Quality Systems

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.
Jun 04, 2018
By BioPharm International Editors
The company is recalling two lots of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system due to particulate matter on the syringe plunger.
Jun 04, 2018
By BioPharm International Editors
EMA has recommended marketing authorization for Aimovig (erenumab), a new treatment for migraine.
Jun 04, 2018
By BioPharm International Editors
The FDA commissioner announced proposed steps to modernize the organization and functions of CDER’s Office of New Drugs.
Jun 01, 2018
BioPharm International
Higher cell titers and cell densities have posed a challenge to cell harvesting, a crucial step in biologics manufacturing.
Jun 01, 2018
BioPharm International
Aseptic fill/finish is crucial in biopharma manufacturing and is optimized through automated technology.
Jun 01, 2018
BioPharm International
FDA and Congress seek to limit the production and distribution of pain medicines.
Jun 01, 2018
BioPharm International
Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies.
Jun 01, 2018
BioPharm International
More advanced NGS-based techniques still require validation and regulatory acceptance.
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