Drug GMP Report

New England Compounding Center (NECC), the compounder blamed for an outbreak of fungal meningitis, violated state pharmacy law by acting as a bulk manufacturer and distributor of sterile drug products without proper registration, a preliminary investigation report states.

A new bipartisan track and trace proposal floated by House and Senate lawmakers late last month would implement a uniform national policy on drug product tracing, heading off state-by-state initiatives.

CINCINNATI — Drugmakers should keep managers out of the spotlight during internal audits so they can determine if plant operators understand compliance requirements or need additional training, industry experts say.

Slow remediation of GMP problems at Novartis’ Lincoln, Neb., OTC drug plant has dashed hopes for a pre-2013 return to production, company officials say.

CINCINNATI ­— To help the FDA meet new congressional mandates and complex globalization challenges, drugmakers need to shed their fear of reporting supply chain concerns and manufacturing flubs, agency officials say.

Lax investigations into microbial contamination of manufacturing equipment and inadequate controls to minimize such risks have landed Janssen Biotech a Form 483.

Contrary to company procedure, Jubilant Cadista’s Salisbury, Md., plant did not conduct annual GMP training for employees in 2010, a Form 483 states.

Lloyd, an animal-drug maker that recently began manufacturing drugs for human hypothyroid conditions, failed to ensure the quality of its products at its Shenandoah, Iowa, facility, according to an FDA Form 483.

Hospira is recalling one lot of lactated Ringer’s and 5 percent dextrose injection, USP, 1000 mL after receiving a report of a product unit compromised by a leaky container and a “spore-like” structured particulate.

CINCINNATI — To maintain strong sponsor-supplier relationships, quality agreements should express each side’s expectations in simple terms and avoid legal caveats, compliance experts say.

CINCINNATI ­— The FDA will issue guidance detailing what information drugmakers should share with contract manufacturing organizations (CMO) hired to work on their products, FDA officials say.

An international offensive against thousands of online peddlers of counterfeit and illicit drugs has resulted in the seizure of some 3.75 million units with an estimated value of $10.5 million.

API makers with manufacturing facilities in Canada can expect nearly $1 million dollars in initial costs and $100,000 in annual compliance and administrative costs related to proposed manufacturing regulations.

ANDAs that lack basic quality-by-design (QbD) elements will be categorized as requiring “major” amendments and more extensive FDA consideration, according to a new Manual of Policies and Procedures (MAPP) for reviewers in CDER’s Office of Generic Drugs (OGD).

The FDA is considering elevating staff that deals with drug shortages from the Office of New Drugs to the Office of the Center Director, the agency says.

Following Senate passage of the bill in September, President Barack Obama has signed the Safe Doses Act into law, increasing penalties for theft of prescription drugs and medical devices.

Ben Venue’s Bedford, Ohio plant — in the news this past year for quality problems — has restarted a handful of production lines to make some of its critical-need drugs available again.