Pharmaceuticals GMP ACTIVE SUBSTANCE TESTS TESTING OF Pharmaceuticals IN ACCORDANCE WITH GMP We offer active-pharmaceutical ingredient testing and stability testing for pharmaceuticals in accordance with GMP guidelines. The associated analysis is carried out using the most modern equipment, by staff with many years of experience and a high level of expertise. Our in-house radiopharmaceutical manufacturing means we have extensive experience with the special requirements of the production of pharmaceuticals. INTERDISCIPLINARY EXPERTISE Within the business unit Pharmaceuticals, we have many years of experience in the field of pharmaceutical production and quality control in accordance with GMP guidelines. Our interdisciplinary interaction with the business unit Chemical Analytics means we are able to offer further extensive investigations all under one roof. Our references include global pharmaceutical companies and medium sized Austrian pharmaceutical companies who rely on our skills, quality and customer focus. STABILITY STORAGE IN ACCORDANCE WITH ICH GUIDELINES Pharmaceuticals are tested for their active pharmaceuticals ingredient content and their stability over defined periods of time. Using validated methods, stability testing samples are examined along the desired parameters with the highest possible level of precision in a reproducible, comparable way, and its shelf life is tested. Storage in accordance with ICH storage conditions is possible. HIGH FLEXIBILITY We offer high flexibility for product-specific and customer-specific test methods. We have the technical abilities and the necessary experience to establish new test methods and customer-specific resolutions. OUR SERVICES • Active pharmaceutical ingredient and stability testing in accordance with GMP guidelines • Stability storage in accordance with ICH guidelines • Controlled laboratory for critical cytostatic testing • High flexibility in product-specific and customer-specific test methods ADVANTAGES FOR YOU • Customer-focused solutions • Short reaction times • Many years of experience in the production of pharmaceuticals and in quality control Pharmaceuticals GMP ACTIVE SUBSTANCE TESTS TECHNICAL EQUIPMENT In all areas of activity, a large number of state-of-the-art devices are available for the analysis of organic and inorganic substances. In the business unit Chemical Analytics, the following devices are available in addition to others: ICP/AES, ICP/MS, AAS, GC/MS, GC/ FID, LC/MS, HPLC/DAD, IC, potentiometry etc. OUR QUALITY STANDARDS The primary aim of our activities is quality. Our extensive certifications and accreditations mean that our work is subject to continuous controls by national and international inspectors. GMP certification • Stability studies • Testing of pharmaceuticals • GMP approval for operation and BASG certification in accordance with EU Directives 2001/83/EC, 2001/20/EC, 2003/94/EC and the Medicines Act and the Pharmaceutical Regulations 2009 ContaCt GLP certification • GLP BASG certification in accordance with the OECD Principles and EU Directives 2004/09/EC and 2004/10/EC Accreditation in accordance with EN ISO/IEC 17025 Seibersdorf Labor GmbH Pharmaceuticals 2444 Seibersdorf, Austria ROLAND MÜLLER, PhD Tel. : +43(0) 50550 - 3470 (Secretary) Fax: +43(0) 50550 - 3473 E-mail:[email protected] Web:www.seibersdorf-laboratories.at/pharma-service Seibersdorf Labor GmbH · v16062014 · © 2014 Certification EN ISO 9001