Pharmacopeial Method Verification

Discussions about methods, troubleshooting and best practices across both pharmaceutical and biopharmaceutical analysis.

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When verifying a pharmacopeial method for material coming from a supplier, for example a Related substances pharmacopeial method and the material being supplied has an extra process impurity unique to that supplier, would that require a full validation to be done because of the extra impurity or would a 'verification' level of qualification still be sufficient?
You can amend you existing validation with justification. I dont think full validation is needed
2 posts Page 1 of 1

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