Quality Systems

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Regulatory authorities have published draft guidance on strategies to facilitate pharmaceutical lifecycle management.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.
Jun 06, 2018
By BioPharm International Editors
The International Society of Pharmaceutical Engineering (ISPE) is field-testing the design principles of a comprehensive, industry-led program of self-evaluation of pharmaceutical quality that will align with the purpose of FDA’s quality metrics.
Jun 04, 2018
By BioPharm International Editors
The agency has recommended approval of three biosimilar adalimumab products from Novartis, referencing AbbVie’s Humira, and a biosimilar trastuzumab from Pfizer, referencing Roche’s Herceptin.
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