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he guidance addresses the good manufacturing practice for managing quality in APIs.
On Sept. 29, 2016, FDA published the revised Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, Guidance for Industry. The guidance document address good manufacturing practices (GMPs) for a quality management system for APIs. The guidance also helps companies ensure the purported API quality and purity characteristics are met. The guidance replaces Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients and changes the International Council for Harmonization (ICH) codification from Q7A to Q7.
The revised guidance addresses all aspects of API manufacture including the principles of quality management, the responsibilities of the quality unit, production activities, internal audits, and product quality reviews. Personnel qualifications, hygiene, and the qualification of consultants are discussed. The guidance also details GMP requirements for facility design and construction and equipment used. Several other API manufacturing topics, including materials management, process controls, laboratory controls, packaging, storage and distribution, validation, and change control, are discussed.