European drug regulators report lots of plant issues in first quarter

Print 22 March 2016
Eric Sagonowsky / FiercePharmaManufacturing

Not even three months into 2016, the European Compliance Agency says that drug regulators on the continent have taken to task a dozen pharma plants around the world for substandard manufacturing practices.

The numbers draw a contrast from 2015, when, according to the EudraGMDP database, European regulators reported citations for just three pharma plants up to March 15. So far in 2016, inspectors affiliated with the European Medicines Agency have cited 5 drug plants in China, two in France, two in Spain and one each in Sweden, Romania and Poland, some of which were inspected in 2015.

The agency's report highlights a busy period for drug regulators worldwide, who have been crusading in recent months and years against poor manufacturing practices, digging up a range of issues at plants around the globe. The EMA and the United States' FDA have been highlighting recurring problems such as data manipulation and the potential for contamination, holding drugmakers' feet to the fire to bring their plants into regulation while regulatory punishments have sacked sales figures in many cases.

The ECA reports that data issues surfaced in 5 plants cited so far this year while three plants had problems with contamination potential.

In the first two months of the year, Spanish regulators cited two local drugmakers, Farma Mediterrania and Desarrollos Farmacéuticos Bajo Aragón, for Good Manufacturing Practices violations and said they planned to suspend their manufacturing operations. At Farma Mediterrania in Barcelona, inspectors said a plant lacked an effective quality-assurance system and released batches without completing manufacturing protocols, among other violations. Desarrollos Farmacéuticos Bajo Aragón, located in Alcorisa, was found to lack "a quality management system that could ensure accuracy and completeness of the critical records data."

Just days before the first Spanish regulatory notice, French officials took to task a Chinese manufacturer for 18 shortcomings including allegedly falsifying its API source and storing hoses on a dirty floor in a plant location not mentioned on the layout.

At some plants, inspectors found deficiencies numbered in the teens, while a Theravectys plant in France had 45 deficiencies. A Svenska Bioforce plant in Sweden was found to have 42 shortfalls. Notably missing from the report are plants in India, which has seen its national pharma industry hit recently from regulatory punishment.

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