Project example >> Consulting and supporting introduction of a QM-system according to GLP.

Good laboratory practice (GLP) is a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.

The OECD principles of Good Laboratory Practice are defined in Annex I of the European directive 2004/10/EC.

Carag accompanied the introduction of a quality management system compliant with the principles of good laboratory practice. It supported its customer in developing the QM handbook and the corresponding standard operating procedures and forms in compliance with GLP. Carag guided him through the audits up to the successful confirmation of GLP conformity by the notified body.

The customer, HIK-Hannover, Germany, produces high quality histological sections from implants, soft tissue and bones for microscopic analysis.