CLIENT

M/S ENTRANCE PHARMACEUTICALS

AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF

HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-01 Issue Date.

Revision No. 00 Revision Date NA

INSTALLATION QUALIFICATION
PROTOCOL OF
HEATING VENTILATION & AIR CONDITIONING
SYSTEM

FOR
SYSTEM ID.: AHU-01

PLANT OF
M/S ENTRANCE PHARMACEUTICALS AND RESEARCH
CENTRE
NO.16, OKPOI, SPINTEX ROAD, ACCRA P.O.BOX CT 10805, SPINTEX ROAD,
GHANA.
TABLE OF CONTENTS

BY
M/S. HVAX TECHNOLOGIES PVT. LTD. - MUMBAI

Page 1 of 25
 CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF

HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-01 Issue Date.

Revision No. 00 Revision Date NA

TABLE OF CONTENT

1.0 PROTOCOL APPROVAL SHEET 3

2.0 PURPOSE 4
3.0 SCOPE 4
4.0 RESPONSIBILITIES 4
5.0 DOCUMENTATION PROCEDURE 6
6.0 INSTALLATION QUALIFICATION PROCEDURE 7
7.0 SYSTEM DESCRIPTION 8
8.0 PHYSICAL VERIFICATION 9
9.0 INSPECTION CHECKLIST FOR AHU COMPONENTS 10
10.0 TECHNICAL DATA OF ANCILLARY ITEMS 14
11.0 SAFETY 20
12.0 REFERENCE DOCUMENTS 21
13.0 OBSERVATION DEVIATION DURING INSTALLATION QUALIFICATION 22
14.0 RECOMMENDATION AND CONCLUSION AFTER INSTALLATION QUALIFICATION 23
15.0 POST APPROVAL 24
16.0 ABBREVIATIONS 25

1.0 PROTOCOL APPROVAL SHEET

The Author signature indicates that this document has been prepared in accordance with existing
cGMP standards and adequately reflects the tasks and deliverables necessary during the design phase
in the construction and equipping of pharmaceutical facilities and/or the equipment used therein.

Prepared By (M/s. HVAX Designation Signature Date

Page 2 of 25
 CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF

HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-01 Issue Date.

Revision No. 00 Revision Date NA

Technologies Pvt. Ltd.)

The reviewer’s signature indicates that, this document has been reviewed and it accurately and
completely reflects the tasks and deliverables necessary during the design phase in the construction and
equipping of pharmaceutical facilities and/or the equipment used therein, and that the documentation
and information included complies with applicable regulatory, corporate, divisional / departmental and
cGMP requirements.
The approver’s signature indicates that the documentation and information contained herein complies
with applicable regulatory, corporate, divisional/departmental & cGMP requirements.
Reviewed By
(M/S.Entrance Pharmaceuticals Designation Signature Date
And Research Centre)

Approved By
(M/S.Entrance Pharmaceuticals Designation Signature Date
And Research Centre)

2.0 PURPOSE

To provide the documentary evidences that the HVAC system (AHU-01) installed at of M/S. Entrance
Pharmaceuticals and Research Centre is installed as per design specification.

Reference HVAC DQ Protocol No: - 1944/HVAC/DQ/AHU-01

Page 3 of 25
 CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF

HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-01 Issue Date.

Revision No. 00 Revision Date NA

3.0 SCOPE

This qualification protocol is applicable to the HVAC system (AHU-01) for M/S. Entrance
Pharmaceuticals and Research Centre This was designed & checked by M/S. HVAX
TECHNOLOGIES PVT. LTD.

This document is applicable for HVAC System and catering Areas are Packing Material sampling,
Airlock which meets the Class D.

4.0 RESPONSIBILITIES

 HVAX Technologies Pvt. Ltd.:

 To prepare qualification protocol cum report.

 To submit qualification protocol M/S. Entrance Pharmaceuticals and Research Centre for
approval.
 To record the observation along M/S. Entrance Pharmaceuticals and Research Centre during
execution of the protocol.
 To submit final qualification report to M/S. Entrance Pharmaceuticals and Research Centre for
approval.
 To install the HVAC system as per approved designed specification and at designated place.

