The QMN Weekly Bulletin

Device manufacturers should know and understand the agency investigators auditing their facilities, John Sawyer, vice president of quality assurance and regulatory affairs for Welch Allyn, said.

The European Medicines Agency (EMEA) plans to update Chapter 5 of its GMP Guide to reflect the agency’s requirements that active substances and certain excipients, also known as “starting materials” used as components for pharmaceutical products, be manufactured according to good manufacturing practices (GMPs).

If antimicrobials are added to personal protective equipment (PPE), it is important to choose the antimicrobials wisely to avoid contributing to the “already serious problem of resistant microbes,” Tom Page, director of Environmental and Regulatory Affairs for Cupron, said.

Medical device maker Respironics said it will build a $32 million manufacturing plant for sleep therapy devices.

Schering-Plough announced the dissolution of the Consent Decree of Permanent Injunction by the U.S. District Court for the District of New Jersey.

The Twin Cities operation of Boston Scientific, with nearly 6,500 employees, apparently is part of a companywide review of where and how to reduce expenses and head count in order to shore up its balance sheet.

British pharmaceutical company Shire has missed a self-imposed July deadline to finalize plans for a new manufacturing facility in Lexington and has placed the blame for the delay on the slow pace of negotiations for city and state tax incentives.

Hungarian pharma producer Egis believes that a newly inaugurated pharmaceutical packaging factory near Russia’s capital, Moscow, built by Egis and its French parent company Servier, will recover the $49 million investment within six or seven years, Egis CFO Laszlo Marosffy told reporters on Thursday.

The FDA warned implant maker MetaSurg for its complaint-handling procedures, but the company says a customer complaint cited in the letter was actually a suggestion solicited by MetaSurg.