Quality

Our management system takes into account all the demands on and expectations faced by providers to the global pharmaceuticals and medical devices industries:

            We are certified to the ISO 9001, ISO 13485 and ISO 14001 standards.
            We have CE mark certification under the Medical Device Directive (93/42/EEC).
            We are authorized to manufacture medicinal products under Eudralex (Directive 2003/94/EC).
            We are an FDA-registered contract manufacturer.
            We comply with FDA Part 820 (QSR).
            We comply with the Global Harmonization Task Force Process Validation Guidance SG3/N99-10.
            We have MSA accreditation.
            We build and maintain our cleanroom environments in accordance with ISO 14644/ISO 14698.




	Measuring Capacity We work actively with statistical process control (SPC) as the basis for approval in our process validation and in our day-to-day production. We employ engineers who define and verify our process control measuring methods. These methods are defined and approved on the basis of measurement systems analysis (MSA), a statistically based method. We offer verification of geometric product specifications in our laboratory, which is equipped with a full range of machines, including DeMeet measuring machines. This also enables us to design and verify measuring fixtures for our processes, which gives us a high degree of flexibility.