DOC No.

: Z/F/06/30A
REVITAL HEALTHCARE (EPZ) LTD ISSUE DATE : 01/09/2019
VALIDATION REPORT REV. No. : 00

Operational Qualification Report

For
Syringe Assembling Machine
Machine Identification Name: ____________
Report No: ________________

Revital Healthcare (EPZ) LTD Signature Date

Prepared by: 29/04/2020
Pramod Kumar
Reviewed by: 29/04/2020
Kevin Mochama
Reviewed by: 29/04/2020
Nancy Mwangi
Reviewed by: 29/04/2020
Lucy Caster
Approved by: 29/04/2020
Ankur Vora

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 DOC No. : Z/F/06/30A
REVITAL HEALTHCARE (EPZ) LTD ISSUE DATE : 01/09/2019
VALIDATION REPORT REV. No. : 00

1. Purpose
The purpose of this report is to define the operating range for the following syringe
Assembling Machine after performing series of experiments as defined in the OQ
protocol.

2. Conclusion
Operation qualification validation is “PASS.”
2.1 Operation condition
From the result of experiment and Challenge Condition, standard operation condition
shall be as follows.

MACHINE RUNNING SPEED R.P.M of the motor

5 880
6 1056
7 1232
8 1408
9 1584

2.2 Challenge test

As indicated in the (Attachment 2), all the evaluations are PASS and the operation
conditions are confirmed as appropriate.
3. Applied protocol
Protocol number: _____________
4. Conducting department
The production department has prepared the protocol. QA Department has assisted in
execution and review & Approval of the document. QA with manufacturing has tested
the material/ product as defined in the protocol.

5. Functions of adjustment and performance result

The tests performed are the Visual inspection (physical), and performance test for
experimental and challenge tests which are sufficient to determine the quality of the
product.

6. Result of the experiment

All the results obtained during validation as per the protocol were evaluated and found
satisfactory. The conditions which are more favorable for the machine and product was
evaluated and the set/ standard condition is defined accordingly.

7. Conclusion
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 DOC No. : Z/F/06/30A
REVITAL HEALTHCARE (EPZ) LTD ISSUE DATE : 01/09/2019
VALIDATION REPORT REV. No. : 00

The above table indicates the mixing duration of the raw material. In routine the machine
would run at Standard duration and its range would be monitored. At no point the
machine would be allowed to deviate from its suitable operating duration.
All the supporting documentation like SOPs, Equipment Calibration Log and all other
schedule etc. pertaining to the machine/ process/ product etc. are identified and reviewed
wherever required and kept ready for further execution.
Refer attachments as follows
Sr. No. Document Title
1. Attachment 1. Visual and performance rest report(Experimental condition)
2. Attachment 2 Visual and performance rest report(Challenge test)

8. Remark
There are no unexpected results or Deviations observed during execution of the OQ
protocol. All the trial samples generated in the study will be destroyed as per internal
disposal procedure.

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