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Theqmnweeklybulletin

Dec. 16, 2011

Vol. 3 No. 50

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Revised ICH Guidance on QbD Answers Design Space Questions

The FDA is addressing drug industry confusion over design space requirements for its quality-by-design (QbD) program in an updated harmonized guidance. Read More

Sterility 483, Warning Letter Show Failures at Biolab

Knowledge of sterilization failures and failure to remedy them were among violations at Bayamon, Puerto Rico-based Biolab, an FDA Form 483 and subsequent warning letter state. Read More

FDA Warning Asks Novartis for Global Manufacturing Assessment

The FDA is asking Novartis for a comprehensive, global manufacturing assessment after it sharply scored the company for multiple repeated quality failures at plants operated by its Sandoz subsidiary. Read More

Neptune Announces Production Facility Expansion

Neptune Technologies and Bioressources, a manufacturer of phospholipid products for the pharmaceutical industry, has announced the commencement of its Phase I plant expansion at Sherbrooke, Québec. Read More

AstraZeneca Acquires Chinese Generics Maker, Guangdong BeiKang Pharma

AstraZeneca announced it has entered into an agreement to acquire Guangdong BeiKang Pharmaceutical, a privately-owned generics manufacturing company, based in Conghua City, Guangdong province, China. Read More

N.C. Novartis Site Is First Cell-Based Flu Vaccine Facility in the Country

If a flu pandemic strikes the United States, a Novartis plant in North Carolina now stands ready to respond with vaccine techniques that offer speed and scalability advantages over traditional vaccine-making methods. Read More

LDR Expands in North Austin Space

LDR Holding, a medical device company, has moved into a larger office in North Austin to accommodate its growth. Read More

Bedford: Drug-Making Plant Suspends Operations

A drug manufacturing plant which employs 1,400 people has temporarily suspended all operations. Read More

Biogen Deal Generates Jobs at Newburyport Chemical Company

PCI Synthesis, a provider of specialty chemical products to pharmaceutical and biotechnology companies, has completed an expansion at its chemical facility in Devens, Mass. Read More