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 June 2008 Volume 42, Number 6 

The fall of Leiner Health Products

...is the cautionary tale of how an FDA inspection uncovered widespread data manipulation at a major OTC generic drug maker, leading in less than 18 months to bankruptcy in a case reminiscent of the Able Labs collapse two years ago. Along the way, investigators learned why Leiner’s internal investigation had been turned over to HR, and why Pfizer terminated its contract with Leiner. A massive house-cleaning that started with ethics training came too late to save the company.

Testing and data integrity issues gained prominence in last year’s warning letters, Atlanta District official says. Meanwhile, FDA inspections begin focusing more overseas.

Last year’s 19 drug GMP warning letters are listed, along with problem areas cited.

FDA investigators will be on the lookout for endotoxins.

Aseptic processing risks should be formally managed, FDA officials say.

Update on EU GMPs: risk management now required; annexes being updated.


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 May 2008 Volume 42, Number 5 
SUPPLY AND DISTRIBUTION VULNERABILITIES
... were highlighted in last year’s recalls. Nearly half stemmed from a flummoxed repacker and a truck chilled by a Valentine’s Day Blizzard. Class I recall numbers were swollen by erectile dysfunction APIs in dietary supplements. Class II recalls featured a close brush with DEG. Data integrity concerns lurked behind a variety of recalls. OTC drugs accounted for a greater share of recalls in 2007, and included a nearly 10-million-bottle recall of a potentially germ-spreading mouthwash. Meanwhile, cold chain concerns led to several vaccine recalls. Cap crimping provision draws fire as U.S. drug makers worry that EU Annex 1 revision could force expensive cleanroom modifications, even as they join EU manufacturers in applauding the revision’s relaxation of requirements for particulate control during the manufacture of sterile drug products. Even API from complex plant and animal sources must have impurity specifications under the ICH Q7A guidance, FDA tells Changzhou SPL in warning letter. The firm, which supplied Baxter with contaminated heparin API linked to numerous adverse reactions and deaths, should have done a better job testing the heparin and evaluating suppliers, FDA said.
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 April 2008 Volume 42, Number 4 
Restoring trust
...Now that suspect ingredients from China have infiltrated legitimate supply chains for glycerin, pet food and heparin, drug makers are asking what more they must do to remain confident in the integrity of their own supply chains. FDA urges them to audit more suppliers more thoroughly, while APIC’s Oldenhof calls for testing and auditing API makers to build ‘justified trust’ and gives some tips on what to look for. Some technology approaches draw favor, such as fingerprinting facilities by examining their products. Third-party solutions to auditing excipient and API makers are promoted, though uptake has been slow. Time to add suppliers in China? Despite all the bad news, Pfizer is looking to do just that, confident in the protections afforded by its global supply chain quality assurance. FDA goes global with plans to place a foreign service cadre in China, India, elsewhere. Regulators are collaborating to address challenges of globalization, EMEA official says. As ‘cold chain’ requirements proliferate temperature control heats up for drug makers, USP.
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 March 2008 Volume 42, Number 3 
WHO’S NEXT?
... Baxter’s heparin woes, related to a supply chain that stretches all the way to pig farms in China, raise questions about the ability of drug manufacturers to ensure the quality of drugs produced by globally sprawling enterprises. While the search for a root cause continues, some lessons already are clear: you can’t always count on FDA or host nation regulators to police suppliers; you can’t always be sure of your own ability to routinely detect deadly contaminants; and if something goes wrong, it could be front page news everywhere. Rogues, counterfeiters threaten Europe: Compliant API makers seen as losing market-share battle against rogue API firms and a complex network of traders and brokers. EU ponders moves on counterfeits after consultant says not to worry. EU regulators face new challenges monitoring increasingly complex, distributed enterprises. In other news: FDA’s first GMP rule in over a decade slowed by adverse comments. FDA fears microbial organisms might lurk in drugs that pass USP microbial limits tests. Merits of granular Quality Overall Summaries debated in DIA session on eCTDs. New FDA advisory committee recommends standard template for recall notices. Sterility controls cited in recall of prefilled heparin syringes.
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