Closure of a deviation with a CAPA planned but not closed

Quality Assurance
1

Dear all,
can you suggest me if it is correct in a GMP QMS the closure of a deviation before that the CAPA are implementing?
Thank you

2

You shoukd not close the deviation untill CAPAs are closed. Only after ensuring by QA that all CAPA actions are satisfactorily implemented or followed only then that deviation should be closed. This should be governed by internal SOP.

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3

@Guid Your deviation (DV) is your investigation and impact assessment, the CAPA is your resultant actions. If you have finished investigating, assessing impact, and have defined and initiated all your CAPA; then you should close the DV regardless of the implementation status of your CAPA, as long as suitable CAPA have been initiated.

The implementation time of the resulting CAPAs should be realistic - it may take more than 6 months to fully implement some CAPA, which is a very long time to delay the release of your product if your investigation is complete found no impact to the Product quality from that particular DV.

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4

Many thanks

5

Sir lets suppose we have initiated deviation as a result of reprocessing of batch and are going to charge that batch on stability then in such case when should we close deviation @sunilrbudhkar @DrLandstr0m

6

You can close the deviation when reprocessing of that batch is satisfactorily completed, and QA has released that batch for distribution. A stability study will be an ongoing process.

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7

Thankyou sir for your valuable response.

Further can i ask for reference guidlelines regarding closure conditions/ timelines of deviation closure @sunilrbudhkar