Four years after publishing a concept paper the International Conference on Harmonisation (ICH) has sent its Q11 guidelines to the three regulatory bodies. Adoption of Q11 will harmonise the collection of regulatory data on active pharmaceutical ingredients (API) and further evolution of production.
“This guideline describes approaches to developing and understanding the manufacturing process of the drug substance. It addresses aspects of development and manufacture that pertain to drug substance, including the presence of steps designed to reduce impurities”, the ICH wrote in Q11 .
Q11 builds on the three preceding ICH guidelines to clarify how the manufacturing principles relate to production of APIs. As such, terms like ‘design space’ and ‘quality risk management’, from ICH Q8 and Q9 respectively, are used throughout Q11 to support consistent, high quality production of APIs.
Part of the document is given over to detailing the information API manufacturers must include in the common technical documents they send to regulatory bodies. Harmonising CTDs will free firms from having to create several versions of documents when applying for marketing authorisations.
Ending this duplication of work will cut the time and resources taken to file marketing authorisations in different regions. The ICH decided against tackling requirements for post-approval changes in Q11, however.
Reaching consensus on other topics has taken time. Initial discussions about ICH Q11 began at least a year before the concept paper in 2008. Since then the ICH has reshaped the guidelines in response to meetings it held and 1000s of comments it received.