Drug GMP Report

A planned, first-of-its-kind, U.S. standard on supply chain risk management will include input from a handful of drugmakers to highlight the impact that compliance lapses have on supply chain security, says the chair of a newly formed industrywide panel developing the standard.

Sanofi Pasteur has suspended production at its Toronto, Canada, plant to address mold troubles that recently landed the drugmaker an FDA Form 483 and prompted global shortages of a tuberculosis (TB) vaccine and a bladder cancer treatment produced there, the company says.

Exemplar Pharmaceuticals, a contract manufacturer of nasal sprays and other aerosol-based drugs, was handed a Form 483 for process control deficiencies tied to filling foul ups.

The FDA is an important part of the solution to drug shortage crises, not a contributing factor to the issue, the agency wrote in response to a congressional report that blamed the agency’s regulatory actions for limiting the manufacturing capacity of much-needed products.

Drugmakers striving to comply with manufacturing regulations and stay on the FDA’s good side should turn their attention to preventing human error, an industry official says — and automated systems are key to solving this problem.

One of Sanofi Pasteur’s French manufacturing facilities received an FDA Form 483 for straying from agency regulations on investigating discrepancies and testing samples of supplied materials.

Tower Laboratories, a contract manufacturer of OTC drugs, has received an FDA Form 483 for failure to fully investigate potential metal contamination of raw materials and finished products.

Dialysis-drug maker Fresenius has been handed a Form 483 after an FDA inspection of its Ogden, Utah, facility raised concerns that post-sterilization visual inspections performed on solution bags may not be effective at catching leaks or contaminants.

The FDA has warned Spanish industrial giant and active pharmaceutical ingredient (API) maker Ercros S.A. for cGMP nonconformities, including various validation lapses and building disrepair that invites pests.

An international coalition of pharma supply chain stakeholders is calling on the U.S.-based accreditor of internet domain name registrars (DNRs) to do more to combat illicit online sales of prescription drugs.

Compania Internacional de Comercio (CIC), a Mexican maker of OTC topical ointments and gels, has been handed an FDA warning letter for straying from the agency’s GMP regulations, including failing to document analytical tests and GMP procedures.

Chinese-made drugs approved by the World Health Organization (WHO) are seven times more likely to be substandard, degraded or counterfeit than similar Indian-made drugs approved by the WHO, according to a new study.

The international Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the European Medicines Agency (EMA) are harmonizing their GMP guides for drugs to ease the flow of shared inspection data.

Dr. Reddy’s can once again export products from its Morelos, Mexico, manufacturing facility to the U.S. thanks to an FDA closeout letter and the removal of an import alert that stemmed from an unfavorable agency inspection more than a year ago.

PHILADELPHIA — International cooperation between regulators is “taking off” — a trend that could limit the amount of duplicate inspections drugmakers face, a top CDER official says.

The FDA has handed Luitpold Pharmaceuticals a Complete Response Letter (CRL) on its NDA for Injectafer after a recent inspection raised concerns about the drugmaker’s Shirley, N.Y., manufacturing facility.

Succinct, simply worded standard operating procedures (SOPs) that can be expressed in cartoon or flowchart format lead to higher rates of compliance, pharma experts say.