Quality Systems

Dec 10, 2018
By Pharmaceutical Technology Editors
FDA has approved Truxima (rituximab-abbs), a biosimilar to Roche’s anti-cancer biologic, Rituxan (rituximab).
Dec 05, 2018
Pharmaceutical Technology's In the Lab eNewsletter
Integration of two separate chromatography data systems boosts workflow efficiency.
Dec 03, 2018
The proposal from the Centers for Medicare and Medicaid Services (CMS) proposes to give plans more flexibility to limit coverage of certain drugs.
Dec 02, 2018
Pharmaceutical Technology
Once described as “throwing processes over the wall,” tech transfer is evolving into close collaboration and communication, as potential problems are considered sooner, and new technology is applied. Joseph Szczesiul, director of technical services for UPM Pharmaceuticals, shares best practices.
Dec 02, 2018
Pharmaceutical Technology
Simplified role-based training can lead to better quality metrics and compliance.
Dec 02, 2018
Pharmaceutical Technology
Success depends on supplier communication and transparency, but it’s up to buyers to demand the right information and to look at the vendor’s overall business goals.
Dec 02, 2018
Pharmaceutical Technology
Bio/pharma companies cannot spell success without solving all elements of quality programs.
Dec 02, 2018
Pharmaceutical Technology
Microbial identity data can be critical for determining contamination sources.
Dec 02, 2018
Pharmaceutical Technology
A required time frame should not be the driving force behind root cause investigations, says Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates.
Dec 01, 2018
Unprocessed bulk material harvested directly from the bioreactor should be tested for contamination prior to downstream processing.
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