OPERATIONAL QUALIFICATION PROTOCOL No.

:
PROTOCOL CUM REPORT
FOR
DYNAMIC PASS BOX
PHARMA DEVILS

OPERATIONAL QUALIFICATION
PROTOCOL CUM REPORT
FOR
DYNAMIC PASS BOX

EQUIPMENT ID. No.

LOCATION
External Corridor to Washing & Sterilization Area
DATE OF QUALIFICATION

SUPERSEDES PROTOCOL No. NIL

 OPERATIONAL QUALIFICATION PROTOCOL No.:
PROTOCOL CUM REPORT
FOR
DYNAMIC PASS BOX
PHARMA DEVILS

PROTOCOL CONTENTS

S.No. TITLE PAGE No.

1.0 PROTOCOL PRE-APPROVAL 3

2.0 OBJECTIVE 4

3.0 SCOPE 4

4.0 RESPONSIBILITY 5

5.0 EQUIPMENT DETAILS 6

6.0 SYSTEM DESCRIPTION 6

7.0 PRE-QUALIFICATION REQUIREMENTS 7

8.0 CRITICAL VARIABLES TO BE MET 8

9.0 REFERENCES 11

10.0 DOCUMENTS TO BE ATTACHED 11

11.0 DEVIATION FROM PRE-DEFINED SPECIFICATION, IF ANY 11

12.0 CHANGE CONTROL, IF ANY 11

13.0 REVIEW (INCLUSIVE OF FOLLOW UP ACTION, IF ANY) 12

14.0 CONCLUSION 12

15.0 RECOMMENDATION 12

16.0 ABBREVIATIONS 13

17.0 PROTOCOL POST APPROVAL 14

 OPERATIONAL QUALIFICATION PROTOCOL No.:
PROTOCOL CUM REPORT
FOR
DYNAMIC PASS BOX
PHARMA DEVILS

1.0 PROTOCOL PRE – APPROVAL:

INITIATED BY:

DESIGNATION NAME SIGNATURE DATE

OFFICER/EXECUTIVE
(QUALITY ASSURANCE)

REVIEWED BY:

DESIGNATION NAME SIGNATURE DATE

HEAD
(PRODUCTION)
HEAD
(ENGINEERING)

APPROVED BY:

DESIGNATION NAME SIGNATURE DATE

HEAD
(QUALITY ASSURANCE)
 OPERATIONAL QUALIFICATION PROTOCOL No.:
PROTOCOL CUM REPORT
FOR
DYNAMIC PASS BOX
PHARMA DEVILS

2.0 OBJECTIVE:
 To verify that the equipment operates in accordance with the design and user requirements as
defined by set Acceptance Criteria and complies with relevant cGMP Requirements.
 To verify the Operational features of Dynamic Pass Box and to ensure that it produces desired
Quality & rated output according to manufactures specifications.
 To verify all the Operational features from user point of view of the Equipment, Cleaning Procedure,
Start up & Shut down Procedure and Safety Features.

3.0 SCOPE:
 The scope of this operational qualification protocol cum report is limited to qualification of
Dynamic Pass Box (Make – ……...) installed between External corridor to Washing & Sterilization
Area.
 This Protocol will define the methods and documentation used to perform OQ activity the Dynamic
Pass Box for OQ. Successful completion of this Protocol will verify that Dynamic Pass Box meet all
acceptance criteria and ready for Performance Qualification.
 OPERATIONAL QUALIFICATION PROTOCOL No.:
PROTOCOL CUM REPORT
FOR
DYNAMIC PASS BOX
PHARMA DEVILS

