Drug GMP Report

Drugmakers could see fewer inspections under a draft Senate bill that would jettison the 1938 FD&C Act’s requirement that domestic manufacturing facilities be inspected at least once every two years.

Proposed legislation to establish a system for tracking drugs lot by lot would not protect supply chain safety as well as a system that tracks vials, FDA officials and drugmakers say.

The FDA and its EU and Australian counterparts have developed a blueprint for operating joint GMP inspections of active pharmaceutical ingredient (API) manufacturing facilities, the Australian Therapeutic Goods Administration (TGA) says.

ATHENS, Ga. — Drug manufacturers should take steps now to ensure the quality of suppliers’ glass vials and prevent contamination as they wait for a badly needed revision to U.S. Pharmacopeia (USP) glass standards, a drugmaker says.

Less than a year after approval and before the product could really get off the ground, the FDA has issued a MedWatch notice on a recall of The Medicines Company’s anticoagulant Argatroban injection because of visible particulates.

The increased use of automated control systems for cut labeling can reduce the risk of human error during the packaging process, the FDA says in a regulatory tweak that allows drugmakers greater flexibility in meeting manufacturing requirements.

GlaxoSmithKline Consumer Healthcare has received an FDA Form 483 for not conducting internal audits at its Saint Louis, Mo., plant as often as required by company protocol.

Employees at Alkermes’ Wilmington, Ohio, facility repeatedly find metallic particles in drug product samples during testing, but remediation efforts are thwarted by inadequate plant procedures, a Form 483 handed to the global biopharmaceutical company states.

A seven-observation Form 483 handed to Hi-Tech Phamacal cites deficient dust control at the contract manufacturer’s Amityville, N.Y., facility.

ATHENS, Ga. — The FDA needs dramatic new powers from Congress, including the ability to share trade secrets and proprietary information with other regulators, to better police the drug industry’s supply chain, a top FDA official says.

Over the course of three days in March, the Senate took two actions aimed at strengthening the pharmaceutical supply chain: The Judiciary Committee approved a bill that increases penalties for stealing prescription drugs, and the full Senate passed a bill that would boost possible prison time and penalties for those convicted of manufacturing, selling or trafficking counterfeit drugs.

Drugmakers may soon be able to get critical shortage drugs to market faster with a proposed shortcut for proving manufacturing compliance that’s included in draft legislation to reauthorize the FDA’s user fee programs.

The widow of an Idaho Fabry disease patient who died during a shortage of Genzyme’s Fabrazyme is suing the drugmaker, claiming it arbitrarily rationed the drug in favor of young patients and failed to adequately warn about the dangers of taking the drug at reduced doses.

The FDA wants Warner Chilcott’s Fajardo, Puerto Rico, plant to do a retrospective review of its stability program for all approved products on concerns that some may not meet specifications throughout their shelf life, according to a recent warning letter.

An FDA plan to add 16 additional drug and food inspectors in China has gained the support of House appropriators, but one vocal Democrat is calling for less reliance on user fees if the agency would essentially subsidize foreign regulators.

China’s State Food and Drug Administration (SFDA) has launched a four-month nationwide field program aimed at routing out businesses that provide inferior and counterfeit drugs.