BioPhorum’s expert feedback on the FDA’s ICH Q12 guideline

newsNov 1, 2021 | News | Phorum : Regulatory


The globalization of the supply chain and market for medicinal products are complex areas. They have resulted in a growing number of different procedures, rules and country by country regulations that must be followed whenever post-approval changes to chemistry, manufacturing and controls (CMC) are proposed for various reasons. These regulations can stifle innovation and process improvements that ultimately benefit the patients.

ICH guidance Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management provides a framework to facilitate the management of such post-approval CMC changes predictably and efficiently across the product lifecycle. 

In response, the FDA has drafted a guideline ICH Q12: Implementation Considerations for FDA-Regulated Products Guidance for Industry and asked for industry comments.

Gathering a team of CMC biopharmaceutical experts, BioPhorum has now published Industry feedback on ICH Q12: Implementation Considerations for FDA-Regulated Products.

This contains general feedback that applies throughout the FDA document for the following areas:

  • Simplification
  • Scope and definition of established conditions
  • Application of established conditions
  • References used to drive harmonization of existing standards
  • Marketing applications with no registered established conditions
  • Reporting categories for changes to established conditions.

“Implementing ICH Q12 and especially its acceptance by all ICH members will create greater efficiency for post-approval changes,” said Mareike Viebahn, Manager Global CMC RA at Janssen Biologics, and one of the authors of the BioPhorum feedback.

“I personally like the post-approval management protocols, which would give us more security about complex changes and might also reduce country-specific requirements,” Viebahn added. “The most confusing elements in the ICH Q12 guideline and the FDA guidance document are the Established Conditions. I hope that with the new guideline, the post-approval change submissions will be harmonized between all ICH member states.”

The document also contains a detailed, line-by-line commentary on the FDA guideline and provides comments such as the need for clarification of the agency’s expectations, additional references to current legislation and the need to include mention of the risk-based paradigm for assessment of the potential impact of a change on product quality.

Veda Walcott, VP, Global Regulatory Affairs and Compliance for Catalent said, “The ICH Q12 guideline has potential to improve product and process knowledge and ease the post-approval change management burden for products manufactured for multiple markets. The collective challenge for regulators and industry will be achieving full alignment on established conditions so the benefits can be realized.”  BioPhorum commends the agency on this initiative and is delighted to contribute to such a critical discussion.

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