FDA issues guidance on good manufacturing practice for APIs

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The US Food and Drug Administration (FDA) has finalized revised guidance on good manufacturing practice (GMP) for active pharmaceutical ingredients (APIs).

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The document is based on the International Conference on Harmonization (ICH) Q7 guidelines and uses a question and answer format to provide responses to requests for clarification of uncertainties due to the interpretation of certain sections in the ICH guidance.

It provides guidance regarding GMP for the manufacturing of APIs under an appropriate system for managing quality. It also provides guidance to help companies ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess. 

Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
Date: April 2018

FDA states that it ‘generally’ expects annual product quality reviews but time frames can be adjusted to ‘encompass more or less than 12 months’, depending upon product campaign duration.

The agency also makes it clear that product quality reviews should still be carried out even if no manufacturing took place in the review period and should include complaints, returns, recalls and stability, as well as trend analysis.

The European Medicines Agency (EMA) and FDA agreed in 2017 to recognize GMP inspections of pharmaceutical manufacturing sites conducted in their respective territories on both sides of the Atlantic [1].

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1. GaBI Online - Generics and Biosimilars Initiative. EMA and FDA to recognize GMP inspections [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 8]. Available from: www.gabionline.net/Policies-Legislation/EMA-and-FDA-to-recognize-GMP-inspections

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Source: US FDA

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