Change Control Number: ____________________________
Requester to Complete
1. Requester Information
Name of Requester
|
|
||
Department
|
|
Contact
|
|
Urgency of change
|
|
Date
|
|
2. Change information
Action
|
|
Document to be changed (if known)
|
|
Document number to be changed
(if known) i.e. SS-XXXX-00A
|
|
Raw material code
or Finished Product
code and description
|
Code:
|
Description:
|
|
Other related information
i.e. DR; Audit
|
|
3. Details of Change
Reason for Change
|
|
Current value/text
|
|
|
Proposed value/text
Technical Service
to Complete
Type of Change
|
|
Documents affected (including Technical
Document, SOPs, Artworks)
|
|
Other Codes affected
|
|
Update required in database
|
|
Technical Service Manager
to Complete
Technical Service Manager
Approval for
Change to go Ahead
|
Yes
|
Yes with additional approval
|
|
Sign
|
Date
|
Other to Complete
(If required)
Laboratory Manager
(or delegate)
|
Name
|
|
Sign
|
Date
|
|
Comment
|
QA Manager
(or delegate)
|
Name
|
|
Sign
|
Date
|
|
Comment
|
||
Regulatory Manager
(or delegate)
|
Name
|
|
Sign
|
Date
|
|
Comment
|
||
Associated Supply
Manager
(or delegate)
|
Name
|
|
Sign
|
Date
|
|
Comment
|
Technical Service
Coordinator
Name:
Change Completion
Coordinator
|
Name
|
|
Sign
|
Date
|
|
Approval for change
completed
|
Name
|
|
Sign
|
Date
|
|
Comment
|
No comments:
Post a Comment