GLP (Good Laboratory Practice) verification
Good laboratory practice (GLP) is defined by the OECD as “a quality system concerned with the organizational process and the conditions under which non-clinical and environmental safety studies are planned, performed, monitored, recorded, archived and reported.” The principles of good laboratory practice apply to safety testing in laboratories, which are required for test items to be contained in pharmaceutical products or parts thereof. GLP is a harmonized quality assurance system used worldwide to ensure comparability and reliability of inspections.
Responsibility in Austria
The responsibility for monitoring good laboratory practice (GLP) in Austria is shared between two authorities:
Non-clinical safety studies for drug substances lies within the responsibility of the Federal Office for Safety in Health Care (BASG). The Institute Surveillance of the Austrian Medicines and Medical Devices Agency (Agency for Health and Food Safety, AGES) is executing the GPL Monitoring on behalf of BASG.
Any other test facilities that perform non-clinical safety studies (e.g. in the field of plant protection products, biocides, cosmetics, veterinary medical products, food additives, feed additives, and industrial chemicals) are monitored by the Federal Ministry for Agriculture, Regions and Tourism (BMLRT).
Confirmation of assessment is provided by a certificate, containing the following text: „Quality Austria hereby verifies that the laboratory’s quality assurance system complies with the principles of Good Laboratory Practice (GLP)." However, this does not replace certification against the GLP Program by the Federal Office, but provides a good preparation for it!
- Ensuring process quality and documentation
- Compliance with the principles of Good Laboratory Practice
Test facilities, pharmaceutical industry, research laboratories
- Organization / personnel
- Quality assurance program
- Premises / facilities
- Devices / material
- Test items and reagents
- Standard operating procedures (SOPs)
- Performance of the study
- Storage and retention
GMP, GDP, GCP