Certified quality

Our company holds a manufacturing licence pursuant to AMG § 13, has been GMP-certified according to EU directive 2001/83 and FDA-approved. GfM was recently also accredited in Japan. These distinctions serve as proof of our high level of quality assurance, which we have established over our many years of operation.

GMP (Good Manufacturing Practice) guidelines provide for quality assurance during production processes and in the production environment for pharmaceuticals, active ingredients, medical devices and environment. Quality assurance plays a central role in pharmaceutical production, as any quality deviation could have a direct effect on the health of the consumer. Our GMP-compatible quality management system – including batch release by a qualified person - is used to guarantee product quality and fulfilment of the marketing requirements of the health authorities. Our chambers, equipment, manufacturing process and our analyses are permanently subject to the standard of annex 15, EU-GMP-guideline on qualification and validation. Our proven GMP-compatible documentation system and our long standing experience in the field of manufacturing under GMP conditions have made us into an accredited partner for the refinement of your active pharmaceutical ingredients, excipients and carrier substances.

Our compliance with GMP requirements has been confirmed by numerous audits carried out by national and international customers as well as authorities. Please contact us, without obligation, should you require more information on our GMP-compatible production facilities.