 Engineering:

 To review the qualification protocol cum report.

 To get the system installed as per the design specification.
 To provide utilities and supportive services for qualification. (As mentioned in DQ)
 To arrange for the calibration of the instruments for qualification study.
 To assist quality assurance / quality control while qualification study.

 Quality Assurance:

Page 4 of 25
 CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF

HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-01 Issue Date.

Revision No. 00 Revision Date NA

 To review the qualification protocol cum report.

 To record the observation along with engineering & M/S. HVAX TECHNOLOGIES PVT. LTD. as
per designed protocol.
 To verify the compliance of qualification activity as per protocol.

 Engineering Head, GM Quality Assurance:

 To review and approve the qualification protocol and report.

5.0 DOCUMENTATION PROCEDURE

 All documentation work shall be completed concurrently during execution of the qualification.
However, the protocol does not define the sequence of the documentation to be carried out.
 Use indelible blue ink for the recording of observations. (Or as per Client)
 Fill out complete information in the format provided.
 Do not leave any blank space. Enter “N/A” in space that is not applicable.

Page 5 of 25
 CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF

HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-01 Issue Date.

Revision No. 00 Revision Date NA

 Correct the wrong entry by drawing single line through incorrect data, recording the correct data and
then signing and dating the change.
 If any deviation occurred during execution of the protocol, it shall be handled through predefined
procedure.
 After protocol execution, report shall be prepared with following details.
1. Discussion of all studies in observation column.
2. Qualification is successfully completed or not.
3. Conclusion.
4. Recommendation, (if any).

6.0 INSTALLATION QUALIFICATION PROCEDURE

 Ensure that the HVAC is installed at the designated place.

 Check the material of construction (MOC) of all the critical parts.
 Ensure that all safety features are installed.
 Check other details as per the specifications of this protocol and enter the observations.
 Check the Installation Qualification parameters against their specification during installation of the
HVAC as given in the table and record the same.

Page 6 of 25
 CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF

HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-01 Issue Date.

Revision No. 00 Revision Date NA

 Document initial and date after each observation in respective column.

 In case of any deviation, document in “Remarks” column and immediately inform to the department
head for necessary action.
 Document the deviation details in observed deviation section.
 Quality assurance head and department head shall decide whether deviation is acceptable or not.
 If deviation is acceptable and it does not have any potential to impact on operation, initiate for
operation qualification.
 If deviation is not acceptable then inform to M/S. Entrance Pharmaceuticals and Research Centre
Engineering department head for necessary action for attending problems to complete installation
qualification.

7.0 SYSTEM DESCRIPTION

The following are the main features of the system:

This Air handling system having a supply air fan capacity of 1000 CFM which supplies the
Conditioned air to Class ‘D’ Area.

 Manually Operated Return Air Damper.

 Manually Operated Fresh Air Damper.
 G4 (10µ) flange type Pre filter.
 Four Rows deep DX Cooling coil.

Page 7 of 25
 CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF

HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-01 Issue Date.

Revision No. 00 Revision Date NA

 2.86 TR condensing unit.

 Plug type blower having 125 mm WG static pressure.
 2.2 KW 3 phase non flame proof motor.
 F7 (3µ) flange type Fine filter.
 Magnehelic gauges mounted filters
 Ducting made of GI sheet.
 Supply Air Terminal HEPA Box with H-14 filter.
 Return Air Riser
 Nitrile rubber insulation with one side Al foil faced duct insulation.

8.0 PHYSICAL VERIFICATION

Perform the physical verification of each component as mentioned below after receipt of the site for
any damages or dent while transporting.
Acceptance Criteria: Should be no physical damage and dents.

Method of
Sr. No. Items Name Observation Checked By Remarks
Verification

Main AHU
1. Visual Check
Body

Page 8 of 25
 CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF

HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-01 Issue Date.

