NAB-MALTA is the National Monitoring Authority responsible for verifying compliance with the principles of Good Laboratory Practice (GLP) of any testing laboratory in Malta, claiming to use Good Laboratory Practice under Legal Notice 371 of 2004. However, the NAB-MALTA has signed an agreement with Sciensano, the Belgian GLP Compliance Monitoring Authority.
Definition
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 GLP are followed by test facilities carrying out studies to be submitted to receiving authorities for the purposes of assessing the health and environmental safety of chemicals and chemical products which may also be of natural or biological origin and, in some circumstances, may be living organisms. The principles of GLP define the responsibilities of the Test Facility Management, Study Director, Study Personnel and Quality Assurance Personnel that are operating within a GLP system, and minimum standards concerning the suitability of facilities and equipment to perform studies, the need for standard operating procedures, documentation of raw data, study reports, the archiving of records, etc.
Applicable Regulations
The application of Good Laboratory Practice in safety testing of chemicals is required by the Directives No 2004/09/EC and 2004/10/EC of the European Union. The implementation of the aforementioned European Directives in Malta is established in Legal Notice 371 of 2004.
Meeting and Applications
Test facilities who want to introduce a request for the verification of their compliance with the GLP principles should address their request to the NAB-MALTA. It is recommended to hold a meeting prior to the submission of the application form. During this meeting, the application and requirements will be explained, and the organisation may also ask for any further clarifications. It is recommended that the key personnel responsible for leading the organisation towards GLP, including a representative from the Test Facility Management and the Study Director are present for this meeting. Prior to submitting any application, it is important for the test facility to ensure that it has understood the GLP principles and that its activities fall under GLP. The test facility should check the requirements of the receiving authorities, which is usually one of the following:
The NAB-MALTA will not take responsibility should the pre-inspection or inspection demonstrate that the activities as presented by the GLP facilities cannot be registered under GLP.
Frequently Asked Questions
1. What are the OECD principles of good laboratory practice?
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 GLP are followed by test facilities carrying out studies to be submitted to national authorities for the purposes of assessing the health and environmental safety of chemicals and chemical products, which may also be of natural or biological origin and, in some circumstances, may be living organisms. Depending on the jurisdiction, the Principles of GLP may also be applied to non-clinical safety testing of other regulated products, such as medical devices.
2. What types of tests are carried out at such facilities under GLP?
The OECD Principles of GLP concern non-clinical testing of a chemical or chemical product, examined under laboratory conditions or in the environment, including work conducted in greenhouses and in the field. They do not include studies which use human subjects.
Some examples of studies carried out under GLP include:
- Toxicity studies
- Behavior in water, soil and air; bioaccumulation
- Determination of pesticide residues in food or animal feedstuffs
- Analytical and clinical chemistry testing
- Mutagenicity studies
- Physical-chemical testing
- Environmental toxicity studies on aquatic and terrestrial organisms
- Studies on the effects of mesocosms and natural ecosystems
3. What types of chemicals/chemical products are covered by the OECD principles of GLP?
The OECD Principles of GLP apply to the non-clinical safety testing of test items contained in:
- Pharmaceutical products
- Pesticide products
- Cosmetic products
- Veterinary drugs
- Food additives
- Feed additives
- Industrial chemicals
Depending on the jurisdiction, the Principles of GLP may also be applied to non-clinical safety testing of other regulated products, such as medical devices.
4. How can test facilities become recognised as GLP compliant?
Any test facility that conducts non-clinical health and safety studies (e.g., a university, research institute, private enterprise, government, etc.) can become OECD GLP-compliant or recognised. (This includes facilities in OECD member countries as well as non-OECD economies who become full adherents to the Mutual Acceptance of Data (MAD) system). In most countries, facilities that wish to become recognised as GLP compliant can apply to the government CMP (Compliance Monitoring Programme). The CMP then conducts an inspection to determine if the facility complies with the OECD Principles of GLP.
5. What is the role of the sponsor?
The Sponsor is the identity which commissions, supports and/or submits a non-clinical study. The sponsor should understand the requirements of the Principles of Good Laboratory Practice, in particular those related to the responsibilities of the test facility management and the Study Director. The ultimate responsibility for the scientific validity of a study lies with the Study Director, and not with the sponsor, whose responsibility is to make the decision, based on the outcome of the studies, whether or not to submit a chemical for registration to a regulatory authority.
6. Will Maltese test facilities be included in Sciensano’s inspection programme?
Sciensano will include Maltese facilities in its inspection programme on its website on condition a successful outcome of a full facility inspection including 2 full (mock) GLP study studies.
7. What are the costs of the inspections?
Costs are based on the information provided by Sciensano. The main item of the cost covers the fees payable to Sciensano for the provision of inspectors and administration work related to the specific application.
8. What are the different types of observations raised during an inspection?
- A – Compliance with the Principles of GLP
- B – Minor deviation of the Principles of GLP. This deviation doesn’t influence directly the quality of the GLP system
- B*- Minor deviation of the Principles of GLP. This deviation doesn’t influence directly the quality of the GLP system, but the corrective actions should be justified by documented evidence 30 days after receipt of the provisional report
- C – Major deviation of the Principles of GLP. This deviation is a non-compliance observation regarding the GLP quality system of the Test Facility and/or studies audited
- D – Not applicable
9. What are the timeframes related to GLP inspections?
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.