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การรับรองห้องปฏิบัติการทดสอบหรือศึกษาวิจัย/พัฒนา

   

Requirements and Conditions for GLP compliance test facility
Bureau of Laboratory Quality Standards, Department of Medical Sciences

     Rev. No. 01

     Bureau of Laboratory Quality Standards (BLQS) is responsible for registration of test facility regarding all public health (health products) and medical studies. This is in accordance with the situations and policy of the country to allow the government and private sectors to be able to issue the study results of health and bio-product research including research laboratory development to meet the OECD Principles of Good Laboratory Practice which leads to export promotion and public health services throughout the country. The OECD Principles of Good Laboratory Practice are designed to apply to test facilities carrying out health and environmental safety studies on chemical substances where the results are to be submitted to Regulatory Authorities (national or international bodies with legal responsibility for the registration and licensing of chemicals).

 

1. Scopes

      The GLP Compliance Programme is voluntary. This programme monitors test facilities conducting studies for non-clinical health safety studies on test item contained in products in the following categories:
• Pharmaceutical products (include bioequivalence studies);
• Cosmetic products;
• Veterinary drugs;
• Food additives;
• Household chemical products.
The testing of these items is for the purpose of obtaining data on their properties and/or safety with respect to human health.

 

2. Definitions

      Registration : Procedure by which the BLQS, DMSc gives formal recognition that the test facilities has the management comply with the OECD Principles of Good Laboratory Practice and the BLQS requirements.
      Test facility : The persons, premises and operational unit(s) that are necessary for conducting the non-clinical health and environmental safety study.
      BLQS : Bureau of Laboratory Quality Standards, Department of Medical Sciences, Ministry of Public health
      Health products: Food, pharmaceutical products, cosmetics, medicinal herbs, household chemical products, biological products, radiation and medical devices. 
 

3. Qualification of the test facility applicants

      3.1 The test facility must be legal identifiable. The test facility may comprises permanent test facilities, with or without sites away from its permanent.
      3.2 The test facilities shall have completed at least one study that has been conducted in compliance with the OECD Principles of Good Laboratory Practice. 
 

4. Requirements

      4.1 The test facility shall implement the management system according to the OECD Principles of Good Laboratory Practice. Associated consensus and advisory documents should be implemented as applicable.
      4.2 The top management of the test facility or the authorized representative shall sign the application.
      4.3 Each applicant must nominate a senior staff member to represent it in dealing with BLQS, DMSc. The Authorized Representative may be a senior technical or managerial staff who holds an appropriate position in the organization with the authority to ensure their facility complies with the criteria for registration at all times. The Authorised Representative is expected to be present at inspection entry and exit meetings.
      4.4 The application shall be submitted with the detail of the GLP management system and the implementation document, which can fulfill the requirements of the BLQS. The controlled release of such documentation to BLQS is the responsibility of the facility wishing to enter the BLQS GLP compliance Programme. The BLQS will terminate the application if the documents are not completed within 180 days, after the date of submitting the application, where appropriate.
      4.5 The test facilities shall comply with the registration procedure and shall pay fee schedule as scheduled and conditioned by the BLQS, DMSc.
      4.6 The test facility shall corporate with the inspectors in the following;
             4.6.1 Permit the access to the premises, facilities, resources, operations, procedures, records and staff.
            4.6.2 Prepare for the evidences during on-site inspection according to the request of the inspectors, including the hand on analysis for witness.
            4.6.3 Prepare the test sample and evidence for the inspection.
            4.6.4 Provide the room for examination of document, the meeting of inspector team and other activities.
            4.6.5 Assist and allow the use of the office stationary and the communication apparatus as necessary. 
                                          

5. OECD Publications

     Testing facilities registered as being GLP compliant are inspected directly against the requirements of the following OECD Environmental Health and Safety Publications from the Series on Principles of Good Laboratory Practice and Compliance Monitoring:
      (a)Number 1: The OECD Principles of Good Laboratory Practice (1998)
      (b) Number 4: GLP Consensus Document - Quality Assurance and GLP (1999)
      (c)Number 5: GLP Consensus Document - Compliance of Laboratory Suppliers with GLP Principles (1999)
      (d)Number 6: GLP Consensus Document - The Application of the GLP Principles to Field Studies (1999)
      (e) Number 7: GLP Consensus Document - The Application of the GLP Principles to Short-Term Studies (1999)
      (f) Number 8: GLP Consensus Document - The Role and Responsibilities of the Study Director in GLP Studies (1999)
      (g) Number 10: GLP Consensus Document - The Application of the Principles of GLP to Computerised Systems (1995)
       (h)Number 13: Consensus Document of the Working Group on Good Laboratory Practice – The Application of the OECD Principles of GLP to the Organisation and Management of Multi-Site Studies
      (i) Number 14: Advisory Document of the Working Group on Good Laboratory Practice – The Application of the Principles of GLP to in-vitro Studies
      (j) Number 15: Advisory Document of the Working Group on Good Laboratory Practice – Establishment and Control of Archives that Operate in Compliance with the Principles of GLP.

