International – ICH adopts Q13 guideline on continuous manufacturing

The International Council for Harmonisation (ICH) has adopted its guideline on continuous manufacturing (CM), in a nod to embracing more modern modes of manufacturing. In the final version of guidance, ICH acceded to industry’s request to clarify state of control and process dynamics.

ICH in late November had announced the adoption of the Q13 guidance but the document was not yet released. (RELATED: ICH touts adoption of continuous manufacturing, safety reporting guidelines, Regulatory Focus 22 November 2022).

In the US, Food and Drug Administration (FDA) officials have been encouraging manufacturers to switch to continuous manufacturing from the more antiquated batch production process for years to improve product quality, minimize product defects and reduce shortages.

Results from a recent FDA audit showed that continuous manufacturing applicants saw quicker approvals and higher revenue than applications relying on batch manufacturing processes. (RELATED: Continuous manufacturing applicants saw quicker approvals, higher revenue than batch applicationsRegulatory Focus 6 July 2022)…