WE ARE COMMITTED TO QUALITY
Accredited according to:
- GMP certified by Swissmedic
- FDA established (Establishment Identifier 3008262422)
- ISO/IEC 17025 accredited (STS 0023) by Swiss Accreditation Service
GMP certified by Swissmedic
Suisse TP has been duly authorized by Swissmedic, the Swiss Agency for Therapeutic Products, to manufacture medicinal products. This authorization allows Suisse TP to perform pharmaceutical analyses and to manufacture active pharmaceutical ingredients (API) for use in clinical trials within the standard of Good Manufacturing Practice (GMP). The certificate is based on inspections performed in accordance with the requirements of good practice in manufacturing and quality control of the Pharmaceutical Inspection Convention/Cooperation Scheme (PIC/S) and the Directives of the European Commission.
The US Food and Drug Administration (FDA) successfully inspected Suisse Technology Partners AG. Accordingly, Suisse Technology Partners AG has been accepted and registered with the FDA as a test facility for analyzing pharmaceutical products. The registration number for the Suisse Technology Partners AG is FEI 300 826 2422.
In addition, the initial self-identification of the Suisse Technology Partners AG, as required by the Generic Drug User Fee Amendments (GDUFA), has successfully passed validation and has been accepted by the FDA. Suisse Technology Partners AG is fully committed to maintain this status and to annually reconfirm the required identification information to FDA.
ISO/IEC 17025 accredited (STS 0023) by Swiss Accreditation Service
The Swiss Accreditation Service SAS examines and accredits the conformity assessment bodies (CABs) on the basis of the relevant international standards. Based on the Accreditation and Designation Ordinance dated 17 June 1996 and on the
advice of the Federal Accreditation Commission, the Swiss Accreditation Service (SAS) grants to Suisse Technology Partners AG the accreditation as Testing laboratory for chemical, physical and mechanical tests of metallic material, environmental samples and elements in organic materials and salts.
Handling controlled substances - SwissMedic
Suisse Technology Partners has the federal authorization to handle controlled substances according to Art. 2 Bst. h BetmKV.
This ordinance regulates the authorization and control of narcotics, psychotropic substances, precursors and auxiliary chemicals under Article 2 BetmG and of raw materials and products with narcotic-like effects under Article 7 BetmG.
CENTRALIZED MANAGEMENT – EFFICIENCY AND EFFECTIVENESS
Our certified, customer and process oriented Integrated Management System (IMS) combines relevant management areas like quality management, risk management, data protection management, knowledge and ideas management, EHS (Environment, Health, Safety) management in one consistent management concept.
INTERNAL AND EXTERNAL MONITORING
Strictly implemented internal and external audit processes are a must. Internal audits are examining and eliminating issues related to our practices and processes.
In addition to help ensure organizational compliance with applicable laws, regulations, and standards, our external auditing provides independent reviews and analysis of our internal controls.
Suisse TP has been successfully inspected and qualified by many customers.