Quality Control

Because of a "suspected quality defect," some European Union (EU) Member States have stopped the use of some anti-influenza vaccines manufactured by Novartis Vaccines, the European Medicines Agency (EMA) reports in a press release. "The suspected defect involves the aggregation of proteins that are a normal part of the vaccines," the EMA states. It adds that halting use is a precautionary action because to date there are no reports that the suspected defect affects vaccine safety or efficacy.

Packagers can step up quality and address inevitable variations through a better-informed product development process.

Product quality has been suffering as of late, with recalls of FDA-regulated products skyrocketing. Recalls for products overseen by all FDA centers totaled 9288 in 2011, compared with 4266 in 2006.

Speakers at the Pharmapack North America conference in May argued that product quality could be better ensured through better product and process understanding and better risk management.

This week Endo Pharmaceuticals reported that several of its products may experience a "constraint" or "disruption" in supply following the temporary shutdown of Novartis Consumer Health Inc.'s Lincoln, NE, manufacturing facility, where these Endo drugs have been manufactured.

Packaging inconsistencies as well as broken or chipped tablets have prompted Novartis Consumer Health Inc. (NCH) to conduct a sweeping recall.

To address what is becoming a "significant public health problem," FDA this week released the report, "A Review of FDA's Approach to Medical Product Shortages." In particular, it details several agency concerns about sterile injectables, which have accounted for the majority of drugs in short supply. FDA's findings bring to mind the number of drug recalls the industry has seen over the last couple years because of quality concerns.