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Theqmnweeklybulletin

Nov. 25, 2011

Vol. 3 No. 47

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Senior Management ‘Fair Game’ in Quality System Citations

With the FDA pushing drugmakers to put senior managers in charge of quality systems, companies’ top brass should expect to face scrutiny during inspections, agency officials say. Read More

MEAS 483 Lists CAPA, Marketing Deviations

MEAS US, a subsidiary of Measurement Specialties based in Dayton, Ohio, failed to submit a premarket notification to the FDA for three medical devices it modified, a Form 483 states. Read More

EMA Cites Need for Toxicological Guidance on Multi-Drug Facilities

The European Medicines Agency (EMA) is seeking stakeholder input on the development of toxicological guidance for use in identifying the level of risk associated with making different drug products using shared facilities. Read More

Shire Seeks U.S., EU Approval of Mass. Facility

Irish drugmaker Shire has filed an application with U.S. and European regulators to produce its Gaucher disease drug at a new manufacturing site in Massachusetts, saying the move will give it flexibility to meet global demand for treatments of rare diseases. Read More

Ferring Pharmaceuticals to Develop Major Corporate Center in Parsippany, New Jersey

Switzerland-based Ferring Pharmaceuticals today announced the purchase of a 25-acre site at 100 Interpace Parkway in Parsippany, N.J. Read More

Coldstream Laboratories Announces New VP of Manufacturing

Coldstream Laboratories, a provider of drug product research and manufacturing services, has named Dr. Vickie Hall as Vice President of Manufacturing. Read More

Sri Lanka Moving Ahead With First Pharma Zone, Project Scope Expands to Medical Equipment Manufacturing

Sri Lanka has begun preliminary work on the country’s first pharmaceutical manufacturing zone. Read More

Receiver Rejects Bids for Stirling Pharma

Efforts to sell an insolvent pharmaceutical manufacturing plant in North Sydney have gone back to the drawing board. Read More

Dr Reddy’s Seeks Denotification of Special Economic Zone at Medak

Dr Reddy’s Laboratories has requested the government denotify its Special Economic Zone (SEZ) at Medak in Andhra Pradesh, India, said a top company official. Read More