By Milton Boyer, President, OSO Biopharmaceutical Manufacturing
The changing regulatory environment is shaping a new paradigm between drug sponsors and contract manufacturing organizations (CMOs). One key aspect is demonstrated quite nicely in a case study from February 2012 (read it here), when the FDA issued a warning letter to a contract manufacturing organization.
By Jane Metcalfe, BSc (Hons), MSc, Field Applications Specialist, Bioquell UK Ltd
This white paper focuses on the challenges facing modern oncology pharmacies concerning the aseptic preparation of cytotoxic drug compounds. It considers the current regulatory and health and safety issues faced by pharmacists and details some of the measures to tackle these problems such as the use of isolator technology and the application of good manufacturing practice and quality risk management principles.
By Paul Miller, Vice President and General Manager, Nilfisk Industrial Vacuums
An estimated 30,000 U.S. facilities are at risk for a combustible dust fire or explosion, according to the Occupational Safety and Health Administration (OSHA). Many of you are likely thinking, “Well, not my company.”
Featuring Carrie Magillivray Program VP Mobile Services, M2M and Network Infastructure
New applications for the tracking of cargo and assets that are time- and temperature-sensitive and of significant value.
By Max Blomberg, Director of Operations, Meissner Filtration Products; and Trisha Gladd, Editor, Bioresearch Online and Pharmaceutical Online
Meissner Filtration Products recently introduced two new products related to single-use systems — a next-generation, single-use mixing system and a plug-and-play filter solution.
The 4th Traceability & The Drug Quality and Security Act Summit, May 15 and 16, 2014, at the Sonesta Hotel in Philadelphia, PA, brings together a cross section of supply chain, serialization, traceability, security, and brand protection experts to discuss the impact of the DQSA, best practices to optimize and protect your supply chain and how to provide business value through serialization and pedigree beyond regulatory compliance. Register today with discount code "C452LCS".