FDA draft guidance – Continuous Manufacturing

The FDA published today a new draft guidance “Quality Considerations for Continuous Manufacturing Guidance for Industry.” Which, together with ICH plans continues to demonstrate the emphasis on continuous manufacturing.

More a set of questions than anything else, this is a good document for those who are grappling with the challenges of continuous manufacturing.

Q13 and Q14 path forward

Final concept papers have been published for the next two ICH quality guidelines. In both cases we can hope to see drafts in the first half of 2020. Both guidelines are intended to supplement the existing documents ICH Q8 – ICH Q12, reinforcing the principles of a risk based quality by design (QbD).

ICH Q13: Continuous Manufacturing of Drug Substances and Drug Products

Final concept paper and business plan. This new quality guideline will:

  • capture key technical and regulatory considerations including certain CGMP elements specific to continuous manufacturing
  • allow drug manufacturers to employ flexible approaches to develop, implement, or integrate continuous manufacturing for the manufacture of small molecules and therapeutic proteins for new and existing products
  • provide guidance to industry and regulatory agencies regarding regulatory expectations on the development, implementation, and assessment of continuous manufacturing technologies.

ICH Q2/Q14: Analytical Procedure Development

Concept paper and business plan. Q14 will bring the QbD principles to analytical development.

In the course of the preparation of this new guideline, ICH Q2 (Validation of Analytical Procedures) will also be revised. It will be adapted to the state of the art to include modern analytical methods in the future..

It’s stated that the Expert Working Group (EWG) will evaluate combining Q2 and Q14 into one document. Here’s hoping.