Worldwide GMP RegulationsIn the United States, the Food and Drug Administration (FDA) change their interpretation of GMPs as situations evolve. The changes made in these interpretations are not published in any single update, nor collected in any publication available to the general public. Therefore, it takes constant monitoring and a deep understanding of how FDA operates to understand and anticipate GMP requirements.
24 countries have national GMP regulations 4 regional groups have GMPs (and each of the 24 nations with internal regulations are members of at least one of these groups thereby creating confusion as to what the requirement really may be.)
Association of South-East Asian Nations (ASEAN) European Community (EC) Pharmaceutical Inspection Convention (PIC) World Health Organization (WHO)
Wednesday, 13 April 2011
JAMES HARRIS ASSOCIATES INC.
http://www.jamesharris.com/services.htmGood Manufacturing Practice regulations (GMPs) often seem to be a mysterious, ever-changing set of instructions written in some unknown language. Perhaps this is because virtually every major industrialized nation has written and rewritten their own pharmaceutical GMP regulations and continue to modify them on an ad hoc basis.
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In the United States, the Food and Drug Administration (FDA) change their interpretation of GMPs as situations evolve. The changes made in these interpretations are not published in any single update, nor collected in any publication available to the general public. Therefore, it takes constant monitoring and a deep understanding of how FDA operates to understand and anticipate GMP requirements.
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