Quality Systems

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 Pharmaceutical Technology 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 Pharmaceutical Technology Editors
EMA has recommended marketing authorization for Aimovig (erenumab), a new treatment for migraine.
Jun 04, 2018
By Pharmaceutical Technology 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 Pharmaceutical Technology 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 02, 2018
Pharmaceutical Technology
Quality by design highlights product and process understanding and control, integrating quality risk management, and is also considered a quality system for managing a product’s lifecycle.
Jun 02, 2018
Pharmaceutical Technology
Dissolution testing remains one of the pharmaceutical industry’s most straightforward, least expensive QC tools. Research is focusing on ways to extend its reach, improve in-vitro and in-vivo correlation, and make real-time release testing a reality.
Jun 02, 2018
Pharmaceutical Technology
By minding knowledge gaps, bio/pharma companies can avoid development pitfalls.
Jun 02, 2018
Pharmaceutical Technology
This paper analyzes the effectiveness of histogram binning for representing particle-sizing measurements with accuracy and precision.
Jun 02, 2018
Pharmaceutical Technology
FDA and Congress seek to limit the production and distribution of pain medicines.
native1_300x100
lorem ipsum