US cGMP requirements for supplements

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US cGMP in Manufacturing, Packaging, Labelling or Holding Operations for Dietary Supplements

Summary of Requirements for Testing and Documentation

Within the FSE GMP Guide many of these requirements appear as an advised ‘should do‘, whereas within the US cGMP they are a compulsory ‘must do‘. Similarly the FSE GMP Guide uses ‘umbrella’ terminology where the US cGMP spells out in precise detail exactly what documentation or what testing must be provided/carried out for each stage or process.

Published: July 2017

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