Hi Alaa,
I agree with Tom, if spec changes have little to no impact on analytical testing regiment, then making a global spec change covering all regions to harmonize your file would reduce your post-approval lifecycle management burden. If there will be an impact, then you'll need to manage individual variations of your spec for each region. If you're testing a batch that will be sent to different regions, you could test according to the tightest spec and do any additional testing that is specific to certain regions only.
Managing post-approval changes covering multiple regions is always going to be a challenge and will require a robust change management system and good regulatory and QA folks to assess the impact of those changes - and to implement them. Good luck!
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Emily Kong, MS, RAC
Associate Director, Regulatory Affairs, CMC
South San Francisco, CA
United States
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Original Message:
Sent: 09-Mar-2021 11:32
From: Tom Stothoff
Subject: Drugs CMC changes roll-out in multiple regions
I haven't been involved in a project like this for a while, but from prior experience you ideally want to get the change approved in all regions prior to implementing. If an authority requires a change to a specification you'll have to evaluate whether you want to incorporate that change for all regions in order to keep the specification the same vs just the country that requested the change and have to manage multiple specifications. I always kept a spreadsheet that listed the versions of each Module 3 document that was submitted/approved in each region. Documents included a date and code in header or footer for tracking purposes.
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Tom Stothoff
Senior Director, Regulatory Affairs CMC
Chicago
Original Message:
Sent: 08-Mar-2021 15:02
From: Alaa El Kazak
Subject: Drugs CMC changes roll-out in multiple regions
Dear drugs CMC folks,
I think it's very challenging to plan and implement CMC post-approval changes in multiple regions.
What is your advice to set an efficient strategy for the change roll-out?
Also, How to handle the discrepancies that may rise in the different authorities inquires? For example, one authority may insist on making a change in the finished product specifications while another doesn't? How these differences are handled internally for batch control testing when the same batch will be sent to different regions?
Thanks in advance.
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Alaa El Kazak Msc., RAC
Jeddah
Saudi Arabia
https://www.linkedin.com/in/alaaelkazak/
http://bcert.me/snztdjygk
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