Pharma is generally viewed as having the most stringent regulatory requirements of any industry. Maintaining compliance with those requirements dominates manufacturing quality systems within pharma companies and their external production partners. In particular, regulations defining current good manufacturing practices (cGMPs) began taking shape in the mid-1970s and continue to evolve. However, significant changes to the manufacturing supply chain in the interim raise a critical question: Are the prevailing cGMPs sufficient to ensure companies are consistently manufacturing quality product? Click Here For Complete Article Text
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