The new ICH Q13 guideline is almost here! The guideline on continuous manufacturing (CM) is currently under public consultation and the general deadline for comments is end of 2021.

We, as 4TE, have been actively involved on the public consultation phase. And, because of that, we thought of talking a bit about it.

What is the timeline?

The final version of ICH Q13 arrives in November 2022.

What will be in it?

The guideline covers several points all connected to Continuous Manufacturing. Specifically, it looks at the scientific and regulatory perspective for the development, implementation and lifecycle management of drug substances and drug products.

And it also does this from two perspectives: new products and the transition of existing products from batch to CM.

A much needed clarification

This guideline is so important because it bring a much needed clarification to CM. And what does it clarify?

First of all, it specifies the different CM modes. That is, the difference between Hybrid, CM or integrated CM modes of setting up production.

It bridges the batch definition of ICH Q7 by providing advice on control strategy, production output and continuous process verification.

The guideline also supports the process description by complementing the ICH M4Q so that it covers CM processes.

It covers Control strategy with relevant controls and approaches used during manufacturing.

Last, but not the least, it also covers both batch description and the conversion of a batch process into CM.

A handful of supplements

The guideline is not only full of the important information we pointed before. It also includes a set of annexes that cover:

  • DS for chemical entities
  • DP
  • Therapeutic Protein DS
  • Integrated DP and DS
  • Perspectives on managing disturbances

Would you like to know more on the subject?

If you’d like to know more about the new ICH Q13 Guideline, look no further! We have just published a deeper article on the subject which you can get here.

Additionally, we have written a few pieces on Continuous Manufacturing such as:

Can we help your CM transformation?

Our team is specialized in delivering Continuous Manufacturing Implementation and Support. If you’d like to move towards the benefits of Continuous Manufacturing, take a look at our services