The QMN Weekly Bulletin

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

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.

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.

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.

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.

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.

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

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

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