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    Developing Procedures to Meet GMP Requirements

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    A comprehensive set of documented quality procedures is required by the Food and Drug Administration's Good Manufacturing Practices. In order to successfully develop a comprehensive set of procedures, the motivation must be to maintain quality and reduce variability. Quality system procedures should follow a logical structure. One such structure consists of tiered Quality Policies, Administrative Support Procedures, and Technical Procedures. Each procedure should be traceable to a requirement established in the Quality Policy Manual. Once an effective set of procedures is in place it must be actively managed. Procedure management includes mechanisms for keeping the documents current, ensuring accessibility to the procedure users, and training on the use of the procedures.


    Quality, Procedures, GMP, Quality System, Documentation, Quality Management, ISO 9000

    Author Information:

    Malooley, MJ
    Vice President, Principal Engineer, Performance Solutions, Inc., Indianapolis, IN

    Committee/Subcommittee: E48.06

    DOI: 10.1520/STP14712S