The QMN Weekly Bulletin

The FDA completed its inspections of Bausch & Lomb’s Greenville, S.C., solutions manufacturing plant and distribution center and found both facilities are in acceptable compliance, the company said.

The FDA is considering how to reduce the number of 30-day manufacturing change notices that medical device companies submit to the agency, Tim Ulatowski, director of the Office of Compliance for the Center for Devices and Radiological Health (CDRH), said.

The FDA is increasingly scrutinizing manufacturers’ product complaint systems and procedures, according to David Dills, senior consultant with Parexel Consulting.

China's food and drug watchdog has revoked the production licenses of five drug manufacturers since last July.

Since the lifecycle of medical device software runs from inception to decommissioning, a lifecycle approach to the validation of production and quality-system software works best, Bob Barrett, director of systems engineering at Intertech Engineering Associates, told a seminar at the recent Medical Design & Manufacturing East Exposition and Conference.

The Middle East market for pharmaceutical manufacturing and biotechnology, already valued at over $28 billion and with annual growth in double digits, looks set for even stronger growth as some of the world’s major players eye the regional market, according to the organizers of the region’s premier industry event – Pharmaceutical Manufacturing and Biotechnology Middle East (PABME).

MetricStream, Inc., the market leader in enterprise-wide Governance, Risk, Compliance (GRC) and Quality Management solutions, today announced that Aurobindo Pharma has selected the MetricStream solution to automate its compliance processes for meeting FDA cGMP regulations.

During the first half of 2007, the FDA issued just two GMP warning letters to large pharmaceutical manufacturers, compared with five during the same period last year, agency records show.

Servier,  France's second largest pharmaceutical  company, announced it opened a drug-manufacturing plant near Moscow.