Revalidation-Extent / level of evaluation

Dear All,

As we know that :
Any significant change to the system/processing equipment / process / services /Utelities triggers revalidation such as :
Change in source of API or major component /
Change in batch size
formula change,
trends of stability data,
trends of annual product review
or any other changes that may affect the product quality

So, how to evaluate the extent or the level of defining as term “significant” in these above situations?
cite with examples?
Also, How the validation need , evolves out risk assessment?and in all cases we need to extraploate Risk assessment.


Please read EMA/Eudralex guidelines on Variations and Changes in manufacturing processes and GMP environment post Approval of Regulatory filing of product dossiers in European countries. Also read USFDA guidelines on Scale up and post Approval changes (SUPAC) to understand categories of the changes or variations as Critical, Major and minor. And extent to which re-validation is required to be performed based on nature of changes and reported to the Regulatory agencies has been defined.

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Hello Sunil

The current issue of monograph is EP has deleted heavy metals test from API monographs but implimented elementary limits test but the issue is that it is declared on the webpage of EDQM but this notice is not available in the monograph books.

So, can anyone please tell me where in EP monograph it apparently said that Heavy Metals test should be deleted but Elementary limits test should be implimented.

But about in USP it’s clearly explained in chapter 232 & 233.

All my concerned n questions is about EP

I suggest you can write to EDQM this specific matter and get the issue clarified, because EP may not specify this.