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    Good Documents Practice in Pharma

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    Prince Moni
    Good documentation practices are essential in the pharmaceutical industry for several reasons: 1) Documentation provides written proof that activities occurred; 2) Documentation is necessary for regulatory compliance and business objectives like quality control; 3) The FDA requires adherence to Good Documentation Practices under cGMP regulations. Key aspects of Good Documentation Practices include ensuring information is true, accurate, timely, and legible.

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    Good Documents Practice in Pharma

    Uploaded by

    Prince Moni
    169 views2 pages
    Good documentation practices are essential in the pharmaceutical industry for several reasons: 1) Documentation provides written proof that activities occurred; 2) Documentation is necessary for regulatory compliance and business objectives like quality control; 3) The FDA requires adherence to Good Documentation Practices under cGMP regulations. Key aspects of Good Documentation Practices include ensuring information is true, accurate, timely, and legible.

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    Good documents practice in pharma

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    Good documents practice in pharma

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    Good documentation practices are essential in the pharmaceutical industry for several reasons: 1) Documentation provides written proof that activities occurred; 2) Documentation is necessary for regulatory compliance and business objectives like quality control; 3) The FDA requires adherence to Good Documentation Practices under cGMP regulations. Key aspects of Good Documentation Practices include ensuring information is true, accurate, timely, and legible.

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    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    169 views2 pages

    Good Documents Practice in Pharma

    Uploaded by

    Prince Moni
    Good documentation practices are essential in the pharmaceutical industry for several reasons: 1) Documentation provides written proof that activities occurred; 2) Documentation is necessary for regulatory compliance and business objectives like quality control; 3) The FDA requires adherence to Good Documentation Practices under cGMP regulations. Key aspects of Good Documentation Practices include ensuring information is true, accurate, timely, and legible.

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    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
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    Good documents practice in pharma

    What is Document:

    A piece of written, printed, or electronic matter that provides information or evidence or


    proof of any activity that serves as an official record.

    Why Good Documents are Required in Pharmaceuticals :

    1.If it isn’t documented, it didn’t happen & we document to provide written proof that
    something happened.

    2.For regulatory requirements & business reasons- intent of making quality product or cost
    saving improvements.

    3.To Compliance with the Food and Drug Administration’s (FDA), Good Laboratory
    Practices, regulations (21 CFR Part 58), as well as GMP (Good Manufacturing practices)
    regulations for drugs and   medical devices (21 CFR Parts 211 and 820) requires the use of
    Good Documentation Practices.

    4.Good Documentation Practices (GDP) apply to everyone who documents activities related
    to cGMP (Current Good Manufacturing practices).

    5.A key to Good Documentation Practices is to consider these questions each time you
    record your raw data:

      a. is it true?                                c.    Is it timely?

     b.  is it accurate?                        d.    Is it legible?

    What is Good Manufacturing practices (GMP) :


    It is a system for ensuring that products are consistently produced and controlled according
    to quality standards. It is designed to minimize the risks involved in any
    pharmaceutical production that cannot be eliminated through testing the final product.

    What is Current Good Manufacturing practices (cGMP) :

    The letter “c” stands for “current,” reminding manufacturers that they must employ
    technologies and systems that are up-to-date in order to comply with the regulation.

    What is Standard Operating Procedure (SOP) :

    A Standard Operating Procedure (SOP) is a set of written instructions that document a


    routine or repetitive activity which is followed by employees in an organization.

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