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6、變更程序
6.1 變更申請：變更申請部門，在“變更申請書/變更審議結(jié)果通知書”（P1/7）上的變更申請欄中注明變更目的、變更內(nèi)容等必要事項，提交變更常設(shè)機構(gòu)（QA部）受理，變更常設(shè)機構(gòu)初步確定變更的等級，然后由變更管理委員會主任審核確認。

6.2藥品管理事項及協(xié)議事項確認：變更常設(shè)機構(gòu)（QA部）就所提出的變更內(nèi)容進行初步判定，如有必要，制作“藥品管理事項確認書”（P2/7）及“協(xié)議事項確認書”（P3/7）等文件。

6.3變更管理委員會會議的舉行
6.3.1 變更管理委員會會議由變更管理委員會主任組織。
6.3.2 參加人員：品質(zhì)管理責任者、相關(guān)的驗證責任者及變更常設(shè)機構(gòu)根據(jù)變更委員會主任的指示通知的相關(guān)人員。
6.3.3 變更管理委員會基于變更申請書、變更申請部門提供的資料、藥品管理事項確認書、協(xié)議事項確認書等所提供的信息進行審議，決定變更需研究的內(nèi)容和評估項目、變更擔當部門、日程安排等事項。由變更常設(shè)機構(gòu)（QA部）填寫“變更委員會審議記錄”（P4/7）。
6.3.4變更常設(shè)機構(gòu)（QA部）在“變更申請書/變更審議結(jié)果通知書”（P1/7）的審議結(jié)果通知欄填寫委員會結(jié)論，經(jīng)變更管理委員會主任審閱后，負責聯(lián)絡(luò)事宜。另外，在本通知書上隨附藥品管理事項確認書、協(xié)議事項確認書及變更管理委員會審議記錄等相關(guān)文件。
6.3.4.1變更管理委員會審議結(jié)果認為需重新申請時，通知原申請部門重新提交變更申請書。
6.3.4.2 變更管理委員會審議結(jié)果為同意變更時，由變更常設(shè)機構(gòu)（QA部）發(fā)行變更批準書。
6.3.4.3變更管理委員會審議結(jié)果認為需進行品質(zhì)確認時，通知相關(guān)試驗擔當部門。
6.3.4.4變更管理委員會審議結(jié)果認為需實施驗證時，通知驗證組織實施變更驗證。
6.3.4.5 變更管理委員會審議結(jié)果認為需要進行變更研究時，通知變更擔當部門的責任者，由其制定“變更研究計劃書”（P5/7），經(jīng)由變更常設(shè)機構(gòu)（QA部）提交變更管理委員會主任。變更管理委員會主任確認變更研究計劃書是否合適，并報主管副總經(jīng)理審閱、生產(chǎn)管理者（QA）審批。

6.4變更研究的實施
6.4.1變更擔當部門責任者根據(jù)變更研究計劃書實施變更研究（包括實施變更驗證、品質(zhì)確認試驗或其它研究），變更研究結(jié)果記入“變更研究結(jié)果報告書/變更評估結(jié)果通知書”（P6/7），并經(jīng)變更常設(shè)機構(gòu)（QA部）提交變更管理委員會主任。

6.5變更研究結(jié)果評估
6.5.1變更管理委員會主任組織變更管理委員會會議，評估確認變更研究結(jié)果。變更常設(shè)機構(gòu)(QA部)在“變更研究結(jié)果報告書/變更評估結(jié)果通知書”（P6/7）上填寫委員會結(jié)論，通知變更擔
當部門或相關(guān)部門，并報主管副總經(jīng)理審閱、生產(chǎn)管理者（QA）審批。

6.6變更批準
6.6.1屬于等級3的變更，變更常設(shè)機構(gòu)(QA部)發(fā)行變更批準書，生產(chǎn)管理者（QA）批準后即可實施。
6.6.2屬于等級1或2的變更
6.6.2.1若無需經(jīng)國家有關(guān)機構(gòu)批準、備案或取得其他法定機構(gòu)或協(xié)議方的事先認可，且變更管理委員會審議結(jié)果認為可以變更時，變更常設(shè)機構(gòu)(QA部)發(fā)行變更批準書，由變更管理委員會主任簽署意見后交生產(chǎn)管理者（QA）批準。
6.6.2.2若需經(jīng)國家有關(guān)機構(gòu)批準、備案或取得其他法定機構(gòu)或協(xié)議方的事先認可時，由變更常設(shè)機構(gòu)（QA部）提交質(zhì)量保證部或相關(guān)部門確認，取得批準或認可后，變更常設(shè)機構(gòu)（QA部）發(fā)行變更批準書，由變更管理委員會主任簽署意見后交生產(chǎn)管理者（QA）批準。
6.6.3變更常設(shè)機構(gòu)（QA部）根據(jù)變更批準書及變更內(nèi)容通知變更擔當部門及相關(guān)部門。

6.7相關(guān)文件修訂及培訓(xùn)教育：變更擔當部門實施變更時，根據(jù)需要修訂或增加相關(guān)文件，并進行變更事項方面的教育培訓(xùn)及記錄。

6.8變更申請編號的編制方法
6.8.1變更常設(shè)機構(gòu)（QA部）負責對變更申請進行編號。變更申請編號的編制方法如下：
采用公歷日期，年份的后兩位+月份+日期—01~99（同一天申請的順序號）。
例如：2002年9月5日第三次申請變更，變更申請編號為"020905—03"

6. Procedures
6.1 Application for Change: The department applying for change will fill in the application-for-change box on the "Application for Changes/Notice on the Results of Deliberations" (P1/7) indicating the purpose of change, contents of change and other necessary items, then submit it to the Standing Organ for Changes (QA Department) for review, the Standing Organ for Changes will in turn make an initial judgment as to the degree of the change before submitting it to the Director of the Change Control Committee for verification and approval.

