When changing the supplier for an excipient, it should be managed through a change control process. Generally, it should be initiated by the QA and evaluate for potential risks and impacts on product quality and compliance.
Planned deviations and temporary change controls involve managing deviations from standard procedures. I think most industries use temp Change to handle this, however it depends on time duration, purpose and scope.
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Sir change of supplier for excipients..means change control na ? Who should rise change control
When changing the supplier for an excipient, it should be managed through a change control process. Generally, it should be initiated by the QA and evaluate for potential risks and impacts on product quality and compliance.
Is planned deviation now considered as temporary change control ? Or is it still a different terminology
Planned deviations and temporary change controls involve managing deviations from standard procedures.
I think most industries use temp Change to handle this, however it depends on time duration, purpose and scope.
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Which guideline mentions about PLANNED DEVIATION...?Only WHO proposed for planned deviation...Please give the exact guideline reference..
Please check below
www.thefdagroup.com/blog/deviation-management
www.gmp-compliance.org/gmp-news/gmp-are-there-planned-deviations