Drug GMP Report

The FDA’s quality by design (QbD) program is an “evolving process,” with the agency’s regulatory flexibility for QbD applications unresolved, FDA officials say.

Drugmakers need to prioritize data integrity risks during manufacturing, and should validate and monitor computerized systems to ensure they are performing as intended, a quality management expert says.

The FDA warned SmithKline Beecham, a UK subsidiary of GlaxoSmithKline (GSK), for inadequate aseptic procedures and other cGMP violations.

The FDA is eyeing additional steps to ensure uniform quality of the same generic drug produced by different manufacturers, and between different lots of the same product produced by a drugmaker, Keith Webber, acting director of the Office of Generic Drugs (OGD), says.

With the FDA pushing drugmakers to put senior managers in charge of quality systems, companies’ top brass should expect to face scrutiny during inspections, agency officials say.

The FDA is still dissatisfied with Hospira’s Rocky Mount, N.C., facility following a 2010 warning letter, despite its efforts to correct FDA-cited deficiencies, the company said in a special investor’s call.

Enhanced food facility inspection authorities granted to the FDA in the Food Safety Modernization Act (FSMA) should also apply to drug facilities, agency officials say.

The FDA handed Novartis’ generics unit Sandoz a Form 483 for inadequate quality control and manufacturing validation at its Wilson, N.C., facility.

Hospira, still facing heat over persistent GMP issues at its Rocky Mount, N.C., plant, has received a Form 483 for quality control and training issues at its Austin, Texas, facility.

Teva Pharmaceuticals USA has not established control procedures to validate manufacturing processes that could affect drug product uniformity, a Form 483 states.

GMP issues at Sanofi’s Frankfurt, Germany, plant are behind a temporary shortage of diabetes drug Apidra, the company says.

The FDA will soon require generic-drug makers to submit 12 months of product stability data with ANDAs — four times as long as currently mandated — the agency has revealed.

Generic competition and ongoing enhancements to quality and manufacturing systems contributed to a slump in domestic sales and an overall earnings decline of 6 percent for Johnson & Johnson (J&J) in the third quarter, but the company’s manufacturing problems are taking a turn for the better.

To boost FDA transparency and improve the quality of enforcement data, the agency hopes to take a series of steps that include expediting data entry and inspection review and adding more context to publicly available information.

The FDA warned active pharmaceutical ingredient (API) maker Sichuan Pharmaceutical for failing to prevent cross contamination at its Pengzhou, China, plant.

The FDA aims to improve the quality and speed of inspections next year by devoting more attention to inspector training, and re-emphasizing its directive that inspectors limit their focus to two facility systems.

Media fills used to validate aseptic manufacturing procedures for positron emission tomography (PET) drugs should be conducted in production areas and employ the “broadest scope” of possible manipulations that could occur during actual production, according to an FDA draft guidance.

An international offensive against online sellers of counterfeit and illicit drugs has resulted in the seizure of some 2.5 million pills with an estimated value of $6.3 million.