Since its appearance in August 2007, the Guidance for Industry, ICH Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients has stood the test of time in providing clear and practical guidance to the pharmaceutical industry, as described in the guidance’s original objective, “provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality”.  As evidence of the quality and overall usefulness of ICH Q7A, there has been no revision or amendment to the guidance since its original publication.

However, now, in April 2018, comes the Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Questions and Answers Guidance for Industry here ).  In the “Objective” section, the new Q & A Guidance notes that, with regards to the original ICH Q7A Guidance, “experience with implementing the guidance worldwide has given rise to requests for clarification of uncertainties due to the interpretation of certain sections.  This question and answer (Q & A) document is intended to respond to those requests.”

The new ICH Q7 Q&A document provides answers to questions in the following areas:

–              Quality Management

–              Personnel

–              Buildings and Facilities – Containment

–              Process Equipment – Cleaning

–              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

–              Rejection and Reuse of Materials

–              Complaints and Recalls

–              Contract Manufacturer’s (including Laboratories)

–              Agents, Brokers, Traders, Distributors, Repackers, and Relabelers

–              Specific Guidance for APIs Manufactured by Cell Culture/Fermentation

–              APIs for Use in Clinical Trials


To add to the utility of the current Q & A document, it contains a table as an Annex to the document that illustrates the link between each Q & A in the current document with the corresponding sections of the original ICH Q7A document.

For further information or questions relating to any aspect of Good Manufacturing Practices for Active Pharmaceutical Ingredients or technical issues related to API development and manufacturing, please contact James Davidson, Ph.D. at