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“The adoption of advanced production systems might pose a challenge to The present regulatory framework since most polices were formulated depending on conventional batch manufacturing strategies underneath a unified pharmaceutical good quality method,” defined Woodcock in her testimony.

(one) Sample measurement and take a look at intervals based on statistical conditions for every attribute examined to assure valid estimates of security; (e) Returned labeling shall be managed and stored within a fashion to avoid mixups and provide appropriate identification. The IAG can refus

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