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USP is excited to share our first technical guide (TG) on PCM, focusing on solid oral drug product manufacturing control strategies.
As we all know, the concept of control strategy is well described in ICH Quality guidelines and used in several other publications. When it comes to Continuous Manufacturing, there are some special considerations even though the core concepts remain the same. In ICH Q13 we have covered those differences. However, a need for a deeper dive was felt. For instance:
What is and isn’t included in a PCM control strategy?
What is the role of critical process parameters, and how do you define those?
What role does process analytical technology play?
What about process modeling, risk analysis?
You get the picture.
So, we decided to develop this TG that starts from the very basics – and takes us through the journey.
The applications of PCM are broad and no single document can cover everything. So we have tried to be brief, yet attempted to provide an understanding of the complete process – limiting to solid oral drug product.
As we develop our future TGs, we will refer back to control strategy and go deeper into each topic, for example, material characterization, process modeling. We may even develop a similar TG for API manufacturing in the future.
I hope you all find this useful and most importantly, provide your feedback to us so we may improve the future version of this TG.
Atul Dubey @ on
USP is excited to share our first technical guide (TG) on PCM, focusing on solid oral drug product manufacturing control strategies.
As we all know, the concept of control strategy is well described in ICH Quality guidelines and used in several other publications. When it comes to Continuous Manufacturing, there are some special considerations even though the core concepts remain the same. In ICH Q13 we have covered those differences. However, a need for a deeper dive was felt. For instance:
You get the picture.
So, we decided to develop this TG that starts from the very basics – and takes us through the journey.
The applications of PCM are broad and no single document can cover everything. So we have tried to be brief, yet attempted to provide an understanding of the complete process – limiting to solid oral drug product.
As we develop our future TGs, we will refer back to control strategy and go deeper into each topic, for example, material characterization, process modeling. We may even develop a similar TG for API manufacturing in the future.
I hope you all find this useful and most importantly, provide your feedback to us so we may improve the future version of this TG.
The document can be accessed (for free!) by providing your email address into the form located here: Pharmaceutical Continuous Manufacturing: USP Technical Guide