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…
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…
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…
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 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…
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…
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…
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…
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…
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…