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FREQUENTLY ASKED QUESTIONS ON GLP THAILAND COMPLIANCE PROGRAMME

 

FREQUENTLY ASKED QUESTIONS ON GLP THAILAND COMPLIANCE PROGRAMME

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. Its principles are required to be followed by test facilities carrying out studies to be submitted to national authorities for the purpose of assessment of chemicals and other used relating to the purpose of man and the environment.

2. How can I apply for a Good Laboratory Practice (GLP) certificate?
For all test facilities established in Organization 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 Thailand, you should contact us as address below:
Director
Bureau of Laboratory Quality Standards (BLQS),
Department of Medical Sciences,
Ministry of Public Health, Thailand.
88/7 Tiwanonth Road,
Nonthaburi 11000, Thailand
Tel: +662 9511270 Fax: +662 9511270
Website: http://blqs.dmsc.moph.go.th

3. How do I get GLP Certification?
A facility seeking recognition for compliance with OECD Principles of GLP should apply to BLQS, stating the proposed scope of recognition, type of studies etc. After submitting the application, Test Facilities will be inspected to determine compliance with the OECD GLP Principles. The Test Facility must have completed at least one GLP-compliant study. Pre-inspection will be carried out if the new test facility requests in an application form. This is then followed by full Inspection once corrective actions have been addressed. BLQS will issue Certificate of GLP Compliance if the Test Facility satisfies the OECD GLP Principles. The Test Facility will then be included in our GLP Compliance Monitoring Program. The Re-Inspection will be conducted every two years after the date of the compliance certificate issued.

4. What is the required information for submission to Bureau of Laboratory Quality Standards?
A test facility seeking recognition for compliance with the OECD GLP Principles should apply to BLQS, stating its proposed scope of recognition and type of studies. It will have to provide key information such as:
a. Location maps of the test facility and nearby landmark building
b. Copy of the official company registration bored the authorized personnel names
c. Copy of trade registration or the commercial license.
d. Nomination a senior staff member as a representative in all dealing with BLQS, DMSc
e. Master Schedule of Studies
f.  Floor Plan
g. List of SOP
h. List of equipments
i.  Organisation Chart
j.  Key responsibilities of the personnel and units
k. Persons in charge of Quality Assurance and the Archive
l.  Curriculum vitae of key personnel
m. Quality Manual, Standard Operation Procedure and others relevant document


5. What are the criteria that a facility must follow?
The facility must first comply with the OECD Series on Principles of Good Laboratory Practice. Other compliance documents include:
a. Quality Assurance and GLP
b. Compliance with Laboratory Suppliers with GLP Principles
c. The Application of the GLP Principles to Field Studies
d. The Application of GLP Principles to Short Term Studies
e. The Role and Responsibilities of the Study Director in GLP Studies
f.  The Application of Principles of GLP to Computerised Systems
g. The Application of the OECD Principles of GLP to the Organisation and Management of Multi-site Studies.
h. The Application of the Principles of GLP to In Vitro Studies
i.  Establishment and Control of Archives that Operate in Compliance with the Principles of GLP
j.  Peer Reviews of Histopathology

6. What is the mechanism for entering the program?
In Thailand, GLP is a voluntary scheme. There are two mechanisms by which a test facility will enter into the program:
• By submitting application to Bureau of Laboratory Quality Standards; 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 BLQS Compliance Program only after the test facility has received GLP compliance.

7. Is the GLP Compliance Monitoring Programme mandatory?
Programme is voluntary. 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.

8. Where can I access the OECD Principles of GLP?
Copies of the OECD Principles of GLP, Consensus Documents and useful guidance documents can be downloaded from the OECD website: http://www.oecd.org/ehs.


9. What is the difference between GLP recognition and ISO/IEC 17025 accreditation?
GLP is a quality system concerned with the organisation process and conditions under which the non-clinical studies are planned, recorded, archived and reported. 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 covers often a series of experiments. Only GLP recognition 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

10. Is a Quality Manual required in GLP?
Depends on the test facilities operation but Standard Operating Procedures is required in GLP Principles.

11. 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.

12. What is the recommended archive period for GLP study records and materials?

The GLP Principles specify the manner in which study materials should be archived but do not specify for how long these items should be retained.
But supporting records should be retained for as long as they may be required in order to support study data. Items that have a limited shelf-life are not expected to be retained beyond their likely usefulness.

 

 

 

 
 
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