Quality assurance

EMCM is an ISO 9001:2000/EN ISO 13485:2003/CAN/CSA ISO 13485:2003 certified company with a pharmaceutical license to manufacture medicines, and is subject to national, European and US (FDA) inspections to be able to manufacture products for global markets.

An effective Quality Management System is operating to control and to assure that only high quality and safe products will enter the market and that compliance with the applicable regulations is maintained.

Training programs are established and maintained on all levels of the organization and include basic GMP, pharmaceutical workmanship, pharmaceutical techniques and various function specific training depending on activities and position within the organization.

According to standard procedures, EMCM performs validation and/or verification of processes, qualification of equipment, utilities and analytical methods. All critical processes for manufacturing medical devices and pharmaceuticals are validated. A Master Validation Plan describes the requirements and structure, including responsibilities for the execution of validation and qualification. Equipment qualification follows the IQ/OQ/PQ qualifications, according to planning. Routine maintenance and calibration are structurally planned and executed.