News about GMP/cGMP


ICH: ICH-Q13 Draft on Continuous Manufacturing released

ICH: ICH-Q13 Draft on Continuous Manufacturing released

On 27 July 2021, ICH published the anticipated draft of its Q13 Guideline on Continuous Manufacturing of Drug Substances & Drug Products. In Stage 2 of the ICH process the 44-page document has thus been released for public commentation.

The guideline is intended to provide "scientific and legal considerations for the design, implementation, operation and lifecycle management of continuous manufacturing (CM)".

In recent years, the use of smaller, modular plants in pharmaceutical manufacturing has steadily increased. The aim of ICH is to promote

  • harmonisation and thus alignment of CM concepts, especially elements specific to cGMP
  • to present different flexible approaches for development and implementation of CM
  • to provide guidance for industry and regulatory authorities for the assessment of CM-processes.

The document comprised of a guideline and five annexes addresses

  • the different methods of continuous manufacturing, including fully continuous and hybrid batch/flow systems,
  • regulatory aspects to be considered,
  • aspects of possible control strategies, and
  • examples of how to manage disturbances.

The guideline is applicable for continuous manufacturing of new products (e.g. new drugs, generics or biosimilars) as well as to conversion of batch manufacturing to CM of already existing products. The principles set out apply primarily to active substances and medicinal products, chemical compounds and therapeutic proteins. However, they can also be applied to other biological and biotechnological entities.

Released as Step 2 of the ICH process, the Q13 EWG draft guideline is now available for public comment & regional regulatory review. Evaluation of the comments is scheduled for November 2021.


ICH Q13: Continuous Manufacturing of Drug Substances and Drug Products

ICH: Quality Guidelines