The QMN Weekly Bulletin

European Union (EU) restrictions on the use of certain hazardous substances in electronic and electrical equipment could put European devicemakers at a competitive disadvantage in non-EU markets by forcing them to use more costly and unproven alternative materials, several industry trade groups told the European Commission (EC) in comments.

The International Conference on Harmonisation’s (ICH) new Q10 guidance emphasizes management’s responsibilities for a firm’s pharmaceutical quality system, including oversight and review of outsourced activities.

As the FDA has moved to a systems-based approach for inspections, pharmaceutical manufacturers should ensure that their GMP training programs are effective, Kristina Spitler, a training manager with clinical trial materials packager and distributor Almac Clinical Services, said.

At least two New Jersey hospitals indicated they had stopped using Shelhigh Medical Devices immediately after reports of the product seizures surfaced: Robert Wood Johnson University Hospital in New Brunswick, NJ, and Hackensack University Medical Centre.

Akorn today announced the signing of an exclusive drug development and supply agreement with Cipla, a leading Indian pharmaceutical company located in Mumbai, India, for an injectable ANDA drug product for the prevention of organ transplant rejection.

King Pharmaceuticals and JHP Pharmaceuticals announced today the signing of an asset purchase agreement, pursuant to which JHP will acquire King's Rochester, Michigan sterile manufacturing facility, some of King's legacy products that are manufactured there, and the related contract manufacturing business.

The FDA’s defeat in U.S. v. Utah Medical Products will not likely alter the agency’s thinking on how it handles enforcement of the quality system regulations, according to Denise Dion, former FDA employee and senior consultant with regulatory/auditing consulting firm EduQest.

Ben Venue Laboratories just keeps getting bigger.

The FDA July 16 issued a MedWatch notice announcing that Bayer Healthcare initiated a Class 1 recall of its Ascensia Contour blood glucose monitoring system.

Welcome to the Manufacturing Quality Network. The MQN Weekly Bulletin is our new, free electronic newsletter bringing you the latest from the FDA, Congress and industry experts in the world of cGMPs for pharmaceutical and medical device manufacturers. Visit our website at www.manufacturingqualitynetwork.com for more information on regulatory changes affecting your operations and to read the latest blog entries from thought leaders in the industry.