Drug GMP Report

Senate appropriators overwhelmingly approved a fiscal 2013 spending bill that provides $2.5 billion for the FDA, including $10 million to fund an expansion of the agency’s China office.

Efforts to alleviate manufacturing distress at three McNeil Consumer Healthcare plants will take longer and cost more than expected, forcing the Johnson & Johnson (J&J) subsidiary to trickle out OTC drug products through 2013 and its parent company to sweat over sales in 2012, J&J says.

Sen. Sherrod Brown (D-Ohio) had harsh criticism for FDA Commissioner Margaret Hamburg last month, questioning the agency’s lack of enforcement actions against companies’ with holes in their supply chain knowledge.

To make more than just a dent in the fight against counterfeit drugs, a global treaty is needed to galvanize the necessary resources to combat elusive criminal networks and convince skeptical stakeholders that it’s more than just a matter of Western meddling, a conservative scholar says.

The FDA is stepping up its handling of pharma and device cargo thefts, creating a cargo theft response team (CTRT) to assess companies’ action plans after a theft occurs.

A project manager at Diamond Wipes’ Chino, Calif., facility bypassed its quality control unit and allowed products deemed unfit for release to be shipped for sale anyway, a Form 483 states.

Corrective and preventive action (CAPA) procedures used to address equipment failures during batch tests at ALK-Abello’s flagship facility are inconsistently applied, an FDA Form 483 states.

CP Medical, a maker of suppository chelating products and other drugs, was handed an eight-page, 22-observation Form 483 after an inspection of its Huntington Beach, Calif., plant found inadequate validation, testing, control, reprocessing and other procedures.

The FDA’s recently deployed computer system that ranks imports according to risk was praised in a new government report, but a former agency official says it’s essentially stuck in neutral, citing the report’s chiding remarks about FDA sluggishness in integrating its legacy IT systems.

All personnel involved in aseptic manufacturing of positron emission tomography (PET) drugs should participate in at least one media fill per year, according to final FDA guidance.

GlaxoSmithKline (GSK) conducted hundreds of quality and safety audits on new and existing suppliers in 2011, uncovering scads of deviations that disqualified many potential business partners — even as GSK itself was being scolded for similar slip-ups, a company report states.

The FDA and other agencies must provide expertise, training and tools to developing nations to improve their pharma monitoring practices and prevent dangerous drugs and medical products from entering the U.S., according to a new Institute of Medicine (IOM) report.

CDER Director Janet Woodcock is urging House lawmakers to excise from their omnibus user fee draft a provision that would expedite manufacturing changes to speed shortage drugs to market, saying it’s not needed because the FDA already has the tools to make such fixes.

Contract Pharmacal has received a closeout letter, resolving a 2010 warning letter that advised it to hire a GMP consultant.

Draft International Conference on Harmonisation (ICH) guidance set for release in June will tighten regulatory controls on metal impurities in finished drug products, but drugmakers should begin analyzing planned and marketed products now, a Pfizer official urges.