Drug GMP Report

Amid continuing concern that breaks in the global supply chain will beget another heparin crisis, FDA inspectors are upping scrutiny of drug and device manufacturers’ supplier controls to ensure they are sufficiently robust and clearly articulated in scientific terms, agency officials say.

The FDA is addressing drug industry confusion over design space requirements for its quality-by-design (QbD) program in an updated harmonized guidance.

The drug industry is seeing a spike in pharmaceutical recalls as the agency ramps up inspections and warning letters, a new report states.

Recent positive regulatory inspections of Genzyme’s new Framingham, Mass., facility are lifting hopes that the agency will approve the plant in the first quarter of 2012, and in the meantime allow for additional sales of the company’s Fabry disease drug Fabrazyme, the drugmaker says.

An FDA final guidance gives deliberately vague advice on whether drugmakers should disclose physical-chemical identifiers (PCIDs) in drug labeling, despite sponsors’ requests for additional clarification.

Sarati International, a Los Fresnos, Texas-based contract manufacturer, has not established a quality control training program or trained quality personnel, according to an FDA Form 483.

Axara Pharmaceuticals has released multiple batches of finished OTC drug products that did not undergo adequate strength and purity testing, according to an FDA Form 483.

Contract manufacturer Neos Therapeutics did not fully establish the reliability of raw materials from suppliers that it used in finished drugs, according to an FDA Form 483.

The FDA has warned International Isotopes for six GMP violations at its Idaho Falls, Idaho, plant, including identity test failures.

The FDA has warned Mylan’s Caguas, Puerto Rico, facility for cGMP violations, including a lack of specification testing, for finished drug products.

Despite increasing costs and a shaky quality record, India and China will continue for now to supply active pharmaceutical ingredients (API) at a steady clip, outpacing other foreign suppliers, industry analysts predict.

The FDA has warned Jenahexal, a Jena, Germany-based subsidiary of Sandoz, for marketing four unapproved homeopathic injectable drugs and for cGMP violations, including inadequate aseptic procedures.

Teva Pharmaceutical’s Irvine, Calif., plant is on pace to resume full manufacturing by next spring, the company says.

The FDA has warned Dental Technologies for cGMP violations and for manufacturing unapproved prescription drugs, including a fluoride foam and an oral solution.

The FDA is considering requiring electronic recall information for vaccines, allergenics and other biologic drug products.

The European Medicines Agency (EMA) is recommending a recall of three cancer drugs made by Boehringer Ingelheim’s Ben Venue Laboratories after a joint regulatory inspection found sterilization problems and other manufacturing shortcomings.

Stepped-up FDA enforcement against corporate officials is having a counterproductive “paralyzing effect” on drugmakers’ good-faith efforts on GMPs and other compliance programs, pharma defense lawyers say.