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  • Title: International Conference on Harmonisation; guidance on good manufacturing practice for active pharmaceutical ingredients; availability. Notice.
    Author: Food and Drug Administration, HHS.
    Journal: Fed Regist; 2001 Sep 25; 66(186):49028-9. PubMed ID: 12358036.
    Abstract:
    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes current good manufacturing practice (CGMP) for manufacturing of active pharmaceutical ingredients (APIs). The guidance is intended to help ensure that all APIs meet the standards for quality and purity they purport or are represented to possess.
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