NAB-MALTA is the National Monitoring
Authority responsible for verifying compliance with the principles of Good
Laboratory Practice of any testing laboratory in Malta, claiming to use Good
Laboratory Practice under L.N. 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 evironmental 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 concering 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 2004/09/EC
and 2004/10/EC
of the European Union. The
implementation of the aforementioned European Directives in Malta is
established in L.N. 371 of 2004.
MEETING & APPLICATION
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 principlesand 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 outat 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 type 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.