Quality Assurance at SGS M-Scan
Good Laboratory Practice (GLP) and current Good Manufacturing Practice (cGMP)
SGS M-Scan is committed to maintaining the highest quality analytical services. Our facilities are governed by Standard Operating Procedures (SOPs) with all equipment being appropriately qualified. Methods can be validated to satisfy regulatory demands. Final reports are quality controlled by scientific peer-review, in addition to Quality Assurance Unit review for regulatory studies. Upon arrangement, clients are welcome to conduct their own audit. For regulatory submissions or product release testing, services are conducted in accordance with defined GLP or cGMP regulations.
SGS M-Scan Ltd - GLP / cGMP compliant and FDA inspected.
SGS M-Scan Ltd has been inspected biennially, since 1992, by the UK Department of Health, Medicines and Healthcare products Regulatory Agency (MHRA) GLP Monitoring Unit. SGS M-Scan Ltd has also been inspected by the FDA and confirmed GMP compliant by the MHRA. In a new initiative, the MHRA has introduced a 'certificate of GMP inspection' and SGS M-Scan Ltd was one of the first laboratories to receive this.
SGS M-Scan Ltd also holds a Home Office Drugs License in the United Kingdom.
2010 GLP Compliance Statement (Directive 2004/9/EC).
2010 GMP Compliance Certificate (Part 1, Part 2)(Directive 2003/94/EC)
SGS M-Scan SA - GLP / cGMP compliant and FDA inspected.
SGS M-Scan SA has been certified to perform GLP and cGMP analysis by the Swiss Agency for Therapeutic Products, Swissmedic and has been successfully inspected by the FDA.
2008 Statement of GLP Compliance (Art.14 para.3 Ordinance on GLP [RS813.211.1])
2008 Certificate of GMP Compliance
SGS M-Scan Inc - cGMP compliant and FDA inspected.
SGS M-Scan Inc performs analyses under cGMP regulations (21 CFR Parts 210 and 211) and has been successfully inspected by the FDA.
The latest inspection held in February 2009 resulted in no Form 483 observations.
SGS M-Scan Inc. has been audited by the US Drug Enforcement Administration (DEA) and is licensed to perform analytical testing services on controlled substances in schedules 1, 2, 3, 3N, 4 and 5.
SGS M-Scan GmbH - GLP and cGMP compliant.
SGS M-Scan GmbH has been inspected and certified to perform cGMP analysis by the Leitstelle Arzneimittelüberwachung Baden-Württemberg.
SGS M-Scan GmbH has been inspected and certified to perform GLP analysis by the Landesanstalt für Umwelt, Messungen und Naturschutz Baden-Württemberg.
Certificate of GMP compliance 2008 (§14 para 4 No.3, German Drug Law (AMG))
Statement of GLP Compliance 2009 (§19b Chemikaliengesetz and Directive 88/320/EEC)
Quality Assurance Unit: Dr F Greer is the Director of Quality Assurance for all laboratories. Mr J Mallard, Mrs K Mallard and Ms A. Di Matola and Ms A. Gaiger comprise the Quality Assurance Unit overseeing SGS M-Scan Ltd, SGS M-Scan SA and SGS M-Scan GmbH. Ms S Sladen is the SGS M-Scan Inc Quality Assurance Manager assisted by Ms L. Yannella.