1. The Good Laboratory Practice or GLP is a quality system that reviews a research laboratory’s process and conditions in which its non-clinical studies are planned, performed, monitored, recorded, reported and archived. The system can be applied to the risk assessment of chemicals for registration of products.
2. In Singapore, the relevant registration authorities are the
- Health Sciences Authority (HSA) for pharmaceuticals industry
- Agri-Food and Veterinary Authority (AVA) for veterinary biologics and agricultural chemicals
- National Environment Agency (NEA) for pesticides and industrial chemicals
3. The basic document dealing with the GLP is the Organisation for Economic Co-operation and Development or OECD Principles of Good Laboratory Practice, which is produced by the OECD GLP Working Group. More information on this is available at www.oecd.org/ehs. These OECD GLP principles prescribe the roles of the
- Study director,
- Quality Assurance unit,
- Documentation of standard operating procedures,
- Content of study plans and reports and
- Way in which all data related to each study is archived.
4. The GLP programme was announced in June this year. Since then SPRING Singapore has been working closely with the AVA, Economic Development Board or EDB, HSA and NEA to develop the programme. The programme is managed by SPRING and is now open for application.
Objectives of the GLP programme
5. The GLP promotes the quality and validity of test data and ensures that test results are reliable and repeatable. In addition, the programme ensures that studies are auditable so that they can be reconstructed in their entirety from the archived data at a later stage.
6. Although GLP covers processes and conditions under which non-clinical studies are planned, performed, monitored, recorded, reported and archived, it does not guarantee that the scientific interpretation of the study data for a test substance is valid, eg, the efficacy of a novel drug.
7. To help Singapore stay at the forefront of biomedical sciences and develop a biomedical hub, it is critical for us to have a GLP programme. This is because currently, research data from non-clinical studies in Singapore is still not accepted in many developed countries, including the 30 OECD countries. Therefore, we need to adopt the GLP principles to be part of the OECD’s Mutual Acceptance of Data (MAD) system.
8. MAD was established in 1981 under an OECD Council Act stating that data generated in an OECD Member country in accordance with OECD Test Guidelines and Principles of Good Laboratory Practice (GLP) will be accepted in other Member countries for assessment purposes and other uses relating to the protection of human health and the environment.
9. Although Singapore is not an OECD country, we announced in June 2006 that we will unilaterally accept data from OECD countries and other non-member countries of MAD. We intend to work towards MAD membership by 2008 for acceptance as a non-member OECD country.
10. Once Singapore is accepted into OECD’s MAD membership, research from GLP-compliant companies in Singapore will be accepted in any of the 30 OECD countries, such as Australia, Japan, UK and US. Any facility claiming to be compliant with the GLP principles must be assessed by SPRING before it can gain GLP recognition.
About the GLP Programme
11. The GLP programme is applicable to research laboratories in the pharmaceutical, pesticides, veterinary drug products and industrial chemicals industries as well as contract research organisations. Contract research organisations provide research services for multinational corporations or MNCs which may not have their own research departments.
12. The GLP principles can be applied to the conduct of non-clinical health and environmental safety studies of products such as pesticides, cosmetics, pharmaceutical or drugs, food and feed additives, and industrial chemicals. Non-clinical studies cover physical-chemical testing, toxicity studies, environmental toxicity, residue studies, and the analytical chemistry studies.
13. The programme does not include the conduct of clinical studies such as pharmacokinetic and efficacy studies. However, some registration authorities may require a demonstration of the quality of test data from clinical studies. In Singapore, this is best demonstrated by the testing laboratory accredited under the Singapore Laboratory Accreditation Scheme or SINGLAS in areas such as medical testing or chemical and biological testing.
14. Participation in the SPRING’s GLP programme is voluntary. Companies in the relevant industries are encouraged to apply for GLP registration to gain access to countries, especially those within European Union, which require that any non-clinical studies have to be conducted in compliance with the GLP principles.
Benefits of GLP Registration
15. GLP registration is an assurance to regulatory authorities that the data from research laboratories are a true reflection of the study results and are thus reliable for making risk/safety assessments. One key benefit is of course, greater access to international markets, avoidance of expensive duplicative safety tests and reduced time to market for new products. Consumers will also benefit, knowing that new drugs and products have undergone rigorous safety and environmental testing.
16. In addition, the GLP programme will play a major role in promoting research and development (R&D) in cosmetics, veterinary drugs, food and feed additives. More importantly, it will help Singapore develop into a world-class biomedical hub.
17. A facility seeking recognition for compliance with the GLP principles should apply to SPRING, stating its proposed scope of recognition and type of studies. It will have to provide key information covering the following areas :
- Management structure
- Key responsibilities of the personnel and units
- Information on names of Study Director, Study Sponsor
- Persons in charge of Quality Assurance and the Archive
- Quality manual and standard operation procedures, among other documents
18. SPRING will do a documentation review before the on-site assessment, which is done to determine compliance with the GLP principles. The facility must also have completed at least one GLP-compliant study before the assessment. This study will be used as the basis for the on-site assessment.
19. The on-site assessment will be done by a staff from SPRING who may be accompanied by technical experts in various fields as decided by SPRING. Assessment may take one to five days, depending on the scope and size of the facility. Reassessments will be conducted every two years and a study audit will be done annually.
20. Once a facility has satisfied all criteria in accordance to the GLP principles, SPRING will issue a Certificate of Registration to the facility, detailing the types of studies for which it is GLP-compliant. The total time taken for a facility to be registered can range from three to six months depending on the type and nature of the studies, as well as the results of the assessment.
21. The cost of a typical GLP registration process, including the application, documentation review, facility inspection, study audit and annual certificate fee is estimated to be $7,500.
22. Enterprises or laboratories who are interested in the GLP programme can contact Ms Chin Poh Yin, Head, Laboratory, Accreditation Division, on tel: 6279 1859 or email: firstname.lastname@example.org
23. Download the GLP FAQs. (WORD format, 44.5kB)