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CDER has restricted information about API suppliers for products which never will need an authorised application from FDA being promoted, including compounded and OTC monograph medicines. API suppliers for this kind of items may not register their facility with FDA When they are sending content to y

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The validation protocol is published in advance of conducting validation actions. It should be organized through the validation group and approved from the worried Section. The objective of a validation protocol should be to define the exam scripts that needs to be adopted to ensure the processes an