Mastered the king's class of quality inspections

Mastered the king's class of quality inspections

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 process in the American market, the entire value chain was scrutinized under the strictest standards.

With the successful inspection, the Chinese site of Gerresheimer MPS has mastered the top tier of quality inspections. Bernd Stenzel (Director of Quality Management, Gerresheimer Regensburg GmbH, Wackersdorf) is proud of the result: "The inspection shows that our efforts over the past years in building a robust management system have been successful and that we can demonstrate compliance with current regulations."

The inspection by the Food and Drug Administration (FDA) took place from August 14 to 17. The occasion was the New Drug Application (NDA) of a customer, which prepares the market approval of a new inhaler including medication with the US Food and Drug Administration. During the Pre-Approval Inspection (PAI) of the Gerresheimer site in Dongguan, the management system and the entire product manufacturing process, from incoming raw materials to outgoing finished products, were thoroughly examined. This includes the procurement of rubber and metal parts, injection molding, assembly and testing, laser printing, and the original authenticity sealing. Injection molding, assembly, testing, and authenticity sealing take place in the ISO Class 8 cleanroom.