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 August 2008 Volume 42, Number 8 

Quality by design and risk management for biotech products

...will be explored in an FDA pilot program modeled after agency’s small-molecule CMC review pilot. New program will address not just biotech NDAs and BLAs but also manufacturing supplements using new ‘expanded change protocols.’ FDA seeks diverse array of pilots, including proposals for monoclonal antibody platforms, protein therapeutics, compliance-related issues, and novel approaches to linking attributes to safety and efficacy. Acceptance criteria discussed. Limited to 15 pilots.

FDA went to court for a look at Ranbaxy’s internal audits despite its longstanding policy against routinely reviewing such documents. However, a 1996 revision made exceptions for cases like Ranbaxy’s, in which the agency is pursuing allegations of fraud.

FDA exempts Phase I drugs from GMPs after addressing concerns that quality of investigational new drugs might decline. New Phase I guidance fills gaps but uncertainties remain. GMPs still apply to phases II and III, with no relief in sight. Large manufacturers likely to continue complying with GMPs for Phase I because they use the same batches for all phases of clinical trials.

Generic drug reviews falling behind despite new question-based-review approach due to increasing workload and declining resources, including a lack of user fees. How to improve QbR and microbiology submissions and reduce first-cycle review times. How more frequently updated dissolution and inactive ingredient databases could help.

FDA should stop letting chemistry reviews delay ANDAs, says HHS OIG.


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 July 2008 Volume 42, Number 7 
As regulatory anti-counterfeiting approaches diverge
...industry seeks global harmonization. Counterfeiting grows while lack of cooperation hampers enforcement. WHO recommends measures to improve coordination. China looks to close API loophole. FDA hears from industry about pedigrees, RFID, 2D barcodes and GS1. Concerns raised about EU parallel trade. EU proposal draws industry support, though some question mandatory sealing, and questions remain about counterfeit APIs. Holograms appear to be useful tools for anti-counterfeiting in Malaysia and Nigeria. Incremental approach urged. Electronic pedigree pioneered in California, but implementation delayed. Harmonized GS1 coding pilot could enhance integrity of EU drug supply. How WHO and INTERPOLcaught anti-malarial counterfeiters. Asia eclipsing Europe as top destination for FDA investigators. Final Q10 Guideline addresses ownership changes and outsourcing.
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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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