The International Conference on Harmonisation (ICH) has published a new concept paper regarding the standardized regulation of good manufacturing practices (GMPs) for active pharmaceutical ingredients (APIs), the first step in reforming the organization's Quality 7 (Q7) Guideline.
The paper, endorsed by ICH's Steering Committee in October 2012 and released in November 2012, refers to the widely-used Q7 GMP Guidance for APIs, released in November 2000. The document, ICH notes, "is implemented successfully in the regulatory framework by the World Health Organization (WHO) and most authorities around the world."
Despite its usefulness, it is in need to some updates to correct some ambiguities and maintain harmonization, wrote the Q7 working group in their concept paper.
"It has become apparent, based on the approval and implementation of ICH Q8, Q9, Q10, Q11 principles into GMP of APIs that certain individual implementation approaches are leading to non-harmonized interpretation and new expectations beyond the intention of ICH Q7."
The committee said several issues had been identified as requiring review, including supply chain control, outsource management, monitoring of impurity profiles, quality systems, the application of the guidance to biological medicines and biotechnology products, Q7's relationship to the Q5D Guideline on the Quality of Biotechnological Products, and expectations for manufacturing done specifically for clinical trials.
ICH also noted that other groups, including the Pharmaceutical Inspection Convention and Co-Operation Scheme (PIC/S), have already begun to review the Q7 guideline, and their recommendations could come to be "considered for endorsement" by ICH's working group.
Finally, ICH said it would study the implementation of itsQ8, Q9, Q10 and Q11 on Q7, and whether the overlap of the documents had inadvertently created disharmonization in any way or ways.
A working group will be formed to assess and make recommendations on the identified issues in the hopes of providing clarification and a way forward, ICH said.