Biomedical Engineering Reference
In-Depth Information
Key performance indicator:
GMP, GLP, & SOP DEVIATION (ICRs)
Report for the month of
Total number of ICRs:
Deviation from
GMP & SOP
1
Total
No.
5
Root
Cause
6
Corrective
Action
7
Preventive
Action
8
Minor
2
Major
3
Critical
4
Stores
Production
Quality control
Packaging
Maintenance
Information provided by:
Name and signature:
Date:
Note:
1. The corresponding areas have already been given in this column for which the deviation is
to be recorded.
2. If the deviation is minor.
3. If the deviation is major.
4. If the incident is critical.
5. Total number of deviations in the corresponding area.
6. Root cause determined.
7. What corrective action was taken, if any.
8. What preventive measures were recommended, if any.
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