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ICH Q13: Continuous Manufacturing of Drug Substances and Drug Products

Updated: 15 November 2018

Continuous manufacturing can improve manufacturing of drug products and drug substances. However, its commercialization is challenging due to insufficient regulatory guidelines. Therefore, development of ICH guideline could support in minimizing such barriers. This can help in development of common regulatory concepts, definitions, processes, etc. Q13 final concept paper regarding continuous manufacturing was enforced Dated 15 November 2018. The new guideline will address regulatory expectations such as site implementation, post-approval changes and quality systems.

Major regulatory and technical considerations specific to continuous manufacturing cGMP elements, supervision regarding the development, implementation and evaluation of continuous manufacturing technologies will be included in ICH Q13 guideline. This guideline will be developed following the knowledge related to continuous manufacturing and scientific approaches. Expert working group will include industry and regulatory representatives having innovative thinking and who possess experience in regulatory and technical aspects related with continuous manufacturing.

Guideline completion anticipation time is 3 years. The development of ICH guideline would support in harmonizing the regulatory expectations and enhance regulatory assessment consistency.