Revision No. 00 Revision Date NA

AHU Supply air

2. Visual Check
blower

DX Cooling
3. Visual Check
Coil

5. Pre-filters Visual Check

6. Fine Filter Visual Check

Volume control
7. dampers Visual Check
(VCDs)
Supply Air
8. Terminal Visual Check
box

9. Return Air Riser Visual Check

9.0 INSPECTION CHECKLIST FOR AHU COMPONENTS

Sr.
Parameter Acceptance criteria Observation Checked By Remarks
No.

1. GENERAL

HVAX Technologies
Manufacturer
Pvt. Ltd.

System No. AHU – 01

Type of unit Double skin sandwiched

Inside panel thick 0.6 mm thick. Plain GI

Page 9 of 25
 CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF

HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-01 Issue Date.

Revision No. 00 Revision Date NA

Sr.
Parameter Acceptance criteria Observation Checked By Remarks
No.
Outside panel 0.6 mm Pre-coated GI
thick

Panel Thickness 47mm

Drain Pan
SS 304
material

Drain Pan Thick. 20 G

1.A Supply Decker

Capacity (CFM) 1000

Static pressure
125
(mmwg)

Length (mm) 2620

Width (mm) 900

Height (mm) 1700

2. FAN

Type Centrifugal Plug

Make Kruger

Model No. BNC P 355

Fan speed (RPM) 2762

Fan absorbed 1.67 KW

power

Serial No. To be recorded

Page 10 of 25
 CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF

HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-01 Issue Date.

Revision No. 00 Revision Date NA

Sr.
Parameter Acceptance criteria Observation Checked By Remarks
No.

3. MOTOR

Make BBL/SIEMENS/CG

Type Non-Flame proof

KW/Pole 2.2 (2 Pole)

RPM 2900

Serial No. To be recorded

4. DX COOLING COIL

Type DX Coil

Tube Material Copper

Tube Dia. 3/8 Inch

Fin material Aluminum

No. of fins 10-12 Fins per inch

Face area
381 X 483mm
(H x L)
Coil Area
1.97
(Sq. ft.)

Rows deep 4

Header material
Copper
& Size

5. PRE-FILTER

Page 11 of 25
 CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF

HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-01 Issue Date.

Revision No. 00 Revision Date NA

Sr.
Parameter Acceptance criteria Observation Checked By Remarks
No.
Type Flange Type

Make Fine Airsys / Mechmaark

Size 508 x 508 x 51 mm-
(H x W x D) 1Nos.
Efficiency 90%

Serial No. To be recorded

6. FRESH AIR FILTER

Type Flange Type

Make Fine Airsys / Mechmaark

Size (H x W x D) 250 x 250 x 30mm-1Nos.

250 x 250 x 30mm-1Nos.
Efficiency 90%

Serial No. To be recorded

7. CONDENSING UNIT

Make Career

Unit 4 TR

Model 51MSG-048GSF

Qty. 1Nos.

Page 12 of 25
 CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF

HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-01 Issue Date.

Revision No. 00 Revision Date NA

Sr.
Parameter Acceptance criteria Observation Checked By Remarks
No.

8. MICROVEE FILTER

Type Flange Type

Make Fine Airsys / Mechmark

Size (H x W x D) 508 x 508 x 300 mm-

1Nos.
Efficiency 95% (3µ)

Serial No. To be recorded

9. PURGE AIR FILTER

Type Flange Type

Make Fine Airsys/ Mechmark

Size 250x250x30mm - 1Nos.

Efficiency 90%- (10µ)

10.0 TECHNICAL DATA OF ANCILLARY ITEMS

Sr. Acceptance
Parameter Observation Checked By Remarks
No. criteria

1. DUCTS

Material Of sheet Galvanized Steel

24G (0.6mm)
Thickness of Sheet
22G(0.8mm)
Sizing &
1220 x 2438 mm
Construction

Page 13 of 25
 CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF

HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-01 Issue Date.

