-
Change management
1
．
Basic information
, to be
completed by the change manager/change initiator
Change No.
Change initiator
Department
Initiation date
Nature of
change:
□
Permanent change
■
Temporary change
Duration:
2. Types of change
, to be
completed by the change manager
Changes in validated process
Changes in product quality
standards
Changes in key packaging materials and
labeling
Changes in key
external suppliers
Changes
in analysis method
■
Changes in unvalidated
processes
Other
Changes
Changes
in repacking
Equipment and
facilities
Signature of the change manager:
3. Change
description
, to be completed by the
change initiator
Theme
Existing condition
Proposed
condition
Reasons for change
Supporting data
, please 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)
?
Engineering
Equipment Department
(EN)
?
Safety and
Environment Protection
Department (ES)
?
Warehouse (WH)
?
Purchasing
Department
(PU)
?
HR Department (HR)
GMP impact
assessment (Annexes can be added in case of
insufficient space)
Potential quality
impact:
Y
Regulations impact:
N/A
Impact on
equipment/system validation:
N/A
Impact on
packaging/labeling:
N/A
Analysis method:
N/A
Impact of
product release:
N/A
Impact on process validation:
N/A
Impact on
cleaning validation:
N/A
Safety and environmental
impact:
N/A
Stability test:
N/A
Confidential
Other impacts:
Batch
record
Risk reduction action
plan
Change level (judged by
QA):
Critical Change
■
Major Change
Responsible
person
Due date
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:
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
Confidential