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ICH working to clarify Q7 for regulators

By Gareth MacDonald+

13-Nov-2012
Last updated on 13-Nov-2012 at 10:02 GMT

The ICH says regulator uncertainty over Q7 for ingredient supply chains, contractor management and quality management systems must be resolved.

The International Conference on Harmonisation (ICH) made the comments in a recent concept paper that examined how well the guidelines for good manufacturing practices (GMP) for active pharmaceutical ingredient (API) are being used by regulators.

It said that while the ICH Q7 guideline has been implemented successfully by the World Health Organisation (WHO) and other authorities around the world, there are still uncertainties related to some sections.

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."

With this in mind the organisation is conducting and preparing a guidance document. Topics include application of the principals to supply chain control, management of contractors and suppliers and impurity monitoring and production quality systems.

The ICH is also looking at the applicability of Q7 to biologic drugs, specifically how it works alongside the Q5D guideline on quality and its exceptions related to development-stage manufacturing for clinical trials.  

Q7 training for industry and regulators

The ICH’s efforts come a few weeks after the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operations Scheme (PIC/S) held its first inspector Q7 training session at a Parenteral Drug Association (PDA) event in Beijing, China.

At the time the PIC/S said it developed the programme in response to “requests from several national drug regulatory agencies” explaining that it covers “interpretation of ICH Q7 for industry and regulators, and training on API inspection, focusing on improving the skills and sharing approaches for addressing contemporary issues, for regulators only.”

The ICH acknowledged the work and said: “Output from the review of existing Q&As currently underway by PIC/S teams will be considered for endorsement.”

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