The ICH assembly approved the topic of continuous production (CM) in June 2018 and an expert working group was formed. E International Council for the Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together regulators and the pharmaceutical industry to develop the ICH Guidelines.
The draft Q13 received the approval of step 2b and was released for public comment. Step 3 of the ICH process started on 27 July 2021. In Europe, the deadline for comments is 20 December 2021. Q13 is intended to apply to medicines / medicinal products and drug substances / APIs to chemical entities and therapeutic proteins. The principles may also apply to other biological and biotechnological entities. CM applies to new products and conversion of batch production to CM for existing products.
Section 2: Continuous Production Models
Section 2 of the draft guide describes three different CM models:
- A combination of approaches in which some unit operations operate in batch mode while others operate continuously
- An approach where all unit operations of a drug substance or drug product manufacturing processes are integrated and operate in a continuous manner
- An approach in which the drug substances and the operations of the drug product unit are integrated across the boundary between the drug substance and the drug product to form a single continuous production process
The draft uses Definition I Q7 a series for both the substance of the drug and the product of the drug. Based on this definition, the size of a series produced by CM can be determined in terms of one of the following:
- Quantity of output material
- Amount of input material
- Operating time at a specified mass flow rate
The batch size can also be defined as a range. Other approaches to batch sizing can be considered if scientifically justified.
Sections 3, 4 and 5
Section 3 of the draft guidelines covers scientific approaches, describing the development of the control strategy, changes in production output, and ongoing process verification.
Section 4 presents regulatory considerations, and section 5 is a glossary of key terms.
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