Standards Malaysia Good Laboratory Practice Compliance Programme (GLP CP)
1. Definition of Good Laboratory Practice
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, reported and archived. Having GLP recognition does not affirm the technical validity of these studies. The studies are undertaken to generate data by which hazards and risks to users, consumers and third parties, including the environment, can be assessed for pharmaceuticals, pesticides, and cosmetics, veterinary drugs, feed additives, food additives and industrial chemicals. GLP helps assure regulatory authorities that the data submitted are true reflection of the results obtained during the study and can therefore be relied upon when making safety assessments.
2. How can I apply for a GLP certificate?
For all test facilities established in Organisation for Economic Co-operation and Development (OECD) countries, you should contact the national GLP Monitoring Authority responsible for the scope of your studies.
For test facilities established in Malaysia, you should contact us as address below or National Pharmaceutical Control Bureau, Ministry of Health at www.bpfk.gov.my.
Department of Standards Malaysia
Level 1 & 2, Block 2300
63000 Cyberjaya, Selangor, Malaysia
Tel : +(603) 83191317/1377/1369 Fax : +(603) 8318 933
Website : http://www.jsm.gov.my
3. What is the difference between GLP recognition and ISO/IEC 17025 accreditation?
GLP is about recognition of a quality system that has organisational processes and conditions that in accordance with OECD criteria. ISO/IEC 17025 accreditation is a formal recognition for technical competence to undertake specific tests or calibrations. In general GLP is used for non-clinical health & safety studies that are often called for in regulations while ISO/IEC 17025 accreditation is used normally voluntary. Laboratory accreditation to ISO/IEC 17025 is for routine testing and measurement while GLP is anon-routine work covers under the non-clinical safety studies. Examples of non-routine work may include dosing animals or spraying fields. Only OECD GLP compliance can provide an effective quality system that gives regulators the necessary confidence in relation to how non-clinical health and safety studies are planned, performed, monitored, recorded, reported and archived.
OECD position on ISO 17025 vs GLP
OECD position on ISO 17025 vs GLP
4. What are the OECD Principles?
OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, published by OECD's Environment Directorate, and most recently revised in 1998. This document is produced by the OECD GLP Working Group and is available at OECD website (www.oecd.org)
The basis for the development of GLP was to provide assurance of data safety regarding test item data from non-clinical studies related to the hazard assessment of chemicals (pharmaceuticals, veterinary and agricultural chemicals, pesticides etc) when manufacturers are seeking to register products for use.
5. Is a quality manual required in GLP?
Depends on the test facilities operation but Standard Operating Procedures is required in GLP Principles.
6. Where do I apply the GLP Studies?
The Principles of GLP are applied to studies conducted for non-clinical health and environmental safety studies of test items contained in various chemical products. A study covers work done in a laboratory, animal house, greenhouses and in the field. Non-clinical studies may cover physical-chemical testing, toxicity studies, mutagenicity studies, environmental toxicity on aquatic and terrestrial organisms, studies on behaviour in water, soil and air; bioaccumulation, residue studies, studies on effects of mesocosms and natural ecosystems and the analytical chemistry associated with such studies.
GLP is a quality system concerned with the organisation process and conditions under which the non-clinical studies are planned, recorded, archived and reported. The Principles are prescriptive and also covered the roles of the Study Director, Quality Assurance Unit, Documentation of Standard Operating Procedures, the content of study plans and reports and the way in which all data related to each study is archived.
7. What are the scopes covered within Standards Malaysia Compliance Program?
GLP CP is a voluntary program open to test facilities conducting studies for non-clinical health and environmental safety studies and for purpose of registering and/or licensing on test item contains in product in the following categories:
- Industrial Chemicals
- Feed Additives
- Biotechnology (non-pharmaceuticals)
* Except for studies conducted test item contain in product such as pharmaceuticals, cosmetics, food additives and veterinary drugs will be inspected by National Pharmaceutical Control Bureau, Ministry of Health (NPCB , MoH).
8. What is the required information for submission to Standards Malaysia?
A test facility seeking recognition for compliance with the OECD GLP Principles should apply to Standards Malaysia, stating its proposed scope of recognition and type of studies. It will have to provide key information such as Master Schedule of Studies, Floor Plan, Organisation and Test Facility Structure, Key responsibilities of the personnel and units, Information of Study Sponsor, Curricular Vitae of test facility/ Personnel, Quality Manual, Standard Operation Procedures Structure and others relevant document.
9. What is the mechanism for entering the program?
In Malaysia, GLP is a voluntary scheme. There are two mechanisms by which a test facility will enter into the program:
- By submitting application to Standards Malaysia; or
- Through request of inspection received from national or international authority. The test facility will be invited to submit the application form.
- In both cases the test facility shall be entered into Standards Malaysia Compliance Program only after the test facility has received GLP compliance.
10. Is this program mandatory?
In Malaysia, GLP CP is a voluntary program open to test facilities conducting studies for non-clinical health and environmental safety studies and for purpose of registering and/or licensing on test item.
However in some countries, particularly those within European Union it is required by law that any non-clinical studies are to be conducted in compliance with the OECD Principles of GLP.
11. What is Mutual Acceptance of Data (MAD)?
MAD is an OECD Council Act established in 1981 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. Although Malaysia is not an OECD country, it has in 2006 announced that it will unilaterally accept data from OECD countries and other non-member countries of MAD. It intends to work towards MAD acceptance in 2007 for acceptance as a non-member OECD country.
12. What is the difference between a deviation and an amendment?
Deviations are unplanned deviations from the study plan e.g. problems that occurred during the executing of certain experiments. Deviations are noted and acknowledged in a timely manner to the study director and signed by him/her. Planned deviations should be made under the form of an amendment of the study plan.
13. Who can benefit from GLP recognition?
Companies that can benefit from GLP registration include:
Research laboratories in the pharmaceutical, pesticides, veterinary drug products and industrial chemicals industries
Contract research organizations
For further information on OECD Good Laboratory Practice, please visit this link: OECD FAQs