PHASE II INVESTIGATION REPORT FOR OSS

                                                                                                                          OOS No.         :

Date                :

 Name of Finished Product/Raw material/Intermediate/ Stability Samples:

 Lot / Batch No. / A.R. No.                                                      :

 Specification No.                                                                     :

 Test Procedure No.                                                                  :

 Test OOS result is found                                                         :

 Result                                                                                      :

Conclusion of Phase 1 Investigation                                      :

Phase II Investigation Started on                                           :

1. Evaluation of sampling procedure                                      :

2. Evaluation of manufacturing process                                 :

3. Evaluation of Records                                                        :

 3.1 Manufacturing Records                                                :

3.2 Other related records                                                     :

4. Evaluation of other related batches                                    :

             (if likely to have impact)

i) Final Status of the batch                                                      :

ii) Cause of OOS found

Investigation Report Reviewed By:

                                                     Production Manager            :                                               Date:

                                                     QA Manager                        :                                               Date:

                                                     Q.C. Manager                      :                                               Date:

Investigation Report Approved By:

                                                     QA Head                             :                                               Date:

iii) Corrective measures Recommended                                 :

RETEST ANALYSIS

Product                                     :                                               A.R. No.         :

Test OOS it found        :

RETEST RESULTS

S. No.	Test Name	Result	Analyst	Date
Conclusion:

                                                           RESAMPLE  (RETESTING)

Product  Name                        :                                               A.R. No.              :

Sampled By                :                                               Date of Sampled  :

Test OOS it found      :                                  

                                                                       RESAMPLE RESULTS

S. No.	Test Name	Result	Analyst	Date
Conclusion :

Checked By    :           ____________________________                            Date    :           ______________

                                                (QC Manager)