US FDA adopts ICH Q11 on drug substance manufacturing

By Gareth Macdonald

- Last updated on GMT

Related tags Pharmaceutical drug Food and drug administration Fda

US FDA adopts Q11 on drug substance production
US FDA adopts Q11 on drug substance production
The US FDA has finally adopted the revised ICH Q11 guidelines on drug substance manufacturing nearly six months after European regulators embraced the guidelines.

The US Food and Drug Administration announced the decision in a note​ published in the Federal Register early today, explaining that Q11 will help firms understand active pharmaceutical ingredient (API) manufacturing processes and clarify what information they need to include in common technical documents (CTDs).

The document​ is a revised version of a draft guidance published in the Register last September. Changes include a stronger emphasis on the role purification processes play in API manufacture as well as revised recommendations on both design space and quality control strategies.

The FDA has had the guidance since May when the International Conference on Harmonisation (ICH) sent it to regulators around the world in an effort to harmonise the collection of regulatory data.

The idea is that harmonised CTDs will mean drugmakers no longer have to create multiple versions of documents when seeking marketing authorisations in regions covered by different drug watchdogs, which will reduce the time and resources then need to prepare applications.

The European Medicines Agency (EMA) was the first to move, adopting the guidelines this summer with the aim of implementing them fully before the end of the year.

The FDA’s uptake of Q11 means that Japan's Ministry of Health, Labor and Welfare (MHLW) is the last of the three regulatory bodies involved with the ICH to have taken a decision on the guidelines, or at least the last to have publicly announced a decision.

Clarification on harmonisation

The FDA’s adoption of Q11 follows just days after the ICH included the guideline on a list of documents it is working to clarify.

In a statement released last Tuesday​ the organisation said: “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​.”

The ICH is working on a clarified document that will include output from a separate review of Q&As being undertaken by the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operations Scheme (PIC/S), but did not say when the document will be available.

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