Revision No. 00 Revision Date NA

Sr. Acceptance
Parameter Observation Checked By Remarks
No. criteria
Silicon sealant
Sealant
(white)

2. DUCT INSULATION

Make Supreme
XLPE insulation
Material with one side Al
foil faced.
Density 28±3 Kg/m3
Thermal
stability@90oC/24 ≤ 5%
hrs
Operating
-40 °C to 115 °C
Temperature
Supply insulation
19mm
Thickness
Return Insulation
13mm

3. DAMPERS

Fine Airsys /
Make
Mechmaark
Manually Operated
Material
Al. Damper
Fresh Air Damper
200 X 200 mm
(H x W)
Purge Air Damper
200 X 200 mm
(H x W)
Return Air
250 X 250 mm
Damper (H x W)
Supply Air
250 X 250 mm
Damper (H x W)
Bypass Air
100 X 500 mm
Damper (H x W)
Page 14 of 25
 CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF

HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-01 Issue Date.

Revision No. 00 Revision Date NA

Sr. Acceptance
Parameter Observation Checked By Remarks
No. criteria

4. FIRE DAMPER
SA AIR /
Make RUSKIN TITUS /
CARYAIRE
MOC Galvanized Steel
Sheet
Size (H x W)
MM / Qty. 250 X 250 mm
(Supply)
Size (H x W)
MM / Qty. 250 X 250 mm
(Return)

5. ROOM PRESSURE

Magnehelic
Instrument
Gauges
Dwyer/Omicron/
Make
Radix
Entrance of the
Location
Room

Range 0-60 Pa

To be recorded
Serial No.

Qty.

6. DIFFERENTIAL PRESSURE ACROSS AHU FILTERS

Magnehelic
Instrument
gauges

Make Dwyer/Omicron

Page 15 of 25
 CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF

HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-01 Issue Date.

Revision No. 00 Revision Date NA

Sr. Acceptance
Parameter Observation Checked By Remarks
No. criteria
0-25 mm of WC
(Pre Filter),
Range
0-50 mm WC
(Fine Filter)

7. SUPPLY AIR TERMINAL BOX

16 gauge
MOC aluminum anodized
extrusion
Make AAF

Perforated Sheet SS 304 18G

Sealant PU at 4 corners

SUPPLY AIR TERMINAL MODULE WITH HEPA FILTERS IN

ROOMS

Type Bottom Loading

Mechmark filtech
Make india private
limited
Imported
Filter Media Submicronic Glass
fiber paper
Initial Pressure 25±10% mm of
Drop WG
Final Pressure
60 mm of WG
Drop

Filter grade H-14

99.999% down to
Efficiency
0.3µ

Sealant Silica Gel

Serial No.
7.1 ROOM NAME SIZE

Page 16 of 25
 CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF

HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-01 Issue Date.

Revision No. 00 Revision Date NA

Sr. Acceptance
Parameter Observation Checked By Remarks
No. criteria
(H x W x D) MM/
QTY (Nos.)
PACKING
610 X 610 X
MATERIAL
81mm-1
SAMPLING
300 X 300 X
AIRLOCK
105mm-1

8. RETURN AIR RISER IN ROOMS

RETURN AIR RISER

SIZE
ROOM NAME (H x W ) MM/
QTY (Nos.)
PACKING
MATERIAL 300 X 100mm-1
SAMPLING
AIRLOCK 300 X 100mm-1

CONDENSING DRAIN TRAY DETAILS

9. CONDENSING DRAIN TRAY

MOC S.S 304

Thickness 20 G

Insulation
19 mm
Thickness

Drain Socket Size 40 mm Dia

10. TEMPERATURE CONTROLLER

Page 17 of 25
 CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF

HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-01 Issue Date.

Revision No. 00 Revision Date NA

Sr. Acceptance
Parameter Observation Checked By Remarks
No. criteria

Make. SELEC

Range 00 to 500C

Qty (Nos) 1

11. TEMPERATURE & RH SENSOR

Make. BELIMO

Qty (Nos) 1 SET

Serial Number

12. RH CONTROLLER

Make. SELEC

Range 0...100%

Qty (Nos) 1

13. VELOCITY SENSOR

Make Omicron

Qty (Nos) 1

Serial Number

Page 18 of 25
 CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF

HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-01 Issue Date.

