Quality by Design, Validation, and PAT: operational, statistical, and engineering perspectives

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Quality by Design, Validation, and PAT: operational, statistical, and engineering perspectives

publication date: Aug 4, 2008

Dr. Janet Woodcock’s exhortation (ISPE Annual Meeting, 7 November 2005) that 21st century life science manufacturers should be ‘maximally efficient, agile and flexible’ and produce high quality drug products ‘without extensive regulatory oversight’ has been widely reported as a wake-up call to our industry.

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Quality by Design, Validation, and PAT: operational, statistical, and engineering perspectives