On April 19th, 2018 the US Food and Drug Administration (FDA) finalised the International Council for Harmonisation’s (ICH) Q7 question and answer guidance on good manufacturing practices (GMPs) for active pharmaceutical ingredients (APIs). The finalisation of the guidance follows its endorsement by the regulatory agencies participating in 2015 ICH. The question and answer (Q&A) document that has just been issued is intended to respond to requests for clarification of uncertainties due to the interpretation of certain sections of the ICH guidance Q7 Good Manufacturing Practice Guidance for APIs. This ICH guidance is intended to provide guidance regarding GMPs for the manufacturing of APIs under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess. ICH Q7 helps pharmaceutical companies ensure that APIs meet quality and purity characteristics. Topics addressed in the Q&A document include
- Quality Management
- Personnel Training
- Process Equipment
- Materials Management
- 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. The Q&A states “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 good manufacturing practices (GMPs) at all stages of the active pharmaceutical ingredients (API) supply chain, including distribution. A table is provided as an annex of this document showing the link between each Q&A and the relevant sections of ICH Q7 and other ICH Quality guidance.” Some examples of questions addressed are
- Should GMP according to ICH Q7 be applied for manufacturing steps before the defined API starting material……?
- What is the intent of the statement in ICH Q7, paragraph 3.12 “training should be periodically assessed”?
- Is it possible to extend the expiry date or retest date of a raw material and what is the acceptable practice to determine how long it may be extended for?