An Update on the Quality Metrics Initiative

In 2005, the FDA wanted “a maximally efficient, agile, flexible, pharmaceutical manufacturing sector that reliably produces high quality drug products without extensive regulatory oversight.” More than 10 years later, how far has the FDA come to establishing these metrics? Susan Schniepp, Distinguished Fellow of Regulatory Compliance Associates® Inc., offers her insight and expertise on this subject.

 

Complete article published in BioPharm International.

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