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 of professional and ethical 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 is used in biomarker clinical trials for successful application and execution of standardized procedures for all involved process steps, which include e.g., the performance of regular internal audits of processes and projects, the participation in external proficiency testing programs (e.g., CAP, NordiQC, QUIP), CAPA-handling, extensive staff training, supplier qualification, failure & complaint management, consultancy, review of project plans, inspection of documents, SOP and many other processes (see illustration).

 

Explanation of acroynms

CAP: The College of American Pathologists
NordiQC: Nordic immunohistochemical Quality Control
QuIP (Quality assurance initiative of the German Society of Pathology and the Professional Association of German Pathologists for diagnostic immunohistochemistry and molecular pathology)
CAPA: Corrective and Preventive Action