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  • DocumentationandMaintenance PDF

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    Prashanth Puttapaga
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    DocumentationandMaintenance.pdf

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    7 views4 pages

    DocumentationandMaintenance PDF

    Uploaded by

    Prashanth Puttapaga

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
    Flag for inappropriate content
    of 4
    Abstract f ciy & no Proper documentation and record maintenance is a principal step in good manufacturing practice regulations that a pharmaceutical ‘manufacturer must follow. Documentation provides a thorough knowledge of the history and the present status of the ‘manufacturing batches. Thus it provides a basis of what should be done in future or forthe improvement inthe process. Effective documentation provides the required information to the authorized personnel for the release of the batch. It also provides the specifications or the procedures for manufacturing and control of the drug products. A brief overview for the importance of ‘documentation and record maintenance in pharmaggutical sectoris outlined her. Key words Good manufacturing practices, documentation, records, pharmaceuticals, protocols, validation, Introduction Good Manufacturing Practice (GMP) is that part of quality assurance which ensures that products (drug or medicinal) are ‘consistently produced and controlled to the quality standards ‘appropriate to their intended use and as required by the marketing authorization (MA) or product specification. GMP. guidelines are not normative instructions for manufacturing a

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