Diagram the operating areas of Quality Assurance and Management by Targos

Quality Assurance and Management

Patient care and safety are our guiding principles in quality management.

The Targos quality management programme is designed to produce the highest quality service to our customers in accordance with international accreditation standards such as Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), DIN EN ISO 9001 / DIN EN ISO/IEC 17025/17020  as well as legal requirements and instructions of professional associations.

Analytical procedures are validated according to ICH Q2(R1) guidelines and the FDA guidance for “Bioanalytical Method Validation”. Computerized systems are validated according to the requirements of EU GMP guideline 2003/94/EC and FDA guidelines 21 CFR Part 11.

Our quality management programme steers the successful application of standardized procedures for all involved process steps, which include e.g. contracting and documentation, sample reception and processing, sample staining and evaluation or data management. Regular quality control by internal audits of all processes and projects and the participation in external proficiency testing programs (e.g., US-CAP, CLIA, NordiQC, QUIP), together with many other measures (see illustration) have been the basis for many years of inspections by the authorities (FDA, US-CAP) without significant findings.​