Challenges in Securing the Biopharma Supply Chain
Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals.
Wolfgang Weikmann of Vetter Pharma discusses the implementation of quality by design in sterile manufacturing.
BioPharm International speaks with industry experts about challenges faced in managing the cold chain.
Industry experts discuss the implementation of QbD and PAT tools in biopharmaceutical manufacturing.
FDA inspections of compounding pharmacies manufacturing sterile-drug products lead to voluntary recalls.
FDA's FY 2014 budget includes more than $10 million above the 2012 budget for inspections of products and ingredients manufactured in China.
FDA inspections of compounding pharmacies result in FDA-483 citations.
BioPharm International spoke with industry experts about the effect FDA's 2011 process validation guidance has had on industry.