Drug GMP Report

BALTIMORE — Drug shortages, poor product quality, poor corrective actions and other “manufacturing breakdowns” have conspired to create a crisis state that demands not only strong regulatory enforcement, but also active collaboration among drugmakers to address the issue, FDA officials say.

BALTIMORE — Despite recurring pharma quality problems, drugmakers are still inclined to meet minimum manufacturing standards set by regulators, rather than make quality central to their business model.

AkzoNobel Chemicals’ Mexican manufacturing plant has received a closeout letter, resolving a 2011 warning letter for failure to investigate and prevent shipment of contaminated products.

House and Senate leaders have agreed on a final FDA user fee reauthorization package that provides the agency with most of the increased supply chain oversight powers it asked for, including new authority to stop drug imports by uncooperative foreign manufacturers and new abilities to share information with other international regulators.

Counterproductive cross-border repackaging requirements in the EU are holding back a group of drug distributors from approving a drugmaker-backed supply chain security plan to scan all treatments at the point of dispensing.

Shertech Laboratories received a Form 483 after investigators found an array of procedural lapses that ultimately led the company to halt its first try at manufacturing prescription generics.

A&Z Pharmaceutical failed to adequately investigate unexplained discrepancies in drug products tied to compression-related troubles at the company’s Deer Park, N.Y., plant, a Form 483 states.

Industrial chemical giant FMC received a Form 483 after FDA investigators found the company failed to minimize contamination risks at an alkali plant in Green River, Wyo., that makes pharmaceutical grade sodium bicarbonate and other active pharmaceutical ingredients (API).

Cephazone Pharma has received a closeout letter, resolving a 2011 warning letter that cited GMP violations and tardy responses to FDA inspection findings.

With the final FDA user fee legislation lacking language to support a national track-and-trace system for pharmaceuticals, Congress must now act fast to preempt California’s epedigree law, slated to go into effect in 2015, Sen. Michael Bennet (D-Colo.) says.

The European Medicines Agency (EMA) is stressing the need for timely, coordinated communications between EU member states when one state finds out about a drugmaker’s noncompliance with GMPs from a non-EU country’s regulators or from an international organization, such as the World Health Organization.

Congress is pointing a finger at the FDA for spurring the increase in drug shortages through stepped up enforcement actions, despite the agency’s efforts to mitigate the trend.

Clearly feeling the sting of the chromium-contaminated drug capsule scandal, China’s State Food and Drug Administration (SFDA) is proposing to draw up a “blacklist” of executives that oversee pharmaceutical companies in China found to produce substandard or counterfeit drugs.

The House has passed H.R. 4223, the SAFE Doses Act, by voice vote, taking another step toward ramped-up penalties for medical product thefts.

BALTIMORE — Proposed language redefining cGMPs included in both versions of omnibus FDA user fee legislation appears to give the agency new authority to require drugmakers to make supplier quality agreements, a compliance expert says.