Process Validation: As described in the FDA & EMA guidelines on process validation, it's a continuous process that should be ongoing through the clinical phases, culminating in process performance qualification of your commercial process, and followed by continuous process verification after approval. For most markets, there is no expectation that any PPQ data would be submitted in a clinical trial application but is required in the marketing application. However, there is a strong preference for the commercial process to be used in your Ph3 trials, so PPQ is often performed just before or in parallel with Ph3. Even though the PPQ data is not required, many agencies want to see discussion of critical controls, particularly at Ph3. Also, validation of sterile or aseptic processes, or any non-standard processes, is required.
Method Validation: Full method validation, in line with ICH guidance, is required in the marketing application. Earlier in development you should have some sort of qualification, if not full validation, just to be sure that you can trust the data your methods are giving you. A summary of that data should be included in the CTA. It's generally a good idea to have your methods fully validated before Ph3, and definitely before you run your PPQ batches, just because it's a huge risk to the company if you later find out that the method you used to generate all your Quality data is unreliable.
The EMA guideline on requirements for the Quality information for a biotechnology product in the IMPD gives a good indication of what is expected when.
Does that answer your question?
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Rachel Thornton
Associate Director
Smyrna GA
United States
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Original Message:
Sent: 18-Oct-2020 11:13
From: Meena Garg
Subject: Qualification/ Validation
Hello Jingdong,
Please clarify, 1) are you seeking guidance for validation of manufacturing process or analytical procedures or both? Yes
2) biologics (I assume you refer to drugs not devices, right?), advanced therapies (e.g., gene and cellular therapeutics) vs proteins (E.g., mAbs, enzymes and cytokines) or both? Yes, Including vaccines, not devices.
Many thanks
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Meena Garg
Regulatory and QA Consultant, Vaccines
Brampton ON
Canada
Original Message:
Sent: 18-Oct-2020 10:18
From: Jingdong Zhu
Subject: Qualification/ Validation
Hi Meena,
Please clarify, 1) are you seeking guidance for validation of manufacturing process or analytical procedures or both? 2) biologics (I assume you refer to drugs not devices, right?), advanced therapies (e.g., gene and cellular therapeutics) vs proteins (E.g., mAbs, enzymes and cytokines) or both?
Sent from my iPhone
Original Message:
Sent: 10/17/2020 7:44:00 AM
From: Meena Garg
Subject: RE: Qualification/ Validation
To be specific, request is for biologics.
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Meena Garg
Regulatory and QA Consultant, Vaccines
Brampton ON
Canada
Original Message:
Sent: 17-Oct-2020 07:40
From: Meena Garg
Subject: Qualification/ Validation
I am looking for guidance on appropriate level of qualification/ validation through different phases of Clinical Trials Phase1, 2, 3 and 4.
Your expert advice is appreciated.
Thank you.
Sent from my iPhone