In-Process and Bulk Drug Product Holding Times

Quality Assurance
1

Hello everyone
Can you direct me to the official text of the FDA which talks about the validation of holding times (In-Process and Bulk Drug Product Holding Times) especially for suspensions thank you.

2

Hi, I’m not sure if FDA has an official guidance where it talks specifically about it, but the CFR clearly states so in its section 211.111, as a direct regulatory requirement:

211.111 Time limitations on production

I hope this is helpful!

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3

thank you :slight_smile: @Andmentor
it is about a coating suspension do you know any other text this one is very vague thanks again @Andmentor

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4

Here is a guideline by WHO - Annex 4
General guidance on hold-time studies: TRS 992. Annexure 4 (with an example of coated and uncoated tablets Hold time- study is explained).

https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/WHO_TRS_992_web.pdf

Hope this will suffice your requirement.

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5

Oh, I see; I’m sorry, I do not know of any FDA offitial guideline about hold time validation; however, WHO (World Health Organization) has a guidance type document for hold time studies, it is QAS/13.521. Last I saw it was a draft, but should have been released by now.

I remember seeing in that document which stages and for what processes should hold time studies be performed, though I don’t remember how much information is given on how to perform it; however, I do remmber it addressing the coating and also the binder solution to be considered for such studies.

Sorry for not directing you to an official FDA guideline, but perhaps it is useful.

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6

Oh thanks @sunilrbudhkar ! I did not see your post. This is better.

7

Sir, you are always welcome.

8

thanks a lot @sunilrbudhkar

9

thank you very much for your answer @Andmentor .

10

You are always welcome.

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