4.0 RESPONSIBILITY:
The Validation Group, comprising of a representative from each of the following departments, shall be
responsible for the overall compliance of this Protocol cum Report:
DEPARTMENTS RESPONSIBILITIES
Quality Assurance  Initiation, Approval and Compilation of the Operational Qualification
Protocol cum Report.
 Co-ordination with Production and Engineering to carryout Operational
Qualification.
 Monitoring of Operational Qualification Activity.
 Post Approval of Operational Qualification Protocol cum Report after
Execution.
Production  Review & Pre Approval of Operational Qualification Protocol cum Report.
 To Co-ordinate and support for Execution of Qualification study as per
Protocol.
 Post Approval of Operational Qualification Protocol cum Report after
Execution.
Engineering  Review & Pre Approval of Operational Qualification Protocol cum Report.
 Co-ordination, Execution and technical support in Dynamic Pass Box
Operational Qualification Activity.
 Calibration of Process Instruments.
 Responsible for Trouble Shooting (if occurs during execution).
 Post Approval of Operational Qualification Protocol cum Report after
Execution.
 OPERATIONAL QUALIFICATION PROTOCOL No.:
PROTOCOL CUM REPORT
FOR
DYNAMIC PASS BOX
PHARMA DEVILS

5.0 EQUIPMENT DETAILS:

Equipment Name Dynamic Pass Box
Equipment
Manufacturer’s Name
Model CP- DPB-2’x2’ x2’
Supplier’s Name
Location of Installation External corridor to Washing & Sterilization Area

6.0 SYSTEM DESCRIPTION:

Dynamic pass box are installed between two rooms, generally clean room & non clean room. Through
which the materials are transferred from one room to another to protect the interference and is equipped
with interlocking system. Only one door can be opened at a time.
The system is equipped with UV Light, sandwich doors with viewing window, and interlocking between
the doors. Pass box will act as a barrier between different class area to maintain the integrity of the area.
Switch ON the main switch. Switch ON the UV light 20 mins in before starting the works.
To open the door gently turns the round handle to right and to close press the door smoothly inside so
that the door will be locked. After shifting the material inside close the door gently and press the buzzer
to intimate the person at other end.
 OPERATIONAL QUALIFICATION PROTOCOL No.:
PROTOCOL CUM REPORT
FOR
DYNAMIC PASS BOX
PHARMA DEVILS

7.0 PRE – QUALIFICATION REQUIREMENTS:

7.1 Verification of Documents:
 DQ Protocol Cum Report
 IQ Protocol cum Report
 SOP for Operation & Cleaning of Dynamic pass box
 SOP for Preventive Maintenance of Dynamic pass box

7.1.1 Procedure:
 Verify the above mentioned documents for availability, completeness and approval status
 If any deviation is observed the same has to be recorded giving reasons for deviation and approved.
Deviation should be approved by Authorized person.
 Approved Drawings and supporting documents would form a part of the OQ Protocol cum report.

7.1.2 Acceptance Criteria:

All the documents should be available, complete and approved by respective authorities.
 OPERATIONAL QUALIFICATION PROTOCOL No.:
PROTOCOL CUM REPORT
FOR
DYNAMIC PASS BOX
PHARMA DEVILS

8.0 CRITICAL VARIABLES TO BE MET:

8.1 Verification of documents:
The results of any tests should meet the limits and acceptance criteria specified in the test documents.
Any deviations or issues should be rectified and documented prior to OQ commencing.
CHECKED BY
COMPLETED
S.No. DOCUMENT NAME DOCUMENT/SOP NO. (ENGINEERING)
(YES/NO)
SIGN/DATE
1. DQ Protocol Cum Report

2. IQ Protocol Cum Report

3. SOP for Operation & Cleaning
of Dynamic pass box.
4. SOP for Preventive
Maintenance of Dynamic pass
box

8.2 Test Equipment Calibration:

EQUIPMENT/
EQUIPMENT/ CALIBRATION OBSERVED BY
INSTRUMENTS DUE ON
INSTRUMENT ID ON SIGN / DATE
NAME

Checked By Verified By
(Production) (Quality Assurance)
Sign/Date: …………………… Sign/Date: ……………………

Inference:
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………

Reviewed By
(Manager QA)
Sign/Date: ……………………
 OPERATIONAL QUALIFICATION PROTOCOL No.:
PROTOCOL CUM REPORT
FOR
DYNAMIC PASS BOX
PHARMA DEVILS

8.3 Operational and Functional Checks:

Operate the Dynamic Pass Box as per Manufacturer’s Manual/SOP and Check for the following
functions of the Equipment. The Equipment should function as desired.
OBSERVED BY
OPERATIONAL
ACCEPTANCE CRITERIA OBSERVATION (ENGINEERING)
CHECKS
(SIGN/DATE)
Blower ON / OFF
Press Switch ON Position Blower should be started & blow
the air.
Press Switch OFF Position Blower should be Stopped.