6.2 Identification of Items in Drug Administration and Protocol: the Standing Organ for Changes (QA Department) will make an initial judgment on the contents of the proposed change; if necessary, formulate such documents as "Verification of Drug Administration Items" (P2/7) and "Verification of Protocol Items" (P3/7).

6.3 Conventions of the Change Control Committee
6.3.1 Conventions of the Change Control Committee will be organized by the Director of the Change Control Committee.
6.3.2 Attendants: responsible persons for quality control, responsible persons for related verifications, and those related persons designated by the Standing Organ for Changes based on the instructions from the Director of the Change Control Committee.
6.3.3 The Change Control Committee will deliberate on the Application for Changes, the information provided by the department applying for change, the Verification of Drug Administration Items, and the Identification of Protocol Items, identify the contents of research on the change and the items for evaluation, identify the department responsible for the change, and arrange for schedules. The Standing Organ for the Changes (QA Department) will formulate the "Deliberation Record by the Change Control Committee".
6.3.4 The Standing Organ for Changes will fill in the deliberation-result notification section on the "Application for Changes/Notice on the Results of Deliberations" (P1/7) with conclusions by the Committee, then take on the liaising job after approved by the Director of the Change Control Committee. In addition, this notice will be attached with such related documents as the Identification of Drug Administration Items, the Verification of Protocol Items, and the Deliberation Record by the Change Control Committee, etc.
6.3.4.1 If a reapplication is considered necessary after the deliberations by the Change Control Committee, the original applicant should be notified to resubmit his application for change.
6.3.4.2 When the change is approved after the deliberations by the Change Control Committee, the Standing Organ for the Changes (QA Department) will issue the Approval for Change.
6.3.4.3 When the quality verification is considered necessary after the deliberations by the Change Control Committee, the related department responsible for test should be notified.
6.3.4.4 When the implementation of test and verification is considered necessary after the deliberations by the Change Control Committee, the test-verifying organ should be notified to carry out the tests and verifications.
6.3.4.5 When a research on the change is considered necessary after the deliberations by the Change Control Committee, the RP (Responsible Person) of the department to take on the change should be notified to formulate the "Plan for the Research on the Change" (P5/7), to be submitted to the Director of the Change Control Committee via the Standing Organ for the Changes (QA Department), and to be further submitted to the Responsible Deputy GM and Production Supervisor (QA) for approval, after being checked by the Director for its appropriateness.

6.4 Implementation of Research on Change
6.4.1 The RP of the department to take on the change will carry out the research on the change in accordance with the plan for the research on the change (including test and verifying of change, quality verification tests or other researches). The outcome of the research on the change will be written down in the "Results of the Research on the Change/Notice of Results of Evaluation on the Change" (P6/7), to be submitted to the Director of the Change Control Committee via the Standing Organ for the Changes (QA Department).

6.5 Evaluation of the Results of Research on Change
6.5.1 The Director of the Change Control Committee will organize the meetings of the Change Control Committee, evaluate and confirm the results of research into change. The Standing Organ for the Changes (QA Department) will fill in the "Results of the Research on the Change/Notice of Results of Evaluation on the Change" (P6/7) with conclusions by the Committee, notify the department to take on the change or any related department, and submit it to the Responsible Deputy GM and Production Supervisor (QA) for checking and approval.

6.6 Approval for Change
6.6.1 For the change that belongs to Degree 3, the Standing Organ for Changes (QA Department) will issue the Approval for Change, which may be implemented right after the approval by the Production Supervisor (QA).
6.6.2 Change that belong to Degree 1 or 2:
6.6.2.1 If the change requires no ratification, filing or prior approval from the State administration or other statutory entities or protocol, and if it is considered feasible after deliberations by the Change Control Committee, the Standing Organ for Changes (QA) will issue the Approval for Change, have it countersigned by the Director of the Change Control Committee, and submit it to the Production Supervisor (QA) for approval.
6.6.2.2 If the change does require ratification, filing or prior approval from the State administration or other statutory entities or protocol, the Standing Organ for the Changes (QA Department) will submit it to the QA Department or related department for confirmation; after it is ratified or approved, the Standing Organ for Changes (QA Department) will issue the Approval for Change, have it countersigned by the Director of the Change Control Committee, and submit it to the Production Supervisor (QA) for approval.
6.6.3 The Standing Organ for Changes (QA Department) will notify the department responsible for change and related department in accordance with the Approval for Change and the contents of change.

6.7 Revision of Related Documents and Training and Education: While implementing the change, the department responsible for change will revise or supplement related documents as needed, and carry out education and training on change while making notes.

6.8 Formulation of Change Application Numbers
6.8.1 The Standing Organ for Changes (QA Department) will take on the responsibility to number the application for change.
The formulating methods for numbering the application for change are as follows:
Based on solar calendar, the last two digits of the year + month + day -- 01-99 (the sequence number for the applications on the same date).
For example: the third application on September 5, 2002 will be numbered as "020905—03".