Germany’s Hameln warned by FDA over GMP failings
pharmafile | January 22, 2013 | News story | Manufacturing and Production |Â Â FDA, GMP, HamelnÂ
German contract manufacturer Hameln Pharmaceuticals was sent a warning letter by the FDA last month detailing a number of Good Manufacturing Practice (GMP) violations.
Among the criticisms in the report were that some of staff at Hameln’s Langes Feld sterile production facility were inadequately educated, trained or experienced enough to carry out their duties, giving the example of one employee who was unable to “read and accurately report microbial counts”.
There was also a lack of procedures designed to ensure that products made at the facility were in fact sterile, and a failure to operate an adequate system for monitoring environmental conditions in aseptic processing areas.
Among the violations noted by the FDA inspectors were inadequate glove change frequency, poor handling of dropped objects, and failures in personnel monitoring and sample acquisition. Hameln’s in-house sterility testing method was not equivalent to or better than USP <71>, the current gold standard.
The FDA found the violations during an inspection of the facility in June 2012, and said it sent the warning letter after responses from Hameln in July, August and September failed to remedy the situation.
The agency asked the contract manufacturer to document the specific steps it has taken to correct and prevent a recurrence of these violations, and provide supporting documentation within 15 days of receipt of the warning letter, which was dated 17 December and published on the FDA website last week.
Hameln specialises in the manufacture of sterile products used in hospitals and intensive therapy units, and won a Facility of the Year award for the Langes Feld unit in 2009 in the operational excellence category.
The company employs around 250 staff and had a turnover of €47 million in 2010, according to its latest public figures.
Phil Taylor
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