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    About SAMSAM

    Quality Management System

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    Quality Management System

    Our quality management system is committed to the implementation and maintenance of a documented quality management system which is continually improved. The system is based on the requirements of the legislation, the regulatory system and ISO 9001; it also takes into account guidelines, standards and best practices from Estonian and international organizations.

    The quality system is implemented and operated by all agency`s staff. Internal audits help to provide quality assurance to management that the system is operating effectively, and contributes to the improvement of systems and processes.

    Benchmarking

    The Heads of the European Medicines Agencies have established a benchmarking exercise, the aim of which is to contribute to the development of a world-class pharmaceutical regulatory system, based on a network of agencies, operating to the best practice standards.

    The benchmarking of European Medicines Agencies (BEMA) is based on a self-assessment in four areas: organization and management; assessment of marketing authorization applications; pharmacovigilance and inspections. The internal self-assessments are then followed up by external peer-reviews. Reports from all the visited agencies are entered into a database which forms a valuable resource for best practice across the entire EU/EEA network of medicines agencies.

    OMCL

    Our laboratory is accredited according to the EVS-EN ISO/IEC 17025:2017 by the Estonian Accreditation Centre (accreditation certificate no L217.) The Scope of the accreditation is given in the annex to the accreditation certificate.