UNCONTROLLED DEVIATION REPORT

U.D.R No.            : Product Name   : Stage                 : B.No .               :

Name of the Observer : Department : Signature    :                                                                                           Date :

Deviation observed in :   1)      Mfg. Process                          [      ] 2)      Facility                                   [      ]  3)      Materials                                [      ]                 3.1)  Quality                          [      ]        3.2)  Quantity                        [      ]  4)      Vendor                                   [      ] 5)      Equipment, Instrument         [      ] 6)      Specification,  MOA             [      ]

1.0 ) Description of deviation observed (Attach additional sheet if required) :

2.0) Reasons for the deviation  :

3.0) Immediate action taken ( if any ) :

4.0) Present Status  : Executive  :                                                      Head of the dept. :            Date          :                                                      Date                      :           (Respective department)                                                                                                                                                                                        (Forward to QA)

5.0)   Investigation required / not required  :                    If investigation is required, identify the investigation team (Name of departments) :          ________________________________________          ________________________________________          ________________________________________          ________________________________________          ________________________________________          ________________________________________          QA Signature     :                                                                            Date    :

6.0)  Investigation report :       7.0)   Corrective action proposed:

8.0 ) Preventive action :                                                                                                                                                  Signature of investigation team : Name                                               Dept.                                Signature                      Date ____________________         __________________             ________________         __________ ____________________         __________________             ________________         __________ ____________________         __________________             ________________         __________ ____________________         __________________             ________________         __________

9.0 )   Signature of Head of the Departments  :            9.1)    Production           Approved /Not Approved    ________________    ___________                                 9.2)    QCD                    Approved /Not Approved    ________________    ___________            9.3)    PD                       Approved /Not Approved    ________________    ___________                             9.4)    Engg.                   Approved /Not Approved    ________________    ___________                                    9.5)    Ware House        Approved /Not Approved    ________________    ___________           9.6)   Safety and Envi.  Approved /Not Approved     ________________   ___________ 9.7)   Plant Incharge     Approved /Not Approved    ________________    ___________                  9.8)    QA                      Approved /Not Approved     ________________   ___________

10.0)   Stability to be kept :     Yes                 [        ]           No.        [        ]             If Yes, specify the type of stability study :

Results after action is taken: QA Signature :                                                                                      Date               :