The International Council for Harmonisation (ICH) has published its draft Q13 guideline on continuous manufacturing of drug substances and drug products, for consultation.
Perceived problem necessitating this guideline
- According to the ICH Concept paper of November 2018, there is a general consensus that continuous manufacturing (CM) has potential for improving the efficiency, agility, and flexibility of drug substance and drug product manufacturing.
- Regulatory agencies have seen more companies engaged in the development and implementation of CM in recent years than in the past.
- Although current regulatory frameworks allow for commercialization of products using CM technology, a lack of regulatory guidelines can make implementation, regulatory approval, and lifecycle management challenging, particularly for products intended for commercialisation internationally.
- An ICH guideline would facilitate international harmonisation and could reduce barriers to the adoption of CM technology.
About the guideline
The draft guideline is a 44 page document with five annexes as follows:
- Annex I – Continuous manufacturing of drug substances
- Annex II -Continuous manufacturing for drug products
- Annex III -Continuous manufacturingof therapeutic drug protein substances
- Annex IV – concerns integrated drug substance and drug product continuous manufacturing. It includes the location of drug substance and drug product information in the CTD.
- Annex V – Perspectives on managing disturbances
What are the objectives of the guideline?
This guideline describes scientific and regulatory considerations for the :
- development
- implementation
- operation and
- lifecycle management of continuous manufacturing (CM).
Building on existing ICH Quality guidelines, it provides clarification on CM concepts, describes scientific approaches, and presents regulatory considerations specific to CM of drug substances and drug products.
How is the guideline expected to achieve its objectives?
It is expected to achieve its objectives by facilitating the following:
- Capture key technical and regulatory considerations that promote harmonisation, including certain Current Good Manufacturing Practices (CGMP) elements specific to Continuous Manufacturing (CM),
- Allow drug manufacturers to employ flexible approaches to develop, implement, or integrate CM for the manufacture – drug substances and drug products – of small molecules and therapeutic proteins for new and existing products,
- Provide guidance to industry and regulatory agencies regarding regulatory expectations on the development, implementation, and assessment of CM technologies used in the manufacture of drug substances and drug products.
What is the scope of this guideline?
This guideline applies to:
- CM of drug substances and drug products for chemical entities and therapeutic proteins.
- CM for new products (e.g., new drugs, generic drugs, biosimilars)
- conversion of batch manufacturing to CM for existing products.
The principles described in this guideline may also apply to other biological/biotechnological entities.
Steps of the guideline
| Date | Step | Description |
| May 2021 | 1 | Virtual EWG Meeting to finalize the technical document and Step 1 sign-of |
| June 2021 | 2 | Step 2 a/b endorsement and initiation of public consultation |
| July 2021 | – | Draft published for consultation |
| November 2022 | 3 and 4 | Step 3 sign-off and Step 4 adoption of final guideline |
Further information is available here on the steps/milestones of the guideline.
Source: ICH website