Drug GMP Report

While congressional lawmakers continue to look for a last-minute means of advancing a federal track-and-trace system for pharmaceuticals, California continues to prep its ePedigree law for implementation in 2015.

The Generic Pharmaceutical Association’s (GPhA) plan to help the FDA deal with drug shortages should launch in the coming weeks, after the FTC found it will not be anticompetitive as sensitive information will be protected.

FDA inspections of Apotheca have revealed possible metal shaving contamination and broken, leaking or damaged bottles for various drugs, resulting in a warning letter.

British drugmaker A Nelson has been cited in an FDA warning letter after an inspection found glass fragments in a batch of the company’s Clikpak drug vials.

While an impending update to the U.S. Pharmacopeia’s (USP) reference standard for heparin sodium will sharpen the drug’s monograph, there is no substitute for solid supplier quality control to prevent contaminants in heparin and other active pharmaceutical ingredients (API), FDA officials say.

Environmental monitoring programs, increasingly under scrutiny by FDA investigators, require continuous, top-level oversight and procedural accuracy to be effective, compliance experts say.

TAMPA, Fla. — An informal working group of the International Conference on Harmonisation (ICH) is looking into revising or rewriting the “dated” Q7 standard on GMPs for active pharmaceutical ingredients (API), an FDA official says.

Alliance Medical Products, a contract manufacturer of commercial and clinical drugs, failed to follow environmental monitoring plans in classified areas and storage rooms, an FDA Form 483 states.

Axara Pharmaceuticals has not justified deviations from process control procedures that resulted in drug products gone astray and equipment cleaning confusion, according to an FDA Form 483.

Sovereign Pharmaceuticals’ blend uniformity tests and batch failure investigations fall short of the company’s written procedures, an FDA Form 483 states.

TAMPA, Fla. — Now that CBER’s all-electronic Direct Recall Classification (DRC) program has been extended to non-blood products, problems with biologic drugs flagged in electronic biological product deviation reports (eBPDRs) may trigger recalls of those products under the program.

Amid lingering quality issues at a number of its manufacturing plants, Hospira reported some success in its discussions with the FDA but notes there are more trouble spots than the company previously thought.

While drugmakers should not rely on a “Plan B” for validating suppliers, there are some steps they can take if they can’t conduct sufficient quality audits — primarily beefing up incoming acceptance activities, compliance experts say.

TAMPA, Fla. — The FDA gave drugmakers some key advice for qualifying and auditing contract manufacturers: Start by requesting the same documents the agency wants to see when it begins an audit.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use has urged Pacira Pharmaceuticals’ cancer drug DepoCyte be recalled in certain EU countries, citing “manufacturing deficiencies” found at the company’s San Diego, Calif., facility.