leadon1． Basic information, to be completed by the change manager/change initiator | ||||||||||||||||||
Change No. | Department | |||||||||||||||||
Change initiator | Initiation date | |||||||||||||||||
Nature of change:□Permanent change ■ Temporary change Duration: | ||||||||||||||||||
月亮的起源2. Types of change, to be completed by the change manager | ||||||||||||||||||
Changes in validated process Changes in product quality standards Changes in repacking Changes in key packaging materials and labeling Equipment and facilities Changes in key external suppliers Changes in analysis method ■Changes in unvalidated process Other Changes Signature of the change manager: | ||||||||||||||||||
3. Change description, to be completed by the change initiator | ||||||||||||||||||
Theme | ||||||||||||||||||
Existing condition | ||||||||||||||||||
Propod condition | ||||||||||||||||||
Reasons for change | ||||||||||||||||||
Supporting data, plea list additional or reference document if necessary. | ||||||||||||||||||
4. Impacted department, to be completed by the change initiator and QA jointly | ||||||||||||||||||
■ Quality Assurance (QA) | ■ Quality Control (QC) | ■ Production Department (PR) | norman rockwell Engineering Equipment Department (EN) | |||||||||||||||
Warehou (WH) | Purchasing Department (PU) | HR Department (HR) | Safety and Environment Protection Department (ES) | |||||||||||||||
GMP impact asssment (Annexes can be added in ca of insufficient space) | ||||||||||||||||||
Potential quality impact: Y | Impact of product relea: step up 4N/A | |||||||||||||||||
Regulations impact: N/A 备考注意事项 | Impact on process validation: N/A | |||||||||||||||||
Impact on equipment/system validation: N/A | branchImpact on cleaning validation: N/A | |||||||||||||||||
Impact on packaging/labeling: N/A | Safety and environmental impact:N/A | |||||||||||||||||
Analysis method: mba班培训N/A | Stability test: N/A | |||||||||||||||||
Other impacts: Batch record | ||||||||||||||||||
Risk reduction action plan | Responsible person | Due date | ||||||||||||||||
Change level (judged by QA): Critical Change ■Major Change Minor Change Signature of the QA/date: Shen Jie/ April 22, 2020 | ||||||||||||||||||
5. Pre-approval of change application, to be completed by the change pre-approver | ||||||||||||||||||
Review department | Review opinions | Signature | Date | |||||||||||||||
Is it necessary to notify the customer: Yes□ No■ Is it necessary to notify the authority: Yes□ No■ Verifier/date: | ||||||||||||||||||
新东方官网Comments from the customer or the authority: Verifier/date: | ||||||||||||||||||
Approver from QA/date: | ||||||||||||||||||
6. Completion of risk reduction actions, to be completed by the change manager | ||||||||||||||||||
Action No. | Completion date | Action No. | Completion date | |||||||||||||||
Verifier/date: Shen Jie/ April 25, 2020 | ||||||||||||||||||
7. Approval of change, to be completed by the change approver | ||||||||||||||||||
Final approval department of change | Final approval opinions | Signature | Date | |||||||||||||||
Conclusion: Approver/date: | ||||||||||||||||||
8. Change implementation date, to be completed by the head of the department to implement the change | ||||||||||||||||||
Implementation date: | Signature of the head of the department to implement the change/date: | |||||||||||||||||
9. Evaluation of change implementation effect, to be completed by the change manager | ||||||||||||||||||
Implementation effect: Signature of QA verifier/date: | ||||||||||||||||||
10. Change closure, to be completed by the QA Manager | ||||||||||||||||||
■The change achieves the expected effect and has no influence on other systems □Change canceled. Plea state the reason: N/Abeen是什么意思 Pre-change status restoration date: N/A | ||||||||||||||||||
Change closure date: | Signature of the QA Manager/date: | |||||||||||||||||
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