优良室操作国家符合性监控系统

1、財團法人全國認證基金會 TAF-GLP-B01(4)Taiwan Accreditation Foundation優良實驗室操作國家符合性監控系統申請書Good Laboratory Practice (GLP)National Compliance Monitoring Program Application Form(適用於初次符合性登錄申請、延展符合性登錄申請與增類符合性登錄申請)(For initial compliance registration applications, renewal compliance registration applications, and expa

2、nding-the-expertise application)親愛的申請人 您好！在 您向財團法人全國認證基金會（以下稱基金會）提出優良實驗室操作符合性監控申請之前，請 您務先詳閱本申請書及相關附件。當 您填妥以下表格並提出申請後，所有條款均將構成雙方權利義務規範之一部份。Dear Applicant, Greetings! Before tendering your application for the Good Laboratory Practice (GLP) Compliance Monitoring Program (a program established under the

3、 directive of the MOEA Bureau of Standards, Metrology, and Inspection) to the Taiwan Accreditation Foundation (hereafter referred as TAF), please carefully read the provisions stated in the application form and all pertaining attachments. Once the following forms are completed and submitted to the T

4、AF, all the conditions therein stated shall immediately constitute a written agreement of rights and obligations between you and the TAF.本欄申請機構請勿填寫 This column is to be filled by the Department of Laboratory Accreditation試驗單位申請編號： 試驗單位登錄編號：Applicant Number of Test Facility: Registered Number of Test

5、 Facility:： 收 文 編 號：Date accepted: Document No.: 承辦人Processing personnel:申請審查與聯絡紀錄 Application assessment and communication record:財團法人全國認證基金會Taiwan Accreditation Foundation本人（機構負責人姓名）代表I, (full name of the Person in-charge of applicant body) on behalf ofFull Name ofOrganization/Company機構全名（中文）(Chin

6、ese)（英文）(English)機構地址Business Address郵遞區號：Postal Code:（中文）(Chinese)（英文）(English)向財團法人全國認證基金會提出試驗單位 GLP符合性登錄申請，並同意接受貴會之符合性登錄之權利義務規章hereby submits a Test Facility GLP compliance registration application to the Taiwan Accreditation Foundation, and agrees to abide by the TAF Articles of Rights and Oblig

7、ations for compliance registration.申請類別為(請於適當方框內勾選) 初次符合性登錄申請延展符合性登錄申請增類符合性登錄申請Type of application: (Please tick the appropriate box) Initial compliance registration application Renewal compliance registration application Expanding-the-expertise application本機構申請試驗單位的編號:_(若已是符合性登錄試驗單位請填寫)Code of the

8、Applicant Test Facility of Organization: _ (Please fill out this column if already a registered compliant test facility.)Full name ofTest Facility試驗單位名稱（中文）(Chinese)（英文）(English)試驗單位地址Address of Test Facility 郵遞區號：Postal Code:（中文）(Chinese)（英文）(English)本機構指定（中文姓名）為GLP試驗單位管理階層代表，負責監督本試驗單位遵守 貴會所訂相關規章。本

9、機構授權GLP試驗單位管理階層代表本機構就本申請案與 貴會進行查核相關事宜。We have hereby designated _ (name) as the official GLP management representative of the test facility and empowered him/her responsible for supervising test facility operations to ensure the compliance of the test facility to the related TAF regulations. We have

10、 authorized the official GLP management representative of the test facility to process the inspection related matters regarding this application with the TAF on our behalf.申請機構印鑑 機構負責人簽章Official Seal of the Applicant Organization Signature of the Person in-Charge申請日期：年月日Date of Application: _ (month

11、 / day / year)附件AttachmentOECD優良實驗室操作（GLP）國家符合性監控系統符合性登錄之權利義務規章The Good Laboratory Practice (GLP) National Compliance Monitoring Program Articles of Rights and Obligations for Compliance Registration1. 貴機構試驗單位管理階層發佈適用範圍聲明，說明其研究乃符合GLP規範實施，並遵守相關法律或有關GLP之行政程序規定。The management of your test facility shou

12、ld issue a statement on the range of your compliance registration. The statement should state that study was conducted pursuant to GLP criteria and complies with related governing laws or related GLP administrative procedures and regulations. 2. 貴機構試驗單位符合OECD GLP規範，並獲得本會GLP國家符合性監控系統之符合性登錄，研究主持人即可於研究

