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Quality systems model meets regulatory requirements
July 1, 2013
By: Tim Wright
Pillar5 Pharma, Inc. has passed an FDA cGMP inspection of its facility conducted the week of May 27, 2013. No 483’s were issued. The focus was to ensure implementation of modern quality systems and risk management approaches to meet cGMP regulations. This inspection was based on the comprehensive quality systems (QS) model for regulatory requirements for manufacturing human and veterinary drugs. The QS model addresses quality, production, facilities and equipment, laboratory controls, materials, packaging and labeling.
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