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Good Manufacturing Practices Introduction - GMP. Xin Chen and Chris Lepine. Some questions to consider:. What are some good rules for manufacturing companies? Do you usually trust people that you do not know with your life? How well do people regulate themselves?. >.

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Good Manufacturing Practices Introduction - GMP


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    1. Good Manufacturing Practices Introduction - GMP Xin Chen and Chris Lepine

    2. Some questions to consider: • What are some good rules for manufacturing companies? • Do you usually trust people that you do not know with your life? • How well do people regulate themselves? >

    3. FDA mission • Overview • Protect public health • Promote public health • Coordinate regulatory requirements across countries

    4. How does FDA accomplish its mission? • Establishing and enforcing high product standards and other regulatory requirements • Regulating the labeling of products under its jurisdiction >

    5. What products are regulated by FDA? • All foods except meat and poultry • Prescription and non-prescription drugs • Biologics • Medical devices and radiological products • Animal drugs and feed • Cosmetics

    6. FDA organization

    7. A question to consider: • Why do we have traffic laws?

    8. What is cGMP?– Current Good Manufacturing Practice Requirements that manufacturers of regulated healthcare products must follow so that the products they make have the safety, identity, strength, and quality that they purport or are represented to have. >

    9. cGMP compliance • Ensure safety, quality, and effectiveness of drugs, biologics and medical devices • Non-compliance • Business failure – recall, seizure, fines, imprisonment • Public health at risk

    10. Evolution of cGMP • Early 1900’s: The Jungle • 1906: Creation of FDA • 1938: Creation of FD&C Act • Requirement for pharmacological study to prove drug safety • 1962: Drug Amendment • Requirement for testing on human subjects • Today: 21 CFR

    11. Essence of cGMP • Protection from contamination • Mix-ups prevention • Know what you are to do before you do it • Documentation • Consistency and control • Independent decision-making • Continuous improvement

    12. Other questions to consider: • Why do we want consistencies in our lives? • How do you make sure your cakes turn out right every time? >

    13. Understanding SOP • Standard Operation Procedure • Written instruction • What to do • How to do it • What is SOP for? • Provide consistency • Minimize mistakes • Where to find it? • Online • Check with your supervisor

    14. Understanding SOP (contd.) • SOP is constantly changing • SOP life cycle SOP Status = Progress SOP Status = In Review SOP Status = Effective SOP Status = Approved Learner completes SOP Training SOP Status = In Training

    15. Good Manufacturing Practices Introduction - GMP Xin Chen and Chris Lepine