FDA announces availability of draft guidance on continuous manufacturing

The FDA is announcing the availability of a draft ICH guidance for industry titled “Q13 Continuous Manufacturing of Drug Substances and Drug Products.” The guidance, which was prepared under the support of the International Council for Harmonisation (ICH), describes scientific and regulatory considerations for the development, implementation, and operation of continuous manufacturing.

ICH Q13, endorsed by the ICH Assembly in June 2021, applies to continuous manufacturing of drug substances and drug products for chemical entities and therapeutic proteins. The guidance is applicable to new products (e.g., new drugs, generic drugs, biosimilars) and the conversion of existing products using batch manufacturing to continuous manufacturing. The principles described in this guidance may also apply to other biological/biotechnological entities. This guidance builds on existing ICH Quality guidelines, including ICH Q7 through Q10.

FDA has long supported continuous manufacturing and has taken proactive steps to facilitate the pharmaceutical industry’s implementation of continuous manufacturing and other emerging technologies that improve product quality and address many of the underlying causes of drug shortages and recalls. This new ICH guidance provides global harmonization for continuous manufacturing regulatory approaches and encourages broader adoption of this technology. Continuous manufacturing is an important technology because it:

  • eliminates manual handling and human error,
  • increases quality assurance through online monitoring and control,
  • reduces manufacturing time and increases efficiency,
  • reduces capital costs by using smaller equipment and less manufacturing space,
  • responds more nimbly in the event of a drug shortage, and
  • allows manufacturers to tailor drug production to fit the needs of precision medicine. 

For additional information on FDA’s efforts related to continuous manufacturing and advanced manufacturing, read FDA’s Advanced Manufacturing Initiatives Helping to Provide Quality Human Drugs for Patients or visit FDA’s Center for Drug Evaluation and Research Emerging Technology Program and Center for Biologics Evaluation and Research CBER Advanced Technologies Team webpages.

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