Good Laboratory Practice (GLP)
According to the Austrian Ordinance on Good Laboratory Practice, Federal Law Gazette II 450/2006, the Federal Office for Safety in Health Care (BASG) is a monitoring authority for test facilities that apply GLP principles for the testing of drug substances.
The Institute Surveillance of the Austrian Medicines and Medical Devices Agency is executing the GLP Monitoring Program on behalf of BASG and can be reached by e-mail at glpagesat or by telephone +43 (0) 50555-36435.
Test facilities that test other substances applying the GLP principles are the responsibility of the Federal Office for Food Safety (BAES, www.baes.gv.at). The Ordinance on Good Laboratory Practice is published under http://www.ris.bka.gv.at/.
The Ordinance on Good Laboratory Practice is implementing the following two EU directives into national legislation:
- Directive 2004/9/EC on the inspection and verification of GLP obliges Austria to comply with the monitoring and inspection procedures of the OECD as well as to international reporting of test facilities and inspection results.
- Directive 2004/10/EC requires the application of the GLP principles and the verification of their application for tests on chemical substances.
Both directives are the basis for the mutual recognition system data of OECD (Mutual Acceptance of Data system, MAD). To implement the two directives, a Q & A document is published by the European Medicines Agency.
The GLP principles of OECD, interpretive documents on selected topics, as well as the Member States of the MAD are listed here.
Furthermore, the European Commission (EC) takes on its website to the countries with which it has a data recognition agreement.
Austria is a member of the MAD. In consequence, non-clinical safety data of medicinal products produced in Austria are accepted by all other Member States of the MAD.
The prerequisite is a valid GLP certificate of BASG which is based upon evidence of test facility or the sponsor that a relevant non-clinical testing was performed according to GLP. In return, the Austrian Federal Office for Safety in Health Care (BASG) accepts non-clinical studies to be "GLP compliant", if they are performed in a member state of the MAD, a valid GLP certificate is submitted and there is no evidence that the non-clinical study was not carried out in accordance with the GLP principles.
The GLP certificate of a test facility should refer to the area of expertise of the non-clinical study (the areas of expertise are harmonised categories of the OECD according to Annex III to of OCDE/GD(95)66 Guidance for GLP monitoring Authorities for the Preparation of Annual Overviews of test Facilities Inspected). If a certified test facility is expanding its scope of testing to additional areas of expertise it is advised to get in contact with BASG in order to initiate an inspection in due time, following adaption of the GLP certificate. Otherwise, the affected study would not be covered by the GLP certificate and GLP compliance is not ensured.
The certificate has to cover the entire period during which the non-clinical testing was conducted. Basis for issuing its GLP certificate is documented exclusively Austrian legislation. Standards of other countries, in particular from third countries, cannot be considered. Observance of legal requirements from other States lies exclusively in the responsibility of the GLP test facility and must not interfere with compliance to national requirements. The scope of a GLP-certification may be extended on request to test facilities that perform other than preclinical studies, as long as GLP compliance is a legal requirement for this activity. This may in particular be relevant for test facilities that perform chemical-analytical activities in clinical bioequivalence studies.
The GLP certificate is issued by BASG after initial inspection for a period of up to three years. The extension of the validity requires re-inspection, in consequence an active GLP test facility is inspected periodically at intervals of about two to three years. The re-inspection interval may also be shorter, depending on the results of the previous inspection and risk assessment.
Within BASG, the decision about the acceptance of non-clinical data lies at the units responsible for assessing applications for clinical trials or marketing authorisations. It is not the responsibility of a GLP inspection. The GLP-inspection assesses exclusively the ability of a test facility to apply the principles of GLP, scientific aspects are out of scope. The basis of the GLP inspection is the quality assurance system in accordance with the OECD GLP principles as well as selected ongoing or completed non-clinical studies, which are representatively for the areas of expertise. Without active performance of studies, the BASG is missing part of the basis for its decision-making about the certification. A testing facility that that does not perform studies can therefore not be certified.
Links to the websites of all GLP monitoring authorities of the MAD are published on the website of the OECD. An active exchange of information is maintained between the member states of the MAD, OECD and the European Commission, which is triggered immediately following a critical inspection result. The non-compliance of a test facility or the non-compliance of a study with potential impact on data quality can trigger this exchange. The aim of this alert procedure is to exclude non-GLP data from being used in connection with applications for clinical trials or marketing authorisations in order to to prevent risks to humans.
Non-clinical data that have been generated in a country outside of the MAD are not automatically accepted by BASG to be "GLP-compliant". The recognition would only be possible after a positive inspection result of the study at the site of data creation. The inspection is carried out by inspectors of the BASG. A GLP certificate issued by a member state of the MAD on the basis of an inspection is not recognized by the BASG, if the inspected test facility is located in a country outside the MAD. Such GLP certificates have only relevance for the inspecting authorities and are not equivalent to GLP certificates that are issued by the competent surveillance authority within the MAD.