The Management Committee of the ICH has endorsed the final concept paper and business plan on the new quality guideline ICH Q13 on continuous manufacturing for drug substances and drug products. Both documents are published on the ICH website.
The proposed new quality guideline shall
- harmonise CM-related definitions
- articulate key scientific approaches for CM, and
- harmonise regulatory concepts and expectations for CM across the regions.
According to the published business plan, the objectives of ICH Q13 are to
- capture key technical and regulatory considerations including certain CGMP elements specific to CM
- allow drug manufacturers to employ flexible approaches to develop, implement, or integrate CM for the manufacture of small molecules and therapeutic proteins for new and existing products, and
- provide guidance to industry and regulatory agencies regarding regulatory expectations on the development, implementation, and assessment of CM technologies.
An Expert Working Group with 35 experts has set a time frame from November 2018 – November 2021, to reach Step 4 of the ICH process. A step 2b document can be expected in June 2020.