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Current Good Manufacturing Practices (cGMP)

    What are Current Good Manufacturing Practices?

    This includes high-level practices like design controls, document control, production control, supplier control, quality inspection, labeling, packaging, CAPAs, complaint handling, and other activities.

    Importance of Current Good Manufacturing Practices

    The importance of cGMP is to ensure the safety and efficacy of the device through these practices by upholding quality devices.

    What are the 5 main components of good manufacturing practice?

    • PreMarket Activities
    • Supplier controls
    • Inspections
    • Postmarket Activities

    The difference between cGMP vs GMP


    GMP guidelines emphasize the importance of documentation to demonstrate compliance with quality standards. This includes documentation of manufacturing processes, quality control testing, and product distribution.

    • Been in place for several decades and have evolved in response to technological changes, industry practices, and regulatory requirements.


    cGMP regulations typically have more detailed requirements for documentation, including the use of batch records, standard operating procedures (SOPs), and validation documentation.

    -represents the current iteration of GMP standards. As industry practices and regulatory expectations evolve, updates are made to the guidelines to reflect the latest best practices and standards.

    3 Common Violations of Current Good Manufacturing Practice Regulations

    • Lack of written documentation
    • Insufficient testing
    • Facility and Equipment Deficiency

    Preventing CGMP Violations

    • Establish Robust Quality Management Systems
    • Provide Adequate Training and Education
    • Conduct Regular Audits and Inspections
    • Implement Risk-Based Approach
    • Ensure Proper Facility and Equipment Maintenance
    • Implement Robust Change Control Procedures
    • Monitor Supplier and Vendor Performance
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