FDA Final Guidance: ICH Q13 Continuous Manufacturing of Drug Substances and Drug Products

 For my CMC colleagues, if you follow ICH releasing new guidance, you may have already seen and are preparing for this guidance. With the FDA publishing it, compliance with its content is now expected in the US. 

The Objective and Scope provide clarity on what is being covered:

A. Objective (1.1)

This guidance describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM). Building on existing International Council for Harmonization (ICH) Quality guidances, this guidance provides clarification on CM concepts and describes scientific approaches and regulatory considerations specific to CM of drug substances and drug products. 

Pretty straight forward as to which phases (all) of continuous manufacturing are covered.

B. Scope (1.2)

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

Interesting here are several things:

1. Coverage of chemical drugs and therapeutic proteins, including generics and biosimilars

2. New processes or conversion of batch processes to continuous manufacturing

and perhaps the most impactful

3. "The principles described in this guidance may also apply to other biological/biotechnological entities."

This last item indicates that the ICH working group was forward looking to other therapeutic modalities (oligonucleotides, vaccines, gene therapy and perhaps cell therapies).  However, without specifically stating coverage, some confusion may arise if the guidance is to be applied or not. If you have questions, the FDA and other global regulatory groups are typically available to answer questions.

The guidance itself is only 18 pages, but several Annexes with examples follow to provide further interpretation of the guidance into real world situations. 

If you are in the CMC space, a recommended read.