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Drugmakers and active pharmaceutical ingredient manufacturers in Europe that produce multiple products in one facility should justify exposure to contaminants and follow specific steps to clean equipment and reduce risks of cross-contamination, according to a new EU guideline. Read More
The FDA plans to more than triple its staff in China from eight direct hires to 26, advancing a key agency goal of increasing the number of inspections it conducts in the country, the sixth largest exporter of drugs and biologics to the U.S. Read More
With drugmakers facing a Jan. 1 deadline to begin complying with new product track-and-trace requirements, the FDA has announced a wide range of options that companies can choose from to satisfy the new law in a short guidance that contains no surprises for industry. Read More
Health Canada has expanded its initial import ban on Apotex’s finished product facility in Bangalore, India, to include the generics makers’ raw materials plant in the city. The agency also banned products from another India firm. Read More
The FDA warned a Georgia-based compounder and repackager for poor cleaning practices that apparently led to patients becoming infected by contaminated products. Read More
Drugmakers Sagent and Baxter Healthcare recently recalled products due to labeling mix-ups, a common quality problem that one expert says can be easily solved through an additional examination by personnel. Read More
FDA investigators are finding unprecedented data integrity problems at contract and active pharmaceutical ingredient manufacturers, even after they have been audited by the firms that hired them, an FDA official said. Read More
The FDA issued a warning letter to injectables giant Hospira after an investigation of its Victoria, Australia, plant uncovered significant GMP violations, including a failure to adequately investigate failed batches and determine levels of impurities in distributed products. Read More
The FDA slammed a Chinese active pharmaceutical ingredient (API) manufacturer for using a supplier of potentially contaminated heparin and for restricting access during an inspection. Read More
Drugmakers should upgrade their quality assurance systems to quickly identify and fix any manufacturing problems that could spiral into a shortage, according to a wide-ranging plan to address shortfalls in drug supplies. Read More
Drugmakers may soon have to report to the FDA how they decide when to launch a corrective or preventive action (CAPA) investigation, if they have a performance index for their product’s critical quality attributes and the seniority level of the employee who signs off on the annual product review. Read More