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Archive for the ‘Inspection’ Category

Pfizer Explains Birth Control Pill Recall on YouTube

Wednesday, February 1st, 2012

Pfizer took to the Internet today to address its voluntary recall of approximately one million packs of birth control pills. Recalled are 28 lots of Lo/Ovral-28 (norgestrel and ethinyl estradiol) and Norgestrel and Ethinyl Estradiol Tablets (generic) birth control pills in the United States. Pfizer's Chief Medical Officer Freda Lewis-Hall explained ...

US Pharmacopeia Takes Up Supply Chain Security

Monday, December 19th, 2011

The United States Pharmacopeia is placing supply chain security at the forefront with a new general chapter on best practices for ensuring supply chain integrity and protecting consumers from poor quality and counterfeit medicines. USP General Chapter <1083>, Good Distribution Practices-Supply Chain Integrity, with the recently published USP General Chapter <1079>, ...

Solving Shortages through Serialization

Thursday, September 29th, 2011

The Institute for Safe Medication Practices (ISMP) has surveyed pharmacists and purchasing agents on drug shortages and the "gray" market again, and the bad news is that we could have just reposted our blog on last year's survey and been just as timely. Hospitals continue to struggle with drug shortages, ...

FDA: Reduce the Opportunity for Crime

Tuesday, July 12th, 2011

During a policy forum held today in Washington, DC, the Pew Health Group introduced its report, "After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs." Referring to the heparin-contamination case as a "wake-up call" to supply-chain risks, Allan Coukell, Pew's director of medical programs, said that while ...

Expert Panels To Review Glass Flaking

Friday, May 20th, 2011

The recalls of last year related to glass particulates in parenteral primary packaging has focused attention on glass delamination. As Rx-360 has reported, the phenomenon, while well described in the literature, is not well understood. In a May 5 webinar (see archives) sponsored by the American Association of Pharmaceutical Scientists--Glass ...

Will Standards and Audits Provide Enough Supply-Chain Visibility?

Tuesday, November 16th, 2010

Axendia has released the findings of its study on the global supply chain, and I wasn't at all surprised to see that what life science executives say they need is guidance from industry consortia (59%) and regulatory mandates (51%). "Our research shows that industry executives are relying less on internal ...

Healthcare Reform Could Now Depend on Voluntary Efforts toward Patient Safety

Wednesday, January 20th, 2010

After Republican Scott Brown's win in Massachusetts, political pundits are already predicting the failure of President Obama's healthcare reform efforts. But even if the bill currently tied up in Congress fails to pass, healthcare reform does not have to end. In fact, if the bill does fail, maybe healthcare reformers ...

Don’t Eliminate Redundancy!

Thursday, June 25th, 2009

FDA played enforcer today, seizing drugs made by Caraco Pharmaceutical Laboratories Ltd. While product cross contamination and inconsistent dosing were the significant issues, packaging and inspection were among the company's list of violations. According to last October's warning letter, Metformin HCI tablets were contaminated with metal, and the company explained ...