F 07 15 025
Application form no. 5 (Rev. No.02)
Page 1 of 3 pages
GLP Compliance Monitoring AuthorityBureau of Laboratory Quality Standards
Department of Medical Sciences
Ministry of Public Health
88/7 Tiwanonth Road, Nonthaburi 11000, Thailand /
Application for GLPcompliance test facility
Place......
Date ......
Name of applicant ......
( ) CEO() Authorized representative
Age...... Nationality...... Identification Number......
Issued at ...... Issuance Date ……………………..Expiration date ......
Home Address: ...... ………………………………………………………………………………………
…………………………………………………………………………………………………………………….
Telephone Number: ...... Mobile Number: ……...………..Fax Number: ......
Apply for the test facility/company:
Name: ………………………………………………………………………………………………….………...
Address: ………………………………………………………………………………………………….....
…………………………………………………………………………………………………………......
Business Phone Number: ...... ……….. Business Fax Number: ......
Business ventures: ......
......
Purpose of request:
Registered recognition
(for new applicant: request for pre inspection do not request for pre inspection)
Continuing registered recognition
Extending scope of registered recognition
Type of product:
Pharmaceutical product Cosmetic product
Veterinary drug Food additive
Household chemical product
others (please specify)…………………………………………………………………….
Area of expertise:
Physical-chemical testing Toxicity studies
Mutagenicity studies Residue studies
Analytical and/or clinical chemistry testing
Others (please specify) …………………………………………………………………….
Scope of test orstudy that submitted for theregistration are mentioned in the Application form No.6
Enclose: document (s) needed are as follows:
()Location maps of the test facility and nearby landmark building (2 copies)
()Copy of the company registration bored the authorized personnel names
()Copy of trade registration or the commercial registration
()Proxy for the applicant
()Copy of house registration and identification number of the applicant
()Applicant form no 6. and related documents ……………. copies
()Applicant form no 7.
()Nomination a senior staff member as an authorized representative in all dealing with BLQS, DMSc. The Authorized Representative needs to be a senior staff member who has sufficient authority to ensure that the applicant organization is prepared for assessment and that, following registration, the organization continue to comply with the BLQS criteria (s).
DECLARATION
1)I hereby submit this application for GLP recognition under DMSc Thailand’s GLP programme. As the operator of this test facility, I undertake to ensure that the premise and the studies conducted in the test facility remain in the compliance with the Principles of Good of Laboratory Practice.
2)I hereby commitment to follow the Policy, Requirements and Conditions for GLP compliance test facility and the additional requirements of the BLQS, DMSc.
3)I shall pay all fees and costs connected with the inspection process irrespective of the eventual granting of GLP compliance.
4)I agree toallow BLQS inspectors access to the premises, facilities, resources, operations, procedures, records and staff so that the inspectors can effectively assess the GLP system and activities of my test facility. I understand that the failure to allow the above access will lead to the removal of my test facility registration in the GLP Compliance Programme.
5)I declare that the information given in this application is correct to the best of my knowledge and belief.
Authorized Signature ......
Name (print) ( ...... )