Drug GMP Report

Two closely watched Senate bills cleared the Senate Committee on Health, Education, Labor and Pensions last month.

After settling a long-running compliance case with the Justice Department, Indian drugmaker Ranbaxy trumpeted a list of quality “enhancements” it is making that closely track manufacturing recommendations FDA officials persistently promote to prevent problems.

Google searches, detailed contracts and audits-a-plenty: This is the recipe that one expert industry working group asks drugmakers to follow to guard against illegal drug diversion.

The same GMPs that finished-dose pharmaceutical companies in Canada are required to follow will soon apply to all active pharmaceutical ingredients (API) used in the country.

The FDA issued two enforcement alerts last month, highlighting an ever-present quality hurdle for drugmakers: keeping particulates out of their products.

Ames Goldsmith is speculating whether to remain an active pharmaceutical ingredient (API) manufacturer after the company received a Form 483 for documentation issues, some of which were repeats.

Cardinal Health, which manufactures positron emission topography (PET) drugs at a Tampa, Fla. plant, received a Form 483 for thin investigations into batch failures.

Oxygen Development received a Form 483 for not performing certain key quality control procedures.

A fresh Form 483 handed to Novartis Consumer Health’s troubled Lincoln, Neb., plant reveals efforts taken by the OTC drugmaker to get back on track have not always worked.

Alexion is reviewing its analytical methodologies and procedures to ensure its risk assessments meet the FDA’s expectations, the drugmaker said.

Australia’s Therapeutic Goods Administration (TGA) has released revisions to 2,000 GMP codes that apply to biologic drugs, blood and tissue components and cellular therapy products.

FDA and U.S. Pharmacopeial Convention (USP) officials say proactive industry participation — mainly by offering up drug samples and technical information — is vital to improving the quality of OTC finished drugs, the subject of recent high-profile recalls.

An article in the May issue of Drug GMP Report, “Biotest Recalls Biologic Drug Due to Particles,” incorrectly stated that the drugmaker noted that particulates in the drug Bivigam appeared in the solution upon agitation. In fact, the drugmaker stated that it found that the particulates dissolved back into the solution upon agitation.