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October 02, 2012
Managing risk in biopharmaceutical operations is of utmost importance for patient protection.
The authors describe how traditional approaches to analytical method and validation may benefit from alignment with quality-by-design concepts.
This study examines the effect and interaction of variations in hypromellose physicochemical properties.
Working together affords many unseen opportunities for pharmaceutical innovation.
September 04, 2012
Bristol-Myers Squibb has initiated a voluntary recall of 10 lots of BiCNU (carmustine for injection) previously manufactured by Ben Venue Laboratories, a former, third-party contract manufacturer for the company, to the user level.
September 02, 2012
PDA's strategic plan calls for maintaining valuable and effective relationships with global regulators.
MIT survey results address product and site characteristics that statistically correlate with quality performance.
August 02, 2012
The author discusses strategies for preventing cargo theft.
August 01, 2012
The author discusses how a CDMO helps in gaining process understanding and in developing robust, high-quality products and processes.
July 09, 2012
ISPE has issued a guidance that is intended to help companies meet cGMP requirements for packaging, labeling, and warehousing facilities and avoid problems such as product adulteration, product mix-up, label mix-up, and misbranding.