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    GMPNote

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    Yogesh Chaudhari
    This document provides explanatory notes for a WHO certificate that certifies the status of pharmaceutical manufacturing sites. It specifies that the certificate should include: 1) The certification number that is traceable within the regulatory authority. 2) The dosage forms, starting materials, categories and activities in Table 1, including examples of products like tablets, injectables, and starting materials like paracetamol. 3) The certificate remains valid until the specified expiration date and becomes invalid if the certified activities or categories change or if the site is no longer GMP compliant.

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    GMPNote

    Uploaded by

    Yogesh Chaudhari
    37 views1 page
    This document provides explanatory notes for a WHO certificate that certifies the status of pharmaceutical manufacturing sites. It specifies that the certificate should include: 1) The certification number that is traceable within the regulatory authority. 2) The dosage forms, starting materials, categories and activities in Table 1, including examples of products like tablets, injectables, and starting materials like paracetamol. 3) The certificate remains valid until the specified expiration date and becomes invalid if the certified activities or categories change or if the site is no longer GMP compliant.

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    GMP Note

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    This document provides explanatory notes for a WHO certificate that certifies the status of pharmaceutical manufacturing sites. It specifies that the certificate should include: 1) The certification number that is traceable within the regulatory authority. 2) The dosage forms, starting materials, categories and activities in Table 1, including examples of products like tablets, injectables, and starting materials like paracetamol. 3) The certificate remains valid until the specified expiration date and becomes invalid if the certified activities or categories change or if the site is no longer GMP compliant.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    37 views1 page

    GMPNote

    Uploaded by

    Yogesh Chaudhari
    This document provides explanatory notes for a WHO certificate that certifies the status of pharmaceutical manufacturing sites. It specifies that the certificate should include: 1) The certification number that is traceable within the regulatory authority. 2) The dosage forms, starting materials, categories and activities in Table 1, including examples of products like tablets, injectables, and starting materials like paracetamol. 3) The certificate remains valid until the specified expiration date and becomes invalid if the certified activities or categories change or if the site is no longer GMP compliant.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    of 1

    Explanatory notes

    1. This certificate which is in the format recommended by WHO, certifies the status of the site listed
    in point 1 of the certificate.

    2. The certification number should be traceable within the regulatory authority issuing the
    certificate.

    3. Where the regulatory authority issues a licence for the site , this number should be specified
    record “not applicable” in cases where there is no legal framework for the issuing of a licence.

    4. Table 1
    List the dosage forms, starting materials, categories and activities. Examples are given below.

    Example -1

    Pharmaceutical Product (s)1 Category (ies) Activity (ies)


    Dosage form (s)
    Tablets Cytotoxic Packaging
    Hormone Production, Packaging, Quality
    control.
    Injectables Penicillin Repackaging & Labelling.
    Cefalosporin Aseptic preparation, Packaging,
    Labelling.

    Example - 2.

    Pharmaceutical Product (s)1 Category (ies) Activity ( ies )


    Starting material (s)2
    Paracetamol Analgesic Synthesis, Purification,
    Packing, Labelling.

    Use, whenever available. International Nonproprietary Names (INNs) or otherwise national


    nonproprietary names.

    5. The certificate remains valid until the specified date. The certificate becomes invalid if the
    activities and/or categories certified are changed or if the site is no longer considered to be in
    compliance with GMP.

    6. The requirements for good practices the manufacture and quality control of drugs referred to in
    the certificate are those included in Quality Assurance of Pharmaceuticals: a compendium of
    guidelines and related materials . Good manufacturing practices and inspection. Volume 2,
    1999. World Health Organization, Geneva and subsequent updates.

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