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ICH Q7: API Guidelines

ICH Q7: API Guidelines

The ICH Q7 guideline provides details of  Good Manufacturing Practice (GMP) for Active Pharmaceutical Ingredients (API). It is a guideline adopted globally for applying GMP to APIs (drug substances) and is crucial to ensure consistent quality and safety throughout the API manufacturing process.  This guideline was developed at a time when there were several regional guidelines and is important since it is a globally agreed consensus between multiple regulatory agencies and industry representatives on how GMP should be applied to API manufacturing.
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