Purpose
Public health and environmental protection can only be attained when there is a concerted effort to assure that both scientific validity and data quality standards are fulfilled when executing a study. For example, a study that is planned according to valid scientific principles cannot assure the safety of a chemical or biological product when it is poorly conducted and inadequately documented. Likewise, a properly executed and documented study is of little value to regulatory scientists if the design is flawed.
Scientific validity of a non-clinical safety study can be assessed during the pre-marketing or pre-manufacturing review, which is part of the process for registration or notification of chemical and biological products. However, the assessment of the data quality and integrity can only be done at the facility where the study was conducted, with the facility personnel and study records.
Scope
Standards for the scientific validity are established through the development of OECD Test Guidelines or other internationally recognized scientific standards. Data quality and integrity are assured by compliance with the OECD Principles of Good Laboratory Practice (GLP) and by national GLP Compliance Monitoring Programmes which implement the guidance established by OECD.
The GLP Compliance Monitoring is intended to ascertain whether test facilities claiming GLP compliance for a study have implemented fully the GLP principles for the conduct of studies and are capable of assuring that the resulting data are of adequate quality. Inspections may be conducted at any test facility, situated in Belgium and generating health and environmental safety data for regulatory purposes. It is the obligation of each test facility claiming GLP compliance to prove that their GLP studies are planned, monitored, performed, reported and archived according to the OECD Principles of GLP.
Unless specifically exempted by national legislation, these Principles of Good Laboratory Practice apply to all non-clinical health and environmental safety studies as required by regulations for the purpose of registering or licensing of:
- Pharmaceuticals
- Pesticides
- Food additives
- Feed additives
- Cosmetic products
- Veterinary drug products and similar products
- Biocides
- Industrial chemicals
These test items are frequently synthetic chemicals, but may be of natural or biological origin and, in some circumstances, may be living organisms. The purpose of testing these test items is to obtain data on their properties and/or their safety with respect to human health and/or the environment. Non-clinical health and environmental safety studies covered by the Principles of Good Laboratory Practice include work conducted in the laboratory, in greenhouses, and in the field.
See also the Comparison of GLP with ISO 17025.
Legislation
The application of Good Laboratory Practice in safety testing of chemicals is required by Directives 2004/09/EC and 2004/10/EC of the European Union. The implementation of those European Directives in Belgium is laid down in the Royal Decree of 6 March 2002.
Sciensano—a governmental, non-profit organisation—has been designated as the Belgian GLP Monitoring Authority for GLP compliance assessment by the Royal Decree of 27 October 1988, (modified by the Royal Decree of 6 March 2002). The GLP Monitoring Authority is a unit of the Quality, (bio)Safety & Environment service, which is part of the general management. It consists of the General Director of Sciensano, the GLP coordinator and different GLP inspectors. According to European Directive 2004/09/EC, art. 2, when the results of an inspection are satisfactory, the General Director of Sciensano may provide an endorsement of a claim that a laboratory and its tests comply with GLP.
Belgian GLP Compliance Monitoring Programme
Test facilities who want to introduce a request for the verification of their compliance with the GLP-principles should address their request to the General Director of Sciensano. Contact the GLP Coordinator for more information.
The test facilities embodied in the master schedule of the GLP Compliance Monitoring Programme are monitored on a two to three year cycle. The programme includes pre-inspections, Test Facility inspections, Study Audits, follow-up inspections, and re-inspections. Pre-inspections are carried out if the test facility has to be inspected for the first time. During the Test Facility Inspection, not only the organisation of the test facility but also on-going and completed studies are verified. Re-inspections are carried out if deviations have been found during the routine inspection for which the corrective actions have to be verified. A test facility that is new in the programme will receive a follow-up inspection within 18 months after the first inspection.
On this website you will find a list of Belgian GLP Test Facilities with their scope and area of expertise. More detailed information can be found in the GLP Compliance Monitoring Programme Manual.
Inspections in non-MAD countries
Because studies are conducted and submitted throughout the world it is difficult and expensive for a monitoring authority to perform inspections and audits of studies conducted outside its country or economy. Consequently, confidence in other GLP Compliance Monitoring Programmes is crucial to supporting pre-marketing (pre-manufacturing) evaluation and for assuring public health and environmental protection. The adherence to OECD Council Acts related to Mutual Acceptance of Data (MAD) in the Assessment of Chemicals was opened to economies which are not Members of the OECD (“non-Members”) in January 1998 [C(97)114/FINAL].
Study audits can be done case by case in test tacilities situated in non-MAD countries on request of an European Regulatory Authority (EMA, EFSA, ECHA). Exceptionally, inspections of a test facility situated in non-MAD countries can be done on request of a sponsor. In this case the sponsor has to prove the intention to register a chemical, tested in this test facility, at a European agency. After inspection, this test facility can be included in the Belgian Monitoring Programme on their request for further regular inspections. A certificate can also be given. Inspections in a non-MAD country have to be self-supporting and fees will be calculated according to the time spend. To guarantuee independency, there will be no refund if no certificate can be provided due to the outcome of the inspection, reasons of not fully complying with the GLP principles, rejection of a study or conflicts with the inspection team.
An inspection in a non-adherent OECD member economy will not guarantee that, even if the test facility has a certificate of GLP compliance, their data will be accepted automatically in the member countries. Each receiving authority may still decide to send additional GLP inspectors to verify the accuracy of the compliance statement for a specific study.