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6、变更程序
6.1 变更申请:变更申请部门,在“变更申请书/变更审议结果通知书”(P1/7)上的变更申请栏中注明变更目的、变更内容等必要事项,提交变更常设机构(QA部)受理,变更常设机构初步确定变更的等级,然后由变更管理委员会主任审核确认。

6.2药品管理事项及协议事项确认:变更常设机构(QA部)就所提出的变更内容进行初步判定,如有必要,制作“药品管理事项确认书”(P2/7)及“协议事项确认书”(P3/7)等文件。

6.3变更管理委员会会议的举行
6.3.1 变更管理委员会会议由变更管理委员会主任组织。
6.3.2 参加人员:品质管理责任者、相关的验证责任者及变更常设机构根据变更委员会主任的指示通知的相关人员。
6.3.3 变更管理委员会基于变更申请书、变更申请部门提供的资料、药品管理事项确认书、协议事项确认书等所提供的信息进行审议,决定变更需研究的内容和评估项目、变更担当部门、日程安排等事项。由变更常设机构(QA部)填写“变更委员会审议记录”(P4/7)。
6.3.4变更常设机构(QA部)在“变更申请书/变更审议结果通知书”(P1/7)的审议结果通知栏填写委员会结论,经变更管理委员会主任审阅后,负责联络事宜。另外,在本通知书上随附药品管理事项确认书、协议事项确认书及变更管理委员会审议记录等相关文件。
6.3.4.1变更管理委员会审议结果认为需重新申请时,通知原申请部门重新提交变更申请书。
6.3.4.2 变更管理委员会审议结果为同意变更时,由变更常设机构(QA部)发行变更批准书。
6.3.4.3变更管理委员会审议结果认为需进行品质确认时,通知相关试验担当部门。
6.3.4.4变更管理委员会审议结果认为需实施验证时,通知验证组织实施变更验证。
6.3.4.5 变更管理委员会审议结果认为需要进行变更研究时,通知变更担当部门的责任者,由其制定“变更研究计划书”(P5/7),经由变更常设机构(QA部)提交变更管理委员会主任。变更管理委员会主任确认变更研究计划书是否合适,并报主管副总经理审阅、生产管理者(QA)审批。

6.4变更研究的实施
6.4.1变更担当部门责任者根据变更研究计划书实施变更研究(包括实施变更验证、品质确认试验或其它研究),变更研究结果记入“变更研究结果报告书/变更评估结果通知书”(P6/7),并经变更常设机构(QA部)提交变更管理委员会主任。

6.5变更研究结果评估
6.5.1变更管理委员会主任组织变更管理委员会会议,评估确认变更研究结果。变更常设机构(QA部)在“变更研究结果报告书/变更评估结果通知书”(P6/7)上填写委员会结论,通知变更担
当部门或相关部门,并报主管副总经理审阅、生产管理者(QA)审批。

6.6变更批准
6.6.1属于等级3的变更,变更常设机构(QA部)发行变更批准书,生产管理者(QA)批准后即可实施。
6.6.2属于等级1或2的变更
6.6.2.1若无需经国家有关机构批准、备案或取得其他法定机构或协议方的事先认可,且变更管理委员会审议结果认为可以变更时,变更常设机构(QA部)发行变更批准书,由变更管理委员会主任签署意见后交生产管理者(QA)批准。
6.6.2.2若需经国家有关机构批准、备案或取得其他法定机构或协议方的事先认可时,由变更常设机构(QA部)提交质量保证部或相关部门确认,取得批准或认可后,变更常设机构(QA部)发行变更批准书,由变更管理委员会主任签署意见后交生产管理者(QA)批准。
6.6.3变更常设机构(QA部)根据变更批准书及变更内容通知变更担当部门及相关部门。

6.7相关文件修订及培训教育:变更担当部门实施变更时,根据需要修订或增加相关文件,并进行变更事项方面的教育培训及记录。

6.8变更申请编号的编制方法
6.8.1变更常设机构(QA部)负责对变更申请进行编号。变更申请编号的编制方法如下:
采用公历日期,年份的后两位+月份+日期—01~99(同一天申请的顺序号)。
例如:2002年9月5日第三次申请变更,变更申请编号为"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".




 
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