Scribd Logo
Upload

Welcome to Scribd!

  • Assignment #1 Sterile Injectable Facilities List of Related Annexes Based On GMP

    Uploaded by

    Syazwan Ghazali
    14 views1 page
    The document lists 19 annexes related to good manufacturing practices for sterile injectable facilities. The annexes cover topics such as the manufacture of sterile medical products for human and veterinary use, sampling procedures, computer systems validation, investigational products, blood and plasma derived products, qualification and validation, batch release, and guidelines for active pharmaceutical ingredients. The list was prepared by Syazwan Ghazali on March 8, 2011.

    Original Description:

    Original Title

    Assignment 1

    Copyright

    © Attribution Non-Commercial (BY-NC)

    Available Formats

    DOC, PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    Report this Document
    The document lists 19 annexes related to good manufacturing practices for sterile injectable facilities. The annexes cover topics such as the manufacture of sterile medical products for human and veterinary use, sampling procedures, computer systems validation, investigational products, blood and plasma derived products, qualification and validation, batch release, and guidelines for active pharmaceutical ingredients. The list was prepared by Syazwan Ghazali on March 8, 2011.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as DOC, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    14 views1 page

    Assignment #1 Sterile Injectable Facilities List of Related Annexes Based On GMP

    Uploaded by

    Syazwan Ghazali
    The document lists 19 annexes related to good manufacturing practices for sterile injectable facilities. The annexes cover topics such as the manufacture of sterile medical products for human and veterinary use, sampling procedures, computer systems validation, investigational products, blood and plasma derived products, qualification and validation, batch release, and guidelines for active pharmaceutical ingredients. The list was prepared by Syazwan Ghazali on March 8, 2011.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as DOC, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 1

    Assignment #1

    Sterile Injectable Facilities

    List of related Annexes based on GMP:

    1 Manufacture of terial Medicinal Product


    2 Manufacture of Biological Product for Human Use

    4 Manufacture of Veterinary Medicinal Products other then Immunological

    5 Manufacture of Immunological Veterinary Medical Products

    8 Sampling of Starting & Packaging Material

    11 Computerized System

    13 Manufacture of Investigational Medicinal Products

    14 Manufacture of Products derived from Human Blood or Human Plasma

    15 Qualification & Validation


    16 Qualified Person & Batch Release

    17 Parametric Release

    18 GMP Guide for Active Pharmaceutical Ingridient

    19 Reference & Retention sample

    Prepared by,

    Syazwan Ghazali

    Date: 8th March 2011

    You might also like