Revision No. 00 Revision Date NA

Sr. Acceptance
Parameter Observation Checked By Remarks
No. criteria

14. ELECTRICAL PANEL

Material C.R.C.A Sheet

Frame and door work-

Thickness
16 SWG

Cable Entry Bottom Entry

Color Shade RAL 7035

IP 54 for main
Protection
Enclosure.
Gland Plate
14 SWG C.R.C.A Sheet
Thickness
All Switchgear
Schneider
Make

11.0 SAFETY

Sr. Method of Checked

Parameter Acceptance criteria Verification Observation Remarks
No. By

Should not be more

As per
1. Noise level than 90dB at a
Certificates
distance of 1 meter.

2. Vibration Blower should be Visual

isolators mounted on bottom Check
channel frame
supported with
vibration isolators.

Page 19 of 25
 CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF

HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-01 Issue Date.

Revision No. 00 Revision Date NA

Earthing Motor earthing Visual

3.
connections should be providing. Check

12.0 REFERENCE DOCUMENTS

Sr.
Annexure / Documents Annexure No. Checked By
No.

1. Room Data Sheet Annexure-I

2. AHU GA Annexure-II

3. Filter test certificates Annexure-III

4. Motor Certificate Annexure-IV

5. Fan Curve Annexure-V

Page 20 of 25
 CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF

HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-01 Issue Date.

Revision No. 00 Revision Date NA

6. Coil Certificate Annexure-VI

7. AHU Location Layout Annexure-VII

8. Ducting Layout Annexure-VIII

9. RCP Layout Annexure-IX

13.0 OBSERVATION DEVIATION DURING INSTALLATION QUALIFICATION

Details of deviation:

Investigation:

Corrective Action Taken:

Acceptable Yes/No:

Page 21 of 25
 CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF

HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-01 Issue Date.

Revision No. 00 Revision Date NA

Justification for Acceptance:

Deviation Investigated by:

Deviation Approved By (If any):

Department Head / Date Quality Assurance Head/ Date

14.0 RECOMMENDATION AND CONCLUSION AFTER INSTALLATION QUALIFICATION

Recommendation after Installation Qualification

Conclusion after Installation Qualification

Page 22 of 25
 CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF

HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-01 Issue Date.

Revision No. 00 Revision Date NA

Concluded By

15.0 POST APPROVAL

It is hereby certified by the following functionaries that the system stands qualified for Design Qualification
and the system may be released to the next level of qualification activity.

The reviewer’s signature indicates that this document has been reviewed and it accurately and completely
reflects that the tasks and deliverables necessary for validation of the system have been completed
successfully and that the documentation and information included complies with applicable regulatory,
corporate, divisional/ departmental and cGMP requirements.

Reviewed By
(M/S. Entrance Pharmaceuticals And Signature Date
Research Centre.)

Page 23 of 25
 CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF

HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-01 Issue Date.

Revision No. 00 Revision Date NA

The approver’s signature indicates that the documentation and information contained herein complies
with applicable regulatory, corporate, divisional / departmental and cGMP requirements.

Approved By
(M/S. Entrance Pharmaceuticals And Signature Date
Research Centre.)

16.0 ABBREVIATIONS

Sr. No. Abbreviation Description

1 AHU Air Handling Unit

2 CFM Cubic feet per minute

3 cGMP Current Good Manufacturing Practice

4 DQ Design Qualification

5 GI Grey Iron

6 HVAC Heating Ventilation & Air conditioning

7 HEPA High Efficiency Particulate Air

8 Mm Millimeter

9 NA Not applicable

10 URS User Requirement specification

Page 24 of 25
 CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF

HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-01 Issue Date.

Revision No. 00 Revision Date NA

11 TR Ton of Refrigeration

12 ͦ C Degree centigrade

13 % Percentage

14 RCP Room Ceiling Partition

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