The Office of Pharmaceutical Quality in the US Food and Drug Administration’s Center for Drug Evaluation and Research has instructed its staff to follow through on a legislative requirement to regard pharmaceutical manufacturing facilities more suspiciously if they are in countries where such facilities generally have relatively poor compliance histories.
US FDA To Increase Surveillance Of Pharmaceutical Manufacturing Sites In Poor-Quality Countries
Agency revises internal guidance to incorporate statutory requirement for greater scrutiny of drug manufacturing facilities in countries where past experience demonstrates overall quality is low. Revised MAPP also allows for inspection deferral at sites that have superior quality systems.
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