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TABLE OF CONTENT

1. Objective

2. Scope3. Responsibility

4. Procedure5. List of measuring devices in the instrument requiring calibration

6. List of standard apparatus and instruments required for performing calibration7. Calibration Record

8. List of attachments9. List of documents (SOPs/manual)

10. List of operators trained11. Acceptance Criteria For Operational Test

a. Test in normal conditionb. Test of worst case situation

12. Deviation Report13. Operational Qualification Report

Appendices

Performed by__________________________________________________ Date ____________________

Verified by ____________________________________________________ Date ____________________

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Name of equipment: B.O.D. Incubator Serial no.:

Equipment Identification no.: - Model No.:Manufacturer (Name & address)

Manufactured by ..

Purchase order No.:____________________________________________

Validation protocol no: _________________________________________

Location: Quality Control Department, Microbiology Testing Room

_____________________________________________________________________________________________

Protocol written by: .. Date _______________

Approval: ) Date _______________

.) Date _______________

..) Date _______________

.) Date _______________

. ) Date _______________

.) Date _______________

1. Objective: To determine that B.O. D. low temperature incubator, model no..) operatesaccording to its requirement, and to record all relevant information and data to demonstrate it functions as

expected_____________________________________________________________________________________________

2. Scope: To be performed at time of operation, modification or relocation as per SOP.

_____________________________________________________________________________________________

3. Responsibility:

1. Approving body as listed above will be responsible for approving the protocol prior to the beginning of the

qualification work.2. Qualification performers: Officers from the Engineering Department, Production Department where the

instrument is installed and QA Department. QA Assistant Officers can also be involved during machine

qualification.3. Qualification performers will observe the operation of instrument and collect and verify the test results.4. One of the qualification performers will initial in performed by and HOD QA shall initial in verified by.

5. Validation Manager will approve the OQ report.

Performed by__________________________________________________ Date ____________________

Verified by ____________________________________________________ Date ____________________

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4. Procedure:

1. Prepare a checklist for instrument functional test, its functional specification and critical operating

parameters.

2. Prepare and approve SOPs for operation and cleaning of the instrument.

3. Provide training to the operators for the systems ofinstrument and record it.

4. Have OQ protocol approved by the approving body.

5. Test and Record the calibration data for calibrating apparatus and instruments.

6. Measure and record the results of specific challenge to the instruments in worst condition where

appropriate.

7. Record any deviations to the instrument, its operation.

8. Prepare a Deviation Report including the justification of acceptance and impact on the function.

9. Prepare an OQ Report: This should include date of study initiated; completed; observations made;

problems encountered; completeness of information collected; summary of deviation report; results of

tests, location of original data other relevant information; and conclusions on the validity of the

installation.

10. Submit the report for review and approval.

Performed by__________________________________________________ Date ____________________

Verified by ____________________________________________________ Date ____________________

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5. List of measuring devices in the instrument requiring calibration.

Name of the monitoring devices

1. Programmable Digital Temperature Controller

2.

3.

4.

5.

6. List of standard apparatus and instruments required for performing calibration:

Name of the Apparatus/instruments Code no: Calibration validity

1. Digital Multi meter -

2. Ammeter -

3. Calibrated Thermometers -

4. Spirit Level -

5. -

7. Calibration Record

Name of the measuring devices Calibrated date Calibration methodAcceptable

Value/RangeObservation

(A/N)

Digital Multi meter NA Acceptable

Calibrated Thermometer(-0 to 360)oC Acceptable

Calibrated Thermometer(0 to 300)oC Acceptable

Note: A- Acceptable and N- Not acceptable

Deviations if any:_______________________________________________________________________________

_____________________________________________________________________________________________

Performed by__________________________________________________ Date ____________________

Verified by ____________________________________________________ Date ____________________

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8. List of attachments

Operating Instruction & Warrantee Card

_____________________________________________________

_____________________________________________________

9. List of documents (SOPs and/ or manual required for operation)

QC Sop no of B.O.D Incubator

10. List of operators trained

S. No. Name Sign Date

Deviations if any:_______________________________________________________________________________

_____________________________________________________________________________________________

Performed by__________________________________________________ Date ____________________

Verified by ____________________________________________________ Date ____________________

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11. Acceptance Criteria For Operational Test

a. Test in normal condition (if applicable):

S.NO. Operating CriteriaAcceptance

CriteriaPass/Fail Sign Date

1. Electrical Connection

2.

Switch on the main toggle at Switch ON position.

Rotate main heat switch knob.

3. Switch OFF the main toggle at off position

4. Press push button of PLC controller.

5.

Switch ON the mains and load the tray with materials at a

gap of 3 to 4 cm between two articles and the incubatorwall.

Set the temperature (SV) and record the temperature shownin (PV) display.

6. Fluorescence lamp

Deviations if any:______________________________________________________________________________

_____________________________________________________________________________________________

Performed by__________________________________________________ Date ____________________

Verified by ___________________________________________________ Date ____________________

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b. Test of worst case situation (if applicable):

Tests ResultsStatus

Pass/FailSign Date

_________________________________________________________________________________________________

Deviations:____________________________________________________________________________________

_____________________________________________________________________________________________

_____________________________________________________________________________________________

Performed by: ______________________________________________________ Date :____________________

Verified by:________________________________________________________ Date: ____________________

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12. Deviation Report

Report written by: _____________________________________________________ Date ___________________

Verified by: __________________________________________________________ Date ___________________

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13. Operation Qualification Report

Report Written by: __________________ QA, Asst. Officer Date:_____________________

Report Reviewed by: ___________________ HOD QA Date:_____________________

___________________ HOD Engineering Date:_____________________

___________________ HOD QC Date:_____________________

___________________ PMD Manager Date:_____________________

___________________ QMD Manager Date:_____________________

Report Approved by: __________________ VP-Technical Affairs Date:_____________________

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APPENDICES