Regulatory
World Health Organisation Good Manufacturing Practices — international standard for pharmaceutical production.
The WHO defines GMP as “the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.” Consistently is the point: GMP is about the process reliably producing the same result, not about testing a finished batch into compliance.
The WHO’s definition. National regulators apply their own GMP rules, which may differ from the WHO’s.
From the AJG lexicon archive (July 2026).
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