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October 05, 2016
The time and resources required to finalize post-approval changes may be preventing manufacturers from modernizing facilities, or even scouting for new technology.
September 21, 2016
Genentech’s biologics drug substance plant is the overall winner of the International Society for Pharmaceutical Engineering’s 2016 FOYA Awards.
September 02, 2016
Renovating a facility requires careful design and a plan to minimize production interruption.
Industry experts discuss recent trends in modular manufacturing.
September 01, 2016
FDA cites two Xinxiang Tuoxin Biochemical facilities with CGMP deviations.
August 02, 2016
Susan Schniepp, Distinguished Fellow at Regulatory Compliance Associates, discusses the regulatory requirements for improving manufacturing lines.
July 02, 2016
Integrating quality and compliance with technology transfer and careful project management are key in starting up a facility and launching a biologic drug.
June 02, 2016
Different types of modular systems have advantages and disadvantages.
This article presents recommendations based on a program that was set up to qualify members of a large, diverse team at one oral solid-dosage-form manufacturing facility.
May 15, 2016
This article examines the changes now taking place, and what the future might bring.