Good Laboratory Practice (GLP) is a quality assurance system that deals with the organisational process and framework conditions of non-clinical health and environmental safety testing of substances and with the recording, archiving and reporting of such tests. It must be applied, complied with and verified on an ongoing basis.
Competence of the BAES
According to the amendment of the Austrian Regulation BGBl. I No. 58/2017 on the Chemicals Act 1996, the Federal Office for Food Safety (BAES) is responsible for monitoring compliance with the principles of good laboratory practice (GLP). The Institute for Monitoring of the Agency for Health and Food Safety (AGES) can be contacted at firstname.lastname@example.org or by telephone at +43 (0)50 555-36435.
The Chemicals GLP Inspection Ordinance transposes the following two EC Directives into national law.
- Directive 2004/9/EC on the inspection and verification of GLP obliges Austria to comply with the OECD monitoring and inspection procedures as well as with international reporting on test facilities and inspection results.
- Directive 2004/10/EC requires the application of the principles of GLP and the control of their application in tests on chemical substances. The two Directives form the basis for the Mutual Acceptance of Data System (MAD) of the OECD.
The GLP principles of the OECD, interpretive documents on selected topics, as well as the member states of the MAD are listed here. In addition, the European Commission (EC) lists on its website the countries with which it has concluded a data recognition agreement.
Mutual Data Recognition in the Mutual Acceptance of Data System (MAD)
Austria is a member of the MAD. Thus, all health and environmental non-clinical safety data generated in Austria can be recognized by all other member states of the MAD. Conversely, Austria recognises data of this type from other MAD member states. The prerequisite is a valid GLP certificate issued by BAES and proof from the test facility or sponsor that a relevant non-clinical safety trial has been conducted in accordance with the principles of GLP.
GLP certification by the BAES
The GLP certificate of a test facility issued by BAES refers to one or more Areas of Expertise to which the non-clinical safety trial/non-clinical safety trials are assigned (the Areas of Expertise are harmonised activity designations of the OECD according to Annex III to OCDE/GD(95) Guidance for GLP Monitoring Authorities for the Preparation of Annual Overviews of Test Facilities Inspected). If an Austrian testing institution is considering a new type of test outside the Areas of Expertise, this intention must be communicated to BAES and the appropriate steps taken.
The basis for issuing a GLP certificate is exclusively the Austrian legal situation. Standards from other countries, in particular from third countries, cannot be taken into account. GLP test facilities are solely responsible for compliance with foreign legal requirements and must not adversely affect conformity with national regulations.
An active GLP test facility is periodically inspected; the GLP certificate is issued by the BAES after the initial inspection for the duration until a new inspection. Routine follow-up inspections of a test facility shall be carried out at intervals of two years where possible. In addition, additional test facility inspections or study audits may be carried out as necessary, in particular at the request of an authority, for example in response to queries arising from the submission of data to an approval authority. The evaluation bases of the inspection are the quality assurance system and selected ongoing or completed non-clinical health and environmental safety tests of substances that are representative of the Areas of Expertise.
International reporting on test facilities
The national GLP test facilities, their quality status, the areas of expertise and the type of inspection carried out are transmitted once a year (cut-off date is always 31 March of the following year) from BAES to the European Commission and the OECD. This information about the Austrian GLP testing facilities can be obtained on request from BAES. The collected internet addresses of all GLP Monitoring Authorities of the MAD are publicly available on the OECD website. An active information process is being conducted between the member countries of the MAD and with the involvement of the OECD and the European Commission, which is immediately started if the inspection results are critical. This can be triggered by the non-conformity of a test facility or the non-conformity of a non-clinical safety study, with expected effects on data quality. The aim of the information procedure is to exclude non-GLP compliant data as a basis for decisions on marketing authorisation applications in order to prevent risks to humans or the environment.
Forms (change of inspection body management, termination of activity)
- docxForm Notification of change of control centre management GLP (this form is only available in German)
Notification of the change in the management of the GLP testing laboratory pursuant to §§ 21 para. 6, 51 and 52 of the Chemicals Act 1996 - ChemG 1996 and the Chemicals GLP Inspection Ordinance of the Federal Ministry of Agriculture, Forestry, Environment and Water Management as amended.
- docxForm Message Termination Activity GLP (this form is only available in German)
Notification of the intended termination of activity as a GLP testing laboratory pursuant to Sections 21 (6), 51 and 52 of the Chemicals Act 1996 - ChemG 1996 and the Chemicals GLP Inspection Ordinance of the Federal Ministry of Agriculture, Forestry, Environment and Water Management as amended.