Procedure of OOS

As per OOS guideline who will assign the fate of batch?

QA is responsible for the final decision of batch disposition.

As per FDA guiadance for industry: Investigating Out-ofSpecification (OOS) Test Results for Pharmaceutical Production, the Quality Unit is the one responsible to make the decision to either release or reject a batch.

Here is an extract of this guidance:

To conclude the investigation, the results should be evaluated, the batch quality should be
determined, and a release decision should be made by the QU. The relevant SOPs should be
followed in arriving at this point. Once a batch has been rejected, there is no limit to further
testing to determine the cause of the failure so that a corrective action can be taken

I hope this was helpful.

I have written in my previous communication, that the QA is responsible for the final decision on batch disposition. (Means whether to release or reject the batch under ‘OOS- Investigation’.

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Yes! Sorry, I wrote this reply 20 days ago, but mods have just approved it. It seems whenever you post a link in the post, it prevents the reply to be posted until a mod approves it. In this case it took them 20 days, and have otherstill pending for approval :confused: I gues I’ll have to stop posting links to references to prevent this from happening again.

Out-of-Specification (OOS): Investigate, document, and report deviations. Follow a systematic procedure to identify root causes, ensuring compliance and resolution.