Quality Systems

Jun 22, 2018
By BioPharm International Editors
The agency published guidance about requests for Prescription Drug User Fee Act waivers, refunds, and reductions in user fees.
Jun 21, 2018
By BioPharm International Editors
The contract development and manufacturing company has received an additional approval from Health Canada to manufacture monoclonal antibody drug substance at its first plant in Icheon, South Korea.
Jun 20, 2018
Legislators have requested that FDA do more to prevent drug shortages.
Jun 15, 2018
BioPharm International
Single-use technologies have become increasingly prevalent in final fill/finish operations for biologics.
Jun 15, 2018
BioPharm International
Biosimilars and biobetters have their own unique manufacturing strategies and challenges.
Jun 15, 2018
BioPharm International
Industry experts discuss how to address extractables and leachables in single-use systems and the challenges in qualifying equipment.
Jun 15, 2018
BioPharm International
An understanding of the unique nature of single-use systems, and how they interact with each biomanufacturing process, is important when qualifying single-use systems.
Jun 08, 2018
Regulatory authorities have published draft guidance on strategies to facilitate pharmaceutical lifecycle management.
Jun 07, 2018
By BioPharm International Editors
The company will provide the first FlexFactory manufacturing platform for TCR T-cell therapy manufacturing.
Jun 07, 2018
The agency is encouraging team-based reviews and streamlined processes that will make the oversight process more efficient and consistent.
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