GMP Compliant & Accredited
Sigma Analytical Services holds a Drug Establishment License and offers services under a GMP certified quality management system. Sigma’s quality management system can satisfy the requirements of Health Canada, FDA, and European Medicines Association.
Sigma’s GMP certification is valid and approved in Europe as well under the Mutual Recognition Agreement between Canada and the European Union (EU). Sigma also holds a GMP clearance from Australia’s Therapeutic Goods Administration (TGA).
A Quality Management System provides the infrastructure for housing an organization’s policies, processes, documentation and includes the required procedure on the resources that are needed to be followed.
GMP accreditation provides assurance that the lab follows and maintains its current and compliant Quality Management System in order to have a rigorous control over the processes that ultimately ensure integrity, accuracy, and reliability of analytical testing data and final test results.
Testing under a GMP-compliant and certified system helps clients ensure that the products they manufacture and release are of consistently high quality.