22/23 February 2024
The International Committee for Harmonisation (ICH) has published a concept paper on 17 October 2012. According to the announcement, the ICH Implementation Working Group (Q7 IWG) is currently working on a Q7 Question and Answer document.
The ICH Q7 Guide "GMP for APIs" (formerly known as ICH Q7A) is a harmonised Guideline in USA, Europe and Japan and was approved in November 2000. In the meantime, new quality concepts have been developed. Especially ICH Q8, Q9, Q10 and Q11 have influenced the interpretation of GMP significantly. Technical issues with regard to GMP of APIs – also in context with new ICH Guidelines - need to be addressed in order to harmonize expectations during inspections.
The ICH Working Group will consider the existing Q&A documents such as the PIC/S document for the development of the new ICH Q7 Q&A document. According to the concept paper, it has become apparent that certain individual implementation approaches are leading to non-harmonized interpretation and new expectations which go beyond the intention of ICH Q7. The first meeting of the IWG took place in November 2012. The step 2 and 4 documents are scheduled for 2014
The international training programme developed by APIC/CEFIC in co-operation with ECA has been adapted just recently. The agenda for the upcoming ICH Q7 Week in February 2013 has been adjusted to consider Q8, Q9, Q10 and Q11for the implementation of ICH Q7.
Source: Concept Paper Q7 Q&A