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July 20, 2007

Vol. 1 No. 4

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Hazardous Substance Restrictions Affecting European Device Industry

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. Read More

ICH Q10 Emphasizes Management Responsibility for Quality Systems

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. Read More

Expert: Firms Should Ensure Adequacy of Training Programs

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. Read More

Shelhigh Medical Devices Agrees to FDA Terms – Part Two

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. Read More

Akorn and Cipla Announce the Signing of an Exclusive Drug Development and Supply Agreement for an Injectable ANDA Drug Product for the Prevention of Organ Transplant Rejection

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. Read More

King Pharmaceuticals to Sell Rochester, Michigan Manufacturing Facility to JHP Pharmaceuticals

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. Read More

Company’s Legal Victory Against FDA Doesn’t Change Policy

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. Read More

Ben Venue Laboratories to Add Drug Manufacturing Plant in Bedford

Ben Venue Laboratories just keeps getting bigger. Read More

FDA Announces Bayer Recall of Blood Glucose Monitoring System

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. Read More

Editor's Note

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 for more information on regulatory changes affecting your operations and to read the latest blog entries from thought leaders in the industry. Read More