined acceptance criteria and comply with regulatory requirements in pharmaceutical manufacturing. 2)…

SOP for Validation Master Plan (VMP) SOP for Validation Master Plan (VMP) in Pharmaceutical Manufacturing 1) Purpose To establish a Validation Master Plan (VMP) that outlines the strategy and framework for validating critical systems, processes, and equipment within the pharmaceutical manufacturing facility to ensure compliance with regulatory requirements and maintain product quality. 2) Scope This…

SOP for Management of Change SOP for Management of Change in Pharmaceutical Manufacturing 1) Purpose To establish a procedure for the management of change (MoC) in pharmaceutical manufacturing processes to ensure controlled implementation, evaluation, and documentation of changes that may impact product quality, safety, or efficacy. 2) Scope This SOP applies to all changes initiated…

SOP for Computerized Systems Validation SOP for Validation of Computerized Systems in Pharmaceutical Manufacturing 1) Purpose To establish procedures for the validation of computerized systems used in pharmaceutical manufacturing processes to ensure data integrity, reliability, and compliance with regulatory requirements. 2) Scope This SOP applies to all computerized systems used in the pharmaceutical manufacturing facility,…