New single-use technologies and other filtration systems are beginning to address cost, throughput, and manufacturing footprint demands.
Ensuring data integrity involves effort on an individual and global basis.
FDA’s proposed guidance for quality metrics raises questions about quantifying the tangibles and intangibles of quality culture.
Despite emergence of biologics, small-molecule APIs benefit from industry growth.
Pharma development and manufacturing firm Patheon announces new tagline and logo.
FDA announced the recall, citing deficiencies in Medistat’s aseptic processing areas and in its environmental monitoring procedures.
Suppliers indicate prices for single-use equipment are likely to increase.
The PDA report discusses qualification and operational handling of passive thermal protection systems.
The agency provides recommendations for submitting proposed labeling with abbreviated new drug applications.
The US Pharmacopeial Convention preposts its new chapter on sterile preparations for compounding pharmacies for public review.