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ICH-Quality Guidance: Q13 Continuous Manufacturing of Drug Substances and Drug Products

In today's FDA press release, the ICH final guidance titled "Q13 Continuous Manufacturing of Drug Substances and Drug Products" was released.

The guidance describes scientific and regulatory factors relating to Continuous Manufacturing (CM) development, implementation, operation, and lifecycle management, as well as clarifying CM concepts and describing scientific approaches and regulatory considerations specific to the CM of drugs.

CM involves the continuous feeding of input materials into, the transformation of in-process materials within, and the concomitant removal of output materials from a manufacturing process.

The scope applies to CM of drug substances and drug products for chemical entities, therapeutic proteins where it applies to new products (e.g., new drugs, generic drugs, biosimilars) and the conversion of existing products to batch manufacturing. The principles described in this guidance may also apply to other biological/ biotechnological entities.

One of the following parameters can be used to define the size of a batch created by CM:

  1. Quantity of output material

  2. Quantity of input material

  3. Run time at a defined mass flow rate

In addition, other approaches to batch size can be used if scientifically justified by the characteristics of the CM process and Good Manufacturing Practices.

Click this LINK to know more in detail about the Scientific approaches & the regulatory considerations that is involved in Q13 Continuous Manufacturing of Drug Substances and Drug Products.


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