Function of Magnehelic Gauge

Press Switch ON Position Remarkable deflection of needle
of Blower. should be observed in
Magnehelic gauge.
Deflection should be started from
Zero set point.
UV Light ON / OFF
Press Switch ON Position UV Light should get ON.
Press Switch OFF Position UV Light should get OFF.
UV Light Hour Meter
UV Light Switch ON Reading in Hour Meter should be
Started.
UV Light Switch OFF Reading in Hour Meter should be
Stopped.
Light ON / OFF Switch
Press Switch ON Position Light should get ON.
Press Switch OFF Position Light should get OFF.

Checked By Verified By
(Production) (Quality Assurance)
Sign/Date: …………………… Sign/Date: …………………

Inference:
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………

Reviewed By
(Manager QA)
Sign/Date: …………………
 OPERATIONAL QUALIFICATION PROTOCOL No.:
PROTOCOL CUM REPORT
FOR
DYNAMIC PASS BOX
PHARMA DEVILS

8.4 Interlocking:
OBSERVED BY
S. TEST ACCEPTANCE
PARAMETERS OBSERVATIONS (ENGINEERING)
No. PROCEDURE CRITERIA
(SIGN/DATE)
1. Interlocking Open the door of UV Light should get
between doors one side. OFF.
& UV Light.
Close the same UV Light should get
door. ON.
Open the door of UV Light should get
another side. OFF.
Close the same UV Light should get
door. ON.
2. Interlocking Open the door of Both Doors should not
between both one side and at the be opened at the same
side doors. same time try to time.
open the door of
another side

8.5 Power Failure Verification:

Observed By
Item Acceptance Criteria Observation (Engineering)
Sign/Date
Main Power shut down Equipment stops in safe and
secure condition

Main Power Restored Equipment can be restarted with

no problems or adverse
conditions.

Checked By Verified By
(Production) (Quality Assurance)
Sign/Date: …………………… Sign/Date: …………………

Inference:
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
Reviewed By
(Manager QA)
Sign/Date: ………….………
\
 OPERATIONAL QUALIFICATION PROTOCOL No.:
PROTOCOL CUM REPORT
FOR
DYNAMIC PASS BOX
PHARMA DEVILS

9.0 REFERENCES:

 Design Qualification Party Document

 Installation Qualification Party Document
 Operation Qualification Party Document

10.0 DOCUMENTS TO BE ATTACHED:

 Any Other Relevant Documents.

11.0 DEVIATION FROM PREDEFINED SPECIFICATION IF, ANY:

………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
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12.0 CHANGE CONTROL, IF ANY:

………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………

13.0 REVIEW (INCLUSIVE OF FOLLOW UP ACTION, IF ANY ):

………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
 OPERATIONAL QUALIFICATION PROTOCOL No.:
PROTOCOL CUM REPORT
FOR
DYNAMIC PASS BOX
PHARMA DEVILS

14.0 CONCLUSION:
………………………………………………………………………………………………………………
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15.0 RECOMMENDATION:
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
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16.0 ABBREVIATIONS:

cGMP : Current Good Manufacturing Practice

DQ : Design qualification
DYP : Dynamic Pass Box
ID. : Identification
IQ : Installation Qualification
Ltd. : Limited
mm : Millimeter
Nos. : Number
OQ : Operational Qualification
PO : Purchase Order
Pvt. : Private
 OPERATIONAL QUALIFICATION PROTOCOL No.:
PROTOCOL CUM REPORT
FOR
DYNAMIC PASS BOX
PHARMA DEVILS

17.0 PROTOCOL POST APPROVAL:

INITIATED BY:
DESIGNATION NAME SIGNATURE DATE

OFFICER/EXECUTIVE
(QUALITY ASSURANCE)

REVIEWED BY:

DESIGNATION NAME SIGNATURE DATE

HEAD
(PRODUCTION)
HEAD
(ENGINEERING)

APPROVED BY:

DESIGNATION NAME SIGNATURE DATE

HEAD
(QUALITY ASSURANCE)