Drug GMP Report

Senators will question the FDA and drugmakers on supply chain issues this fall, allowing plenty of time to attach changes to Prescription Drug User Fee Act (PDUFA) legislation before its expected reauthorization by next summer, Sen. Tom Harkin (D-Iowa) says.

An active pharmaceutical ingredient (API) inspection pilot project involving the FDA and European Medicines Agency (EMA) is getting results and should be expanded, according to a report on the program.

The House’s proposed cuts to the FDA’s fiscal 2012 appropriations would mean about 2,000 fewer facility inspections and about 9,000 fewer import inspections as a result of staff cuts, an FDA official says.

The FDA plans to investigate the effects of continuous, rather than batch, manufacturing on product quality as one of the many goals it outlines in a crosscutting plan to advance the level of regulatory science.

A recent Dr. Reddy’s Laboratories recall of generic Zocor did not stem from shipping byproduct 2,4,6-tribromoanisole (TBA), as initially reported by the FDA, the company told DGR.

American Regent has issued a voluntary recall of its vasopressin injection because some vials may not maintain potency throughout their shelf-life, rendering the product less effective.

Pacira Pharmaceuticals received an FDA Form 483 for inadequate sterilization procedures and poor recordkeeping practices at its San Diego manufacturing plant.

A Cardinal Health 414 facility in Van Nuys, Calif., received an FDA Form 483 with three observations related to positron emission tomography (PET) drug manufacturing.

Ben Venue Laboratories’ Bedford, Ohio, facility lacks adequate oversight by the quality unit to approve or reject products, or to approve or reject established procedures or specifications affecting quality, according to an FDA Form 483.

An FDA advisory committee is recommending the agency ramp up its outreach to the pharmaceutical industry on quality by design (QbD) and create a resource center to spur more widespread adoption of the initiative.

Genzyme has hit another manufacturing obstacle as a delay in the release of Fabrazyme, the company’s Fabry disease drug, is causing late shipments.

Stronger Google barriers against online pharmacy ads — part of a settlement with the Department of Justice (DoJ) — may strengthen the legal pharmaceutical supply chain and thwart counterfeiters.

The FDA is considering requiring quality agreements between drugmakers and their suppliers as part of its push for tighter control of the pharmaceutical supply chain, an FDA consumer safety officer says.

Ben Venue Laboratories, a Boehringer Ingelheim (BI) subsidiary, is transitioning away from contract manufacturing after repeated GMP violations that led to a Health Canada import alert. 

Small companies that need to comply with cGMPs for positron emission tomography (PET) drugs may use fewer employees or rooms for multiple functions, a final guidance states.

Johnson & Johnson (J&J) subsidiary McNeil Consumer Healthcare is again recalling Tylenol products, this time for higher-than-expected levels of a compound.

The FDA is easing back from its push of quality by design (QbD) as the sole way to minimize residual drug left in transdermal patches after their prescribed use.

Sponsors of tablets with a “score” to facilitate tablet splitting should ensure the split tablet portions can meet the same finished-product testing requirements as a whole tablet of equivalent strength, an FDA draft guidance states.

Gilead Sciences received double good news from the FDA, as the agency said the manufacturing problems at its San Dimas, Calif., plant are resolved and it approved Gilead’s three-drug fixed-dose combination HIV treatment Complera.

Novartis is working with the FDA to recover products, including Excedrin caplets and eye solutions, stolen during a cargo theft.

Two Chinese companies — a biologics developer and an animal byproduct-based drugmaker — have been warned over their quality control systems and the possibility that impurities or contaminants might enter their supply chains.