The Ultimate Resource for Pharmaceutical SOPs and Best Practices
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.
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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.
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To establish procedures for the safe handling, storage, and disposal of hazardous waste generated during pharmaceutical manufacturing processes.
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To establish procedures for controlling contamination in pharmaceutical manufacturing processes to ensure product quality and regulatory compliance.
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To establish procedures for the safe handling, storage, and disposal of highly potent substances to ensure employee safety and regulatory compliance.
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To establish procedures for conducting media fill studies to evaluate the aseptic manufacturing process and ensure sterility assurance of products in pharmaceutical manufacturing.
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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.
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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.
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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.
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To establish procedures for the validation of computerized systems used in pharmaceutical manufacturing processes to ensure data integrity, reliability, and compliance with regulatory requirements.
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