Regulatory Focus™ > News Articles > FDA Announces Adoption of ICH's Q11 Manufacturing Guideline

FDA Announces Adoption of ICH's Q11 Manufacturing Guideline

Posted 19 November 2012 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has announced its adoption of the International Conference on Harmonization's Q11 guideline on the development and manufacture of biological and chemical drugs.

The guideline, Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological Biological Entities, was released by ICH on 1 May 2012 for voluntary adoption by worldwide regulators.

Explained FDA in its Federal Register posting announcing the guideline's adoption, "The guidance is intended to harmonize the scientific and technical principles relating to the description and justification of the development and manufacturing process of drug substances (both chemical entities and biotechnological/biological entities) to enable a consistent approach for providing and evaluating this information across the three regions."

"The discussion of principles in the guidance is intended to apply only to the manufacture of drug substance, not the manufacture of finished drug products," it added.

That harmonization of information primarily applies to the Common Technical Document (CTD), explained ICH in a May 2012 press statement. "[Q11] describes approaches to developing process and drug substance understanding and also provides guidance on what information should be provided" in the CTD, it wrote. The guideline also "provides further clarification on the principles and concepts described in ICH Guidelines on Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality Systems (Q10) as they pertain to the development and manufacture of drug substance."

FDA said three main changes should be noted in the updated Q11 guideline:

  1. revisions to the introduction and process development sections to more strongly emphasize that purification processes play a significant role in drug substance manufacture
  2. revisions to the discussion of design space for chemical entities and biotechnological/biological drug substances
  3. revisions to the discussion of control strategy 

Worldwide Adoption

At present, FDA, the European Medicines Agency (EMA) and Japan's Ministry of Health, Labor and Welfare (MHLW) are the three primary regulatory bodies involved in ICH, though others such as Canada use the standards on a voluntary and piecemeal basis.

EMA adopted the Q11 guideline shortly after its release (25 May 2012), and said final implementation would come sometime in November 2012. Regulatory Focus was unable to find any information regarding the adoption or impending adoption of Q11 in Japan.

The goal of global adoption of ICH's guidelines, explained FDA, is to seek the harmonization of scientifically based technical procedures for pharmaceutical development, which in turn makes it easier for both industry and regulators to accomplish their respective jobs. Industry gets more consistent requirements for submission, allowing it to spend less time reconfiguring applications to meet the various requirements of different countries. Regulators, meanwhile, receive more consistent applications that can be processed more quickly and effectively.

Tags: Q11, CTD, eCTD, development

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