HVAC Installation Qualification Protocol - IVT - GMP - Qualification

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HVAC Installation Qualification Protocol | IVT
By Miