Merck KGaA manufacturing under scrutiny by FDA
pharmafile | March 27, 2012 | News story | Manufacturing and Production | FDA, Merck KGaA, Rebif, Violations, manufacturing
The US Food and Drug Administration has asked Merck KGaA to undertake a ‘comprehensive and global assessment’ of its manufacturing network after inspections uncovered quality issues at three of its European plants.
A warning letter sent to the firm in December and published on the FDA’s website recently, cites various Good Manufacturing Practice (GMP) violations at the facilities in Corsier-sur-Vevey and Aubonne in Switzerland and Tiburtina in Italy, including issues that affected all three sites.
Corsier-sur-Vevey makes active pharmaceutical ingredients (APIs), while Aubonne produced finished dosage forms and Tiburtina serves as a testing facility for products, including those destined for the US market, according to the letter.
Among the violations uncovered during site inspections last summer included changes to equipment, production and quality control processes and other factors that were not reported to the FDA, which was observed at all three sites.
At Aubonne, Merck failed to establish written procedures to prevent microbial contamination of supposedly sterile drug products as well as for handling customer complaints, including one example where an injectable product was reportedly supplied with bent needles.
The company also had not established “scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, in-process materials, and drug products conform to appropriate standards of identity, strength, quality, and purity,” according to the FDA.
The Tiburtina facility was found wanting for not investigating API batch failures properly, and not setting clear timeframes for carrying out such investigations.
“We note that some of the CGMP violations listed in this letter impacted all three Merck KGaA facilities,” says the letter.
Prompt action needs be to taken “to ensure global, adequate, and timely resolution of the issues, including making needed improvements to your quality system,” according to the FDA, which notes that failure to do so could lead to a block on importing materials made at the three sites.
Aubonne is involved in the manufacture of a number of recombinant products sold by the company’s Merck Serono unit, including Rebif (interferon beta-1a) for multiple sclerosis and fertility drug Gonal-f (follitropin alfa). Vevey’s main activity is in producing the API for Rebif.
Phil Taylor
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