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[RegAffairs]Re: Compliance with specification at the end of shelflife
For a European marketing authorisation application the information includes the release specification and the shelf life specification. The applicant would need to justify the omission of tests from the former in the latter. This is simpler for some tests - such as residual solvent - than for others. Regards, Brian Matthews. --------------------------------------- Government and Regulatory Bodies http://www.pharmweb.net/regulatory.html |
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