13、計畫報告中宣告該研究符合GLP規範之符合性聲明。應於提供給報告收受之權責單位，在產品註冊申請時，所附之研究報告上顯示此符合性登錄之聲明。研究主持人之符合性聲明必須純為事實宣告，不得有任何誤導之情事。 The test facility of the applicant facility should comply with the OECD GLP Principles, and achieve compliance registration under GLP Compliance Monitoring Program of the TAF. The Study Director may s

14、tate in the study report that study conducted is compliant with GLP criteria. He/she should also furnish the authorities receiving the report the attached study report stating this compliance registration during the product registration application. The compliance registration declaration of the Stu

15、dy Director should be a mere statement of the fact and should not, in anyway, may be a reason to mislead. 3. 符合性登錄機構必須具備符合OECD優良實驗室操作規範、本會相關規範，且必須依據書面規範運作。 The compliance registration test facility should be equipped with the OECD Good Laboratory Practice criteria and related TAF regulations. Moreov

16、er, all operations should be implemented pursuant to the documented criteria. 4. 符合性登錄機構必須允許查核小組進入 貴機構之相關作業場所、設施，並取得所需資源、作業、程序、紀錄，以及約談必要人員，使本會能有效的針對 貴機構GLP系統及活動進行查核。 The compliance registration test facility should permit the entry of the inpection team into the related place of work and equipment o

17、f the test facility, and provide the inspection team with the needed resources, operation information, procedures, and records, as well as opportunity to interview related personnel of a study This will enable TAF to conduct an effective monitoring of the GLP program and activities. 5. 取得符合性登錄時，本會將發

18、予貴機構登錄證明，同時將貴機構已獲得登錄及登錄範圍細節本會網站。Upon the approbation of your compliance registration, the TAF shall issue a compliance registration attestation to your organization, and at the same time post details of your compliance registration and scope of your registration on the TAF website.6. 符合性登錄機構可使用符合性登錄

19、標誌於研究計畫之報告封面。其使用之規定為使用符合性登錄標誌與宣稱符合性要求（TAF-GLP-R02）。The compliance registration test facility may stamp the compliance registration logo on the cover page of the study report. Logo usage regulations require the usage of the compliance registration logo together with a declaration stating compliance t

20、o TAF requirements (TAF-GLP-R02). 7. 如符合性登錄標準有所變更，本會將立即通知 貴機構並給予合理的時間，俾使 貴機構能調整程序以達到新規定的要求。 In the event of changes in the compliance registration standards, the TAF shall immediately notify your organization of such information and provide you with a rational period to implement amendments in your

21、procedures, thus enabling you to maintain your compliance to the new regulatory requirements. 8. 當試驗單位發生嚴重偏離事項或政府不再委託本會執行此符合性監控系統時，將終止此規章之相關事項。When a test facility commits a serious deviation or if the government withdraws the TAF authorization for implementing the compliance monitoring program, all

22、 matters established under such provisions shall likewise expire.9. 當發生爭議、糾紛、歧見或違反時，依政府相關法律程序處理。In the event of disagreements, disputes, differences in interpretation, or violations to the foregoing provisions, the legal procedures provided in the governing R.O.C. laws shall apply. 試驗單位符合性登錄申請應檢附的資料

23、：(請勾選所檢附的資料)Supporting documents for attachment to the Test Facility Compliance Registration Application Form: (Please tick box of attached documents)為能順利處理申請案，請於寄出前務必確認以下申請資料的齊備與完整For the smooth and easy processing of your application, please make sure the following supporting documents are attache

24、d to your application before mailing or submitting application form: 1. 申請書兩份（正本乙份，影本乙份）Two copies of the application form (original and photocopy, 1 each) 2. 機構法定證件（證件名稱）影本乙份 （如公司執照，法人登記證）Legal documents of the organization (name of document), one photocopy (e.g., company license, corporation registration certificate) 註1: 初次符合申請者務必檢附機構法定證件，延展/增類申請者可免。Note 1: Initial compliance registration applicants are required to attach the legal documents of the organization. This requirement is not applicable to applicants applying for renewal or expanding the experties. 3. 請所