Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (APIs)

  • By: Staff Editor
  • Date: April 18, 2017
  • Source:
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Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (APIs)

The quality and the stability of Active Pharmaceutical Ingredients (APIs) are vital for the overall quality, safety and efficacy of human drug products. Thus, APIs for pharmaceutical use and those used for manufacturing drugs for clinical trials are highly regulated. The US FDA has had an extensive set of GMP requirements for APIs for several decades now and still guidelines are continually being revised.

FDA has recently published the revised GMP guidance for APIs. The revised guidance replaces the Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients and changes the ICH codification from Q7A to Q7. This guidance document addresses GMPs for managing quality for APIs including principles of quality management, responsibilities of quality unit and production activities, internal audits, and product quality review.

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Good Manufacturing Practices (GMPs) for Phase I Investigational Drugs


This guidance document applies to the APIs used in human drug products. It covers APIs that are manufactured by chemical synthesis, extraction, cell culture and fermentation, recovery from natural sources, or any combination of these processes. However, the regulatory document does not cover the following APIs:

  • All vaccines
  • Whole cells
  • Whole blood and plasma
  • Blood and plasma derivatives
  • Gene therapy
  • Medical gases
  • Radiopharmaceuticals

Summary of Requirements

The GMP guidance document details the requirements for:

  • Quality Management
  • Personnel
  • Building and Facilities
  • Process Equipment
  • Documentation and Records
  • Materials Management
  • Production and in-process Controls
  • Packaging and Identification Labeling of APIs and Intermediates
  • Storage and Distribution
  • Laboratory Controls
  • Validation
  • Change Control
  • Complaints and Recalls
  • Contract manufacturers including Laboratories

The guidance further addresses the recommendations for agents, brokers, traders, distributors, repackers, and relabellers to ensure clarity in adhering to the FDA GMP requirements.

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