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May 16, 2023
  • Quality Control and Quality Assurance: To ensure that pharmaceutical manufacturing facilities comply with regulatory requirements, it is important to establish both quality assurance (QA) and quality control (QC) as separate functions from the approved procedures and regulatory requirement
  • Facilities and Equipment Manufacturing facilities should be designed, constructed, and maintained with the goal of preventing errors that could impact product safety, quality, or efficacy, such as cross-contamination or mix-ups. Therefore, equipment and utility systems need to be validated, regularly calibrated, and qualified to comply with regulatory requirements.
    • Personnel: All individuals participating in the production or testing of an ATMP must be fully aware of their assigned tasks and responsibilities, and knowledgeable about the product as applicable. Personnel should be qualified through a validated training program and regularly assessed to update their knowledge and skills.
    • Documentation: Comprehensive written procedures and records should be established, controlled, and maintained to document all aspects of manufacturing and control of medicinal products. The records should provide evidence of adherence to established procedures, methods, and specifications.
        • Material Management: Materials used in the manufacture of medicinal products should be of appropriate quality and specification. They must be received, identified, sampled, tested, and stored under appropriate conditions to prevent contamination, errors, mix-ups, or other quality failures.
        • Production and Process Controls: The manufacturing process should be controlled and monitored to ensure that product quality is maintained within predetermined limits. This includes using utilizing validated methodologies, performing in-line quality checks, employing appropriate equipment, and managing the facility environment and conditions.
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