The United States (US) Food and Drug Administration (FDA) have finalised the International Council for Harmonisation’s (ICH) Q7 question and answer (Q&A) guidance on good manufacturing practices (GMPs) for active pharmaceutical ingredients (APIs). The Q&A document is intended to provide guidance regarding GMP for the manufacturing of APIs under an appropriate system for managing quality. The guidance also aims to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess.
Since the ICH Q7 guidance was finalised, experience with implementing the guidance worldwide has led to requests for clarification of uncertainties due to the interpretation of various sections, thus the Q&A document intends to respond to these requests. The finalisation of the 24-page guidance follows its endorsement by the regulatory agencies participating in ICH in June 2015 and features Q&A’s on quality management, personnel, buildings and facilities, process equipment, documentation and records, storage and distribution, including other topics.
The Q&A guidance states that “the ICH Q7 document should be read in its entirety regardless of the nature of the manufacturing activities being conducted to fully understand the linkages between certain sections and successfully implement appropriate GMPs at all stages of the API supply chain, including distribution.” In the annex of the Q&A document a table has been provided which shows the link between each Q&A and the relevant sections of ICH Q7 and other ICH Quality guidance. It is also noted in the Q&A that ICH Q7 should be applied in combination with the principles from development and manufacturing in ICH Q11, Quality Risk Management (ICH Q9) and Pharmaceutical Quality Systems (ICH Q10).
The finalisation of the Q&A document follows Japan’s Pharmaceutical and Medical Devices Agency (PMDA) in 2016 joining with the FDA, the European Medicines Agency (EMA) and other regulators to improve the efficiency and effectiveness of GMP inspections for sites producing APIs.
To view the FDA’s Q&A document on GMP guidance for APIs, please click here.