Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

​When writing a CTD/eCTD Module 2 Quality Overall Summary (QOS), how much information/detail do you put in the 2.3.S.4.2 Analytical Procedures and 2.3.S.4.3 Validation of Analytical Procedures sections?  In the past, I have put the actual test method documents and associated validation reports in the respective Module 3 sections and added information for any non-compendial (in-house) test methods and associated validation information in tabulated form in the Module 2 QOS.  Tabulating all of the test method and validation details/information in the QOS just seems like overkill. 

What level of information/detail is to be included in these sections of the QOS?  What does the FDA want to see?  What do you do? 

I would appreciate some input on this topic.  Thank you very much.

​I have seen different approaches at different companies, but in both cases very little information is provided.

At one company, we listed the methods in a table with a very high-level description of the principle of the method provided. This was back when the CTD was first introduced, and I have since left that company, so I can't say whether that is still their practice.

In my more recent experience, basically no information is given and they just refer to Module 3 for the full descriptions.

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Rachel Thornton
Associate Director
Smyrna GA
United States
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Original Message:
Sent: 05-Dec-2018 09:39
From: Anonymous Member
Subject: Module 2 QOS

This message was posted by a user wishing to remain anonymous

​When writing a CTD/eCTD Module 2 Quality Overall Summary (QOS), how much information/detail do you put in the 2.3.S.4.2 Analytical Procedures and 2.3.S.4.3 Validation of Analytical Procedures sections?  In the past, I have put the actual test method documents and associated validation reports in the respective Module 3 sections and added information for any non-compendial (in-house) test methods and associated validation information in tabulated form in the Module 2 QOS.  Tabulating all of the test method and validation details/information in the QOS just seems like overkill.

What level of information/detail is to be included in these sections of the QOS?  What does the FDA want to see?  What do you do?

I would appreciate some input on this topic.  Thank you very much.

I agree with your approach. In my experience we typically refer to a DMF for the drug substance information,  But for drug product I take a similar approach as you describe.  A brief summary (ex. 1 paragraph) for each method or validation in the QOS with a link to the full method or validation report in 32P52/32P53.

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Tom
Chicago
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Original Message:
Sent: 05-Dec-2018 09:39
From: Anonymous Member
Subject: Module 2 QOS

This message was posted by a user wishing to remain anonymous

​When writing a CTD/eCTD Module 2 Quality Overall Summary (QOS), how much information/detail do you put in the 2.3.S.4.2 Analytical Procedures and 2.3.S.4.3 Validation of Analytical Procedures sections?  In the past, I have put the actual test method documents and associated validation reports in the respective Module 3 sections and added information for any non-compendial (in-house) test methods and associated validation information in tabulated form in the Module 2 QOS.  Tabulating all of the test method and validation details/information in the QOS just seems like overkill.

What level of information/detail is to be included in these sections of the QOS?  What does the FDA want to see?  What do you do?

I would appreciate some input on this topic.  Thank you very much.