Quality

May 12, 2015
By Pharmaceutical Technology Editors
The new Kaye Validator AVS combines accurate sensor measurements with all GMP requirements for calibration and traceability.
May 11, 2015
The basic principle behind QbD is that quality should be built into a product with an understanding of the product and process by which it is developed and manufactured along with a knowledge of the risks involved in manufacturing the product and how best to mitigate those risks.
May 02, 2015
Pharmaceutical Technology
Silver’s antimicrobial effects have been recognized since ancient times. The author reports results of evaluations and concludes that a disinfectant composed of a low-concentration suspension of silver ions is completely sporicidal with only a one-minute contact time.
May 02, 2015
Pharmaceutical Technology
The European Pharmacopoeia defines the format and content of monographs for biologicals to keep pace with recent approaches and meet the needs of its users.
May 02, 2015
Pharmaceutical Technology
Siegfried Schmitt, principal consultant, PAREXEL, discusses how to keep up with changing regulations.
Apr 24, 2015
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The company voluntarily recalls Preservative-Free Bupivacaine HCl Injection, USP due to potential iron oxide particulates.
Apr 16, 2015
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The Ph. Eur. contemplates adding specifications for sub-visible particles in eye drops and eye lotions to its monograph.
Apr 14, 2015
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The European Medicines Agency releases guidelines for addressing and reporting risks associated with medication errors.
Apr 13, 2015
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Agency teams work together to encourage manufacturers to seek approval for previously unapproved drugs.
Apr 10, 2015
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Baxter voluntarily recalls select lots of IV solutions due to possible particulate matter.