F 07 15 026

Application form no. 6 (Rev. No.00)

Page 1of 6 pages

GLP Compliance Monitoring Authority
Bureau of Laboratory Quality Standards
Department of Medical Sciences
Ministry of Public Health
88/7 Tiwanonth Road, Nonthaburi11000, Thailand /

Specific information for GLPcompliance test facility

  1. Name of test facility/company: ………………………………………………………………

Address: ………………………………………………………………………………………

…………………………………………………………………………………………………

Telephone Number: …………… ………… Fax Number: ………………………………

  1. Nomination a senior staff member as a representative in all dealing with the Bureau of Laboratory Quality Standards

Name: ………………………………………… Position: …………………………………

Address: ………………………………………………………………………………………

…………………………………………………………………………………………………

Telephone Number: …………………………..Mobile Number: …………………………

Fax Number: …..…...………………………...E-mail: ……………………………………..

Name of Quality Assurance Person: ………..…………………Position: ………..…………

Address: ………………………………………………………………………………………

…………………………………………………………………………………………………

Telephone Number: ………………………….. Mobile Number: …………………………

Fax Number: …..…...………………………...E-mail: ……………………………………..

  1. Name and address of test site involved: ………………………………………………………

…………………………………………………………………………………………………

…………………………………………………………………………………………………

  1. Purpose of application

( )For product registration

( )For export

( )a national receiving authority requested that study be conducted in compliance with GLP (please give detail and identify the receiving authority) …………………………………………………………………………………………

( )Others (please specify) ………………………………………………………………..

  1. Scope of test or study

No / Type of sample / Scope of test or study / Principle of test method or study / Method used or type of study/development

Note: additional sheet of paper can be used

  1. Quality Assurance System (please give details and specifytype of inspections made and their dates, including the phase(s) inspected) ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………......
  2. Personnel

Name list of key personnel who engaged in every step of the test or study

Name / Position / Qualification / Responsibility / Experience
(year)

Note: additional sheet of paper can be used

  1. Equipment

Equipment / Model / Responsible person / Calibration Frequency / Name of calibration laboratory

Note: additional sheet of paper can be used

  1. Reference materials

Reference materials / Lot/Batch no / Traceability / Calibration Frequency / Responsible person

Note: additional sheet of paper can be used

  1. Recordsand Archive Facilities (please specify)

…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………......

  1. Submission of documents

We enclosed herewith a copy of the following for your examination

( ) Recent organograms

( ) Master list of SOPs involved in GLP studies

( ) Master Schedule of studies

( ) List of instruments/equipments

( ) Study plans/protocols

( ) Curriculum vitae of personnel

( ) Quality documents (Quality Manual or other names, SOPs, QPs or other names,

Work Instructions, Forms. etc), please specify the title, code, revision no., issued

date, approved date, effective date.

( ) others (please specify) …………………………………………………………………...

…………………………………………………………………………………………….

  1. Diagram to show details of the testing facilities (Layout)