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The new document answers questions regarding implementation of the ICH Q7 guidance on GMPs for APIs.
On April 19, 2018, FDA published a guidance document that answers questions about the implementation of the International Council for Harmonization (ICH) Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. ICH Q7 helps pharmaceutical companies ensure that APIs meet quality and purity characteristics. This Q&A document is in response to industry requests for clarification of some ICH Q7 sections.
Topics addressed in the Q&A document include quality management, personnel training, facilities, process equipment, documentation, materials management, production, storage, and validation. Specifically, the document clarifies requirements for releasing raw materials, sampling, product quality review, risk management, acceptance criteria, evaluation of material suppliers, and more.