Number 1 is the primary or base criteria document against which all GLP compliant test facilities are inspected. These publications are available at no charge at the OECD's web site at http://www.oecd.org/chemicalsafety/testing/  

 

6. Registration

      6.1 The test facility shall submit the application to the BLQS with the evidence of listed document as mentioned in Appendix 1. Test facility will be required to justify their reasons for wishing to enter the GLP Compliance Programme.
      6.2 Upon the acceptance of the application, the BLQS shall proceed as follow:
          6.2.1 Examine the completeness of the documents, then inform the applicant to pay the fee schedule as mentioned in Appendix 2.
          6.2.2 The BLQS shall appoint the inspectors after all of documents is completely for registration procedure.
          6.2.3 Pre-inspection is an optional process, if it is required by the new applicant, the test facility is notified of the date, time, and the inspectors’ name. It normally takes one day for pre-inspection. The inspectors shall assess the management structure, the physical layout of buildings, the documentation system and the ranges of studies of the test facility. The BLQS shall inform the name of inspectors and the date of pre-inspection before conduct the inspection.
          6.2.4 In case that applicant test facility does not request for pre-inspection the process in the item 6.2.3 is omit. The BLQS shall inform the name of the inspection team and the date of the on-site inspection. The inspection takes 2-4 days.
         6.2.5 When a Test Facility Inspection or Study Audit has been completed, the BLQS shall inform the official inspection report to the test facility. If it reveals deviations from the GLP Principles, the facility will be required to correct such deviations and provide evidence to the BLQS. The inspector may need, at appropriate time, to return to the facility to verify that the proposed corrective actions have been effective.
          6.2.6 The test facility shall carried out the corrective action for the deviations in the timescale of the requirements for registration process of the BLQS. The duration for corrective action begins on the date of closing meeting for the inspection. The timescale of corrective action for the deviations from the various inspections are mentioned as following:
                6.2.6.1 On-site inspection, new applicant/extension shall carried out corrective action for the deviations within 90 days. In case that the test facility can not complete the corrective action within 90 days, the test facility can extend the duration of correction in written to the BLQS with the reason and the approximate date for completion of the corrective action, however, the duration of corrective action shall be done within 180 days.
              6.2.6.2 For re-inspection, the test facility shall carried out within 30 days. In case that the test facility can not complete the corrective action within 30 day, the test facility can extend the duration of correction for another 30 days in written to the BLQS with the reason and the approximate date for completion of the corrective action.
          6.2.7 Once a Test facility has satisfied all criteria in accordance to the GLP principles, the BLQS shall issue the certificate of registration detailing the date of the inspection, type of studies for which it is GLP-compliant and shall be included into the GLP Compliance Programme
     6.3 The certificate is valid for 2 years from the issue date. It can be extended for another 2 years if the request for the extension is received by BLQS 120 days prior to the expiry date.
     6.4 The certificate can be issued in English language.
     6.5 If test facility need an extra certificate, payment shall be following as fee schedule in Appendix 2.
     6.6 If the certificate is lost, it can be replaced if the test facility can submit the evidence within 15 days of the incident. Payment shall be following as fee schedule in Appendix 2.
 

7. Actions for registered test facility

     7.1 keep on a management system in compliance with the OECD Principles of Good Laboratory Practice and BLQS, DMSc’s requirements at all time of registration.
     7.2 pays such fees as shall be determined by the BLQS, DMSc. Failure to do so may result in the withdrawal of the registration.
     7.3 must not use the registration to imply approval by BLQS of any product or item from the facility.
     7.4 must not make any statement about its registration to mislead the public.
     7.5 must not use the registration in such a way as to bring BLQS into disrepute.
     7.6 if the registration is withdrawn, the facility must immediately stop making reference to terms “GLP (compliant) facility/laboratory”, “Registered facility/laboratory” or the like, and all advertising materials which contains the terms or refers to them.
     7.7 if any change from the application forms which affect the performances of test facility occur, the BLQS shall be informed within 15 days of the change in following contents:
          7.7.1 legal status or organization status and organization chart.
          7.7.2 loss of key GLP personnel, particularly the GLP management
          7.7.3changes in senior personnel duties and responsibilities (including change of Authorised Representative)
          7.7.4 significant changes in accommodation and/or equipments.
          7.7.5 policy and work procedures in the quality documents.
          7.7.6 others affecting that effect the competence of test facility due to the scope or registration conditions.
     7.8 collection and storage of all quality documents and study reports shall be archived as long as possible or where appropriate.
 

8. Re-Inspection

    The following are other circumstances that may require inspections:
     8.1 Periodic inspection
         8.1.1 Since the certificate of registration has been given for 2 years, Test Facility shall apply for a new one at least 120 days before the expiry date.
         8.1.2 A full inspection will be carried out. The re-inspection is similar in their scope, duration and procedures to initial inspection.
     8.2 Special inspection according to a formal request from a regulatory or receiving authority either in Thailand or from another OECD country through its GLP compliance monitoring authority. Such requests to BLQS would normally arise from a particular study conducted or to be conducted at the facility, and which are intended to or have been submitted to the requesting receiving authority. The scope of such inspection would likely be restricted to an audit of the particular study in question.
     8.3 A physical change in accommodation that necessitates an on-site inspection to verify registration criteria are being maintained or Information is brought to BLQS’s attention which strongly suggests the registered facility is no longer operating in compliance with the GLP Principles.

 

9. Extending scope

    A registered test facility can ask for extending the areas of expertise. BLQS will have to carry out a limited inspection to confirm compliance with the OECD Principles for these areas of expertise. Such an inspection will be chargeable.

 

10. Withdrawal of the registration

    10.1 Withdrawal of the registration
The BLQS will withdraw the registration under the following circumstances.
         10.1.1 The test facility has become bankruptcy by court order.
         10.1.2 Any practice that violate or do not comply with the BLQS’s requirements or do not fulfil GLP Compliant.
         10.1.3 The test facility could not complete a correction within a given time period.
         10.1.4 The test facility is out of business.
         10.1.5 The test facility shall inform the terminated registration by officially document to BLQS, DMSc.

 

11. Appeal

       11.1 The appeal for any decision shall be submitted in writing to the Director General of the Department of Medical Sciences within 15 days after the receipt of the withdrawal letter. The Director General of DMSc will then take appropriate steps to achieve a mutually acceptable resolution. Therefore, he/she may ask for advice of independent internal or external experts and make the decision. The test facility aggrieved by any decision of the Director General of DMSc may make a written appeal to the Permanent Secretary of the Ministry of Public Health within 15 days upon receipt of decision who will appoint three independent persons to review the appeal and make the final decision on behalf of the Ad hoc Appeal Committee. These independent persons will be drawn from the Food and Drug Administration, Ministry of Public Health and /or Department of Agriculture, Ministry of Agriculture and Cooperatives, and / or The Thai Industrial Standards Institute (TISI), Ministry of Industry and /or relevant Professional Association. External experts may be co-operated and when required.
     11.2 The Ad hoc Appeal Committee for Test Facility Registration's decision is a final.
 
12. Use of the terms “GLP (compliant) facility/laboratory”, “Registered facility/laboratory”
     12.1 Test facility shall inform the BLQS of the term compliance statement exhibition.
     12.2 The term compliance statement containing an endorsement from BLQS shall not be abused, misused, or misleading.
 
13. Miscellaneous
     13.1 In case of any amendment or any change of the criteria of registration the BLQS shall inform registered test facilities. The registered facilities shall commit to follow any changes in the criteria and shall adjust its procedures to meet the new requirements within the time frame.
     13.2 The BLQS shall not take any responsibility of the test facility that is not conforming or not abided by the requirements of the BLQS, DMSc.
     13.3 The registered test facility names, typical product and area of expertise and registration number will be announced in the http://blqs.dmsc.moph.go.th.
     13.4 Interested party shall submit the application to BLQS, DMSc within the Ministry of Public Health, Nonthaburi.
 
14. Appendix 1
Documents needed for the registration application
     1. Form 5 Application form for GLP compliance test facility.
     2. Location maps of the test facility and nearby landmark building (2 sets).
     3. Copy of the official company registration bored the authorized personnel names.
     4. Copy of trade registration or the commercial license.
     5. Proxy for the applicant.
     6. Copy of house registration and identification of the applicant.
     7.Form 6 Detail of specific information for GLP compliance test facility.
     8. Form 7 Self evaluation complying with OECD Principles of Good Laboratory Practice.      9. Nomination a senior staff member as a representative in all dealing with BLQS, DMSc.
 
15. Appendix 2

 
Documentation Review Fee Baht 10,000 per one application

Inspection Fee (pre-inspection, on-site inspection, and re-inspection)  

                     Lead inspector Baht 2,000/day
                     Inspector Baht Baht 1,500/day/person

                    Technical expert

Baht 1,000/day/person
Transportation, accommodation and daily allowance where necessary
Registration certificate Baht 25,000/one application
Extension fee for re-inspection Baht 10,000/one re-inspection
Extension fee for extending scope Baht 10,000
Annual fee Baht 2,000
Extra or replacement of registration certificate Baht 2,000

 
 
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