FORMEL LABS PRIVATE LIMITED

DEPARTMENT- PRODUCTION

OPERATIONAL QUALIFICATION PROTOCOL

Equipment. TRAY DRYER Effective Date

Protocol No. FL1/OQ/P/MM-001/001-00

OPERATIONAL QUALIFICATION PROTOCOL

FOR THE

MULTIMILL

A/PD/MM-001

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 FORMEL LABS PRIVATE LIMITED

DEPARTMENT- PRODUCTION

OPERATIONAL QUALIFICATION PROTOCOL

Equipment. TRAY DRYER Effective Date

Protocol No. FL1/OQ/P/MM-001/001-00

Table of Content
SR. NO. DESCRIPTION Page No.

-- Cover page 1

-- Table of contents 2

-- Protocol approval page 3

1.0 Purpose 4

2.0 Scope 4

3.0 Responsibility 4

4.0 Equipment Name 5

5.0 Equipment Code 5

6.0 Equipment / System Description 5

7.0 Operating conditions 6

8.0 Attachments 6

9.0 Test for operational qualification 6-19

10.0 Deviation report 20

11.0 Summary and Conclusion 21

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 FORMEL LABS PRIVATE LIMITED

DEPARTMENT- PRODUCTION

OPERATIONAL QUALIFICATION PROTOCOL

Equipment. TRAY DRYER Effective Date

Protocol No. FL1/OQ/P/MM-001/001-00

PROTOCOL SIGNATURE PAGE:

This protocol Operational Qualification (OQ) has been developed and the individuals listed below have
reviewed the document and agree with its content and with their signature grant approval for
qualification activity to be performed.

OPERATIONAL QUALIFICATION PROTOCOL APPROVAL

Activity Name Designation Signature Date

Prepared by
(PD)

Checked by
(PD)

Checked by
(ENG)

Approved by
(QA)

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 FORMEL LABS PRIVATE LIMITED

DEPARTMENT- PRODUCTION

OPERATIONAL QUALIFICATION PROTOCOL

Equipment. TRAY DRYER Effective Date

Protocol No. FL1/OQ/P/MM-001/001-00

1.0 Purpose:
The purpose of this protocol is to provide guideline and evidence for operational
qualification of multimill (ID No.- A/PD/MM-001) located at Production Block – A.
2.0 Scope:

This protocol is applicable for operational qualification of Multimill available in.

3.0 Responsibilities:

3.1 Production Department

a) To prepare Operational qualification protocol.
b)To execute the operational qualification activity as per approved protocol.
3.2 Engineering Department
a) To provide necessary support during execution of qualification activity.
3.3 Quality Assurance Department
a) To review and approve Operational qualification protocol.

4.0 EQUIPMENT NAME

MULTIMILL

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 FORMEL LABS PRIVATE LIMITED

DEPARTMENT- PRODUCTION

OPERATIONAL QUALIFICATION PROTOCOL

Equipment. TRAY DRYER Effective Date

Protocol No. FL1/OQ/P/MM-001/001-00

5.0 EQUIPMENT CODE

A/PD/MM-001
6.0 EQUIPMENTS / SYSTEM DESCRIPTION

Item / Facility Observed Checked

Sr. No. Specifications Observations
description By By
Material of
1. SS 316
Construction
Capacity of
2. 50 Kg/Hr.
Equipment
Manufacturer M/S Grover
3.
Name Holdings.
Location of Production Block -
4.
Equipment A Ground Floor

7.0 OPERATING CONDITIONS

Sr. No. Test of Condition

1. Note the installation qualification report number: ……………………………………….

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 FORMEL LABS PRIVATE LIMITED

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OPERATIONAL QUALIFICATION PROTOCOL

Equipment. TRAY DRYER Effective Date

Protocol No. FL1/OQ/P/MM-001/001-00

2. Ensure that SOP is available for Operation of Multimill……………………………….

3. Ensure that SOP is available for cleaning of Multimill. ………………………………..
4. Ensure that Equipment uses log book is available for Multimill ………………………
Ensure that SOP is available for maintenance of Multimill.
5.
………………………………….

8.0 ATTACHMENTS

1. Calibration Certificate of Clamp meter.

2. Calibration Certificate of Tachometer.

9.0 TEST FOR OPERATIONAL QUALIFICATION

 Pre-Operational checklist
Sr. No. Checkpoint Yes / No
1. Verify installation qualification is completed
2. Verify earthing and bonding is proper.
3. Sufficient lighting is provided in surrounding area.
4. Ensure ON and OFF switches are working properly.
5. Check the motor and pulley is working properly.
6. Ensure all the moving parts are guarded.
7. Check control panel is installed and electrical connection is provided.

 Instrument calibration list

Sr. Name instrument Instrument ID No. Observation Observed Checked

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 FORMEL LABS PRIVATE LIMITED

DEPARTMENT- PRODUCTION

OPERATIONAL QUALIFICATION PROTOCOL

Equipment. TRAY DRYER Effective Date

Protocol No. FL1/OQ/P/MM-001/001-00

Calibration Calibration
No By By
date due date

1. Clamp meter DCM-001

2. Tachometer TM-001

 RPM, Direction of Rotation and Motor current.

Specification: RPM: 2800, Rotation: Clock wise, Current: 21 Amps.
Acceptance criteria: RPM: 2800+5, Rotation: Should be clock wise.
Current: Should not be more than 21 Amps.

Observed Checked
Sr. No Activity Observation
By By
Machine should be start by pressing
RPM ________________
1. the ON switch on control panel.
Rotation: _____________
Check RPM and rotation of motor.
Motor Current
2. Check the motor current. __________amps.

3. Machine should stop by pressing

the OFF switch on the control panel

 Equipment functioning verification without load

Sr. Test Acceptance Observation Observed Checked
No. Criteria / By By

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 FORMEL LABS PRIVATE LIMITED

DEPARTMENT- PRODUCTION

OPERATIONAL QUALIFICATION PROTOCOL

Equipment. TRAY DRYER Effective Date

Protocol No. FL1/OQ/P/MM-001/001-00

Specification
Machine should be
start forward
For starting Multimill
1 direction by pressing
in forward direction
the green button on
starter
Machine should stop
For stopping
2 by pressing the red
Multimill
button on starter.
Machine should be
For starting Multimill start reverse direction
3
in reverse direction by pressing black
button on the starter
Check the current
__________ Amps
drawn without load

 Equipment functioning verification with load

Acceptance
Sr. Criteria / Observed Checked
Test Observation
No. Specificatio By By
n

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 FORMEL LABS PRIVATE LIMITED

DEPARTMENT- PRODUCTION

OPERATIONAL QUALIFICATION PROTOCOL

Equipment. TRAY DRYER Effective Date

Protocol No. FL1/OQ/P/MM-001/001-00

Charge 25 kg. coarse powder into Multimill and run the Multimill r starting
Multimill in forward direction

i. Should be
Vibration of Multimill
No Vibration

1 Should be
ii.
Abnormal Sounds No abnormal
sound

iii. Check the current drawn __________

with load Amps

2.0 DEVIATION REPORT

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 FORMEL LABS PRIVATE LIMITED

DEPARTMENT- PRODUCTION

OPERATIONAL QUALIFICATION PROTOCOL

Equipment. TRAY DRYER Effective Date

Protocol No. FL1/OQ/P/MM-001/001-00

 Deviation if any:

 Justification of Deviation:

 Conclusion:

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 FORMEL LABS PRIVATE LIMITED

DEPARTMENT- PRODUCTION

OPERATIONAL QUALIFICATION PROTOCOL

Equipment. TRAY DRYER Effective Date

Protocol No. FL1/OQ/P/MM-001/001-00

3.0 SUMMARY AND CONCLUSION

___________________________________________________________________________

___________________________________________________________________________

___________________________________________________________________________

___________________________________________________________________________

___________________________________________________________________________

___________________________________________________________________________

___________________________________________________________________________

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___________________________________________________________________________

___________________________________________________________________________

___________________________________________________________________________

___________________________________________________________________________

___________________________________________________________________________

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 FORMEL LABS PRIVATE LIMITED

DEPARTMENT- PRODUCTION

OPERATIONAL QUALIFICATION PROTOCOL

Equipment. TRAY DRYER Effective Date

Protocol No. FL1/OQ/P/MM-001/001-00

Prepared By Checked By
Sign & Date Sign & Date

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