WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 13): Good Practices in Production and Quality Control
(2006; 30 pages)
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Good Practices

QC Access

  • QC Personnel must have access to production areas:

    - for sampling

    - and investigation

  • As appropriate

QC personnel must have access to production areas for, for example, sampling and inspection. However, this must be balanced because it may not be appropriate, for instance, to have QC staff enter aseptic filling suites, or areas where there is highly potent dangerous material such as oncology (or cytotoxic material) or anovulent hormones.

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Dernière mise à jour: le 3 mai 2013