KU PHARMACEUTICALS PRIVATE LIMITED

PROCESS VALIDATION PROTOCOL [ Page No: 1 of 9]

Validation Protocol No.: ___________________________________

Name of the Products :

Protocol written by ____________________________________________ Date _____________________

Approval ____________________________________________________Date _____________________

Approval ____________________________________________________ Date _____________________

Approval _____________________________________________________Date _____________________

___________________________________________________________________________________________

Objective:

To determine that process consistently performs as intended by repeatedly running the system on its intended
schedules and recording all relevant information and data. Results must demonstrate that the process meets pre-
determined specifications under normal conditions, and where appropriate worst case conditions.
___________________________________________________________________________________________
Scope:
To be performed with validated equipment in the specified location in validated premises. If equipment or systems
or the facility are modified or the premises where the process takes place is changed, or the process is relocated,
the process must be re-validated after the systems, equipment and facility qualifications, as appropriate, have
been performed and approved.
___________________________________________________________________________________________
Responsibility:

The persons responsible for the process will perform the validation and record the information. The responsible
person will supervise the study, verify the completion of the records and write the report. Quality Assurance will
review and approve the Process Validation Protocol and Report.
Name of the Personnel Designation Signature

………………………….. …………………………………….. …………………………

………………………….. …………………………………….. …………………………
………………………….. …………………………………….. …………………………
………………………….. …………………………………….. …………………………

2/2/2010 10:32:44 AM ASSIGNMENT ON PROCESS VALIDATION/ FORMATS/BIBEK SINGH MAHAT

 KU PHARMACEUTICALS PRIVATE LIMITED
PROCESS VALIDATION PROTOCOL [ Page No: 2 of 9]

Materials, Equipments and Documents:

Master Formulation Record (MFR), Batch Manufacturing Record, Equipment List with Equipment No. and all the
Standard Operating Procedures (SOPs) for normal operation of the processes under test.

Documents of Normal Operation:

Name of the Document Document No. Effective Date
Master Formulation Record

Batch Manufacturing Record

List of Equipments
Name of Equipment Equipment No.: Qualification Completed
DQ IQ OQ PQ

Compiled by: ____________________________________________________________ Date: ____________

Reviewed by: ____________________________________________________________ Date: ____________

2/2/2010 10:32:44 AM ASSIGNMENT ON PROCESS VALIDATION/ FORMATS/BIBEK SINGH MAHAT

 KU PHARMACEUTICALS PRIVATE LIMITED
PROCESS VALIDATION PROTOCOL [ Page No: 3 of 9]

Procedure:-

Performance:-
1. Process: Run full process according to SOP three times and record all required data.
2. Deviations to the procedures must be recorded on the data record forms.
3. Analytical tests: Perform the routine tests associated with the process according to the SOP
4. Test results must be approved by QC.

Evaluation :-
1. Attach all data record forms and charts.
2. Perform all necessary calculations and statistical analyses (pre-determined).
3. Compare to acceptance criteria.
4. Prepare Deviation Report (including the justification of acceptance and impact on the process).

Prepare a Process Validation Report:-

This should include for each validation run:
1. Date study initiated; date completed; observations made;
2. Problems encountered; completeness of information collected; summary of the deviation report;
3. Results of tests and statistical analyses; do results meet acceptance criteria; location of original data;
4. Other information relevant to the study.

Conclusions will be made on the validity of the process in individual runs and on the three
Consecutive Validation Runs.

Approval

1. Submit the Document to QA for review and approval.

2. The Process must meet all specifications for three consecutive runs.

Compiled by: ____________________________________________________________ Date: ____________

Reviewed by: ____________________________________________________________ Date: _____________

2/2/2010 10:32:44 AM ASSIGNMENT ON PROCESS VALIDATION/ FORMATS/BIBEK SINGH MAHAT

 KU PHARMACEUTICALS PRIVATE LIMITED
PROCESS VALIDATION PROTOCOL [ Page No: 4 of 9]

Processing Parameters of Production

S.N. Processing Step Control Points Test Points Acceptance Criteria

Compiled by: ____________________________________________________________ Date: _____________

Reviewed by: ____________________________________________________________ Date: _____________

2/2/2010 10:32:44 AM ASSIGNMENT ON PROCESS VALIDATION/ FORMATS/BIBEK SINGH MAHAT

 KU PHARMACEUTICALS PRIVATE LIMITED
PROCESS VALIDATION PROTOCOL [ Page No: 5 of 9]

List of attached Data Record Forms:-

Compiled by: ____________________________________________________________ Date: ___________

Reviewed by: ____________________________________________________________ Date:_____________

2/2/2010 10:32:44 AM ASSIGNMENT ON PROCESS VALIDATION/ FORMATS/BIBEK SINGH MAHAT

 KU PHARMACEUTICALS PRIVATE LIMITED
PROCESS VALIDATION PROTOCOL [ Page No: 6 of 9]

Calculation and Statistical Analysis

Compiled by: ____________________________________________________________ Date: __________

Reviewed by: ____________________________________________________________ Date: __________

2/2/2010 10:32:44 AM ASSIGNMENT ON PROCESS VALIDATION/ FORMATS/BIBEK SINGH MAHAT

 KU PHARMACEUTICALS PRIVATE LIMITED
PROCESS VALIDATION PROTOCOL [ Page No: 7 of 9]

Acceptance Criteria Vs Test Results

Parameter Specification Result Pass/Fail

Compiled by: ____________________________________________________________ Date: __________

Reviewed by: ____________________________________________________________ Date: ___________

2/2/2010 10:32:44 AM ASSIGNMENT ON PROCESS VALIDATION/ FORMATS/BIBEK SINGH MAHAT

 KU PHARMACEUTICALS PRIVATE LIMITED
PROCESS VALIDATION PROTOCOL [ Page No: 8 of 9]

Deviations:

Justification for Acceptance:

Impact on Process:

Written by: _______________________________________________________________ Date: __________

Reviewed by: ____________________________________________________________ Date: ___________

2/2/2010 10:32:44 AM ASSIGNMENT ON PROCESS VALIDATION/ FORMATS/BIBEK SINGH MAHAT

 KU PHARMACEUTICALS PRIVATE LIMITED
PROCESS VALIDATION PROTOCOL [ Page No: 9 of 9]

Process Validation Report :-

Results:-

Conclusion:-

Written by: _______________________________________________________________ Date: ____________

Reviewed by: ____________________________________________________________ Date: ___________

2/2/2010 10:32:44 AM ASSIGNMENT ON PROCESS VALIDATION/ FORMATS/BIBEK SINGH MAHAT