Successful FDA Inspection at Gerresheimer Medical Plastic Systems Dongguan in China
Wackersdorf, September 12, 2012 - Gerresheimer Medical Plastic Systems Dongguan Co. is an FDA-inspected medical device manufacturer for the production of a new inhaler. As part of the product’s drug approval on the American market, the entire value creation chain was carefully examined in accordance with the strictest standards.
The inspection’s success has shown that the Chinese facility of Gerresheimer MPS can pass the inspection of all quality inspections. Bernd Stenzel (Director Quality Management, Gerresheimer Regensburg GmbH, Wackersdorf) is proud of the result: “The inspection shows that our efforts over the past few years to develop a robust management system have been successful and that we can demonstrate compliance with all applicable rules and standards.”
The inspection of the Food and Drug Administration (FDA) took place from August 14 - 17. The reason for this inspection was the new drug application (NDA) from a customer, which is preparing the market approval for a new inhaler plus drug at the American Food and Drug Agency. As part of the pre-approval inspection (PAI) of the Gerresheimer facility in Dongguan, the management system and the entire product production was inspected from incoming to outgoing goods. This includes the purchasing of rubber and metal parts, the injection molding process, the assembly and testing, the laser printing and the tamper-resistant sealing processes. The injection molding, assembly, inspection, and tamper-resistant sealing processes take place in a clean room of the ISO class 8.
Gerresheimer is a globally leading manufacturer of high-quality special products made from glass and plastic for the international pharmaceutical and healthcare industry. Our wide product portfolio extends from medicine bottles to complex drug delivery systems such as injection systems, insulin pens, and inhalers for the safe dosaging and application of medications. Together with our partners, we develop solutions that set the bar and serve as an example for the entire industry.
Our group of companies generates sales of approximately one billion Euros in its 47 locations in Europe, North and South America, as well as Asia, and employs approximately 11,000 people. The group systematically improves its market position through first-rate technologies, convincing innovations, and targeted investments.
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