In recent years, the use of smaller, modular plants in pharmaceutical manufacturing has steadily increased. The aim of ICH is to promote
The document comprised of a guideline and five annexes addresses
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: Quality Guidelines
> Do not hesitate, we look forward to your feedback!
Write a comment on this news.