Sterile Formulation Investigation Report

i.            EVENT TYPE / DETAILS

a.       Investigation Report No.

b.      Investigation Type

i.       Interim Report

ii.      Final Report

c.       Type of Event

d.      Event Reference No.

e.       Product/Material Name

f.       Batch/A.R. Number

 

ii.            EVENT DESCRIPTION

iii.            EVENT CLASSIFICATION

a.       Critical

b.      Major

c.       Minor

iv.            REMEDIAL ACTIONS

v.            INVESTIGATION

a.       Data collection

b.      Root Cause Analysis (Hypothesis and identification of Probable Root Cause)

c.       Impact Analysis

d.      Conclusion

vi.            CAPA

a.       Proposed Corrective and Preventive Actions

b.       Responsibility

c.       CAPA Reference No.

d.       Target Completion Date