ASM Aerosol-Service AG successfully passed the second FDA-Inspection
Möhlin, 19 October 2017 – For more than 60 years, ASM Aerosol Service AG has offered diverse services in the contract manufacturing of sophisticated products in liquid to semi-liquid form in the field of pharmaceuticals, cosmetics and technology. After 2015, ASM has now successfully passed the second FDA1)-Inspection.
The one-week inspection in September was on one hand a routine-inspection, on the other hand a Pre-Approval-Inspection for a new medicinal product, which shall enter the US market in 2018.
US-FDA inspected the entire ASM Quality Management System for cGMP2)-Compliance and for compliance with the applicable FDA regulations. The inspection included the review of production facilities, processes, quality systems and quality control. The inspection confirmed once again that all processes at ASM comply with the cGMP principles and guidelines, as well as the FDA requirements; thus ASM products may be offered and supplied for the US market.
„After an intensive week of inspection, the FDA inspection was successfully passed without issuing a Form 483. All our employees can be proud of this great achievement“, stated Peter Bernauer, CEO of ASM. „The second FDA inspection proves that ASM operates GMP production facilities with a high-performance Quality Management System. In order to achieve this, our teams broadly invest in development and continuously implement improvements in order to comply in all ASM department to the highest extent possible with the increasingly stringent regulatory standards and requirements.“
1) United States Food and Drug Administration
2) Good Manufacturing Practice: Guidelines and regulations for Quality Assurance regarding production processes and environment in manufacutring of Finished Drug Products and Drug Substances
Bettina Berger, CMO
T +41 61 855 67 80, e-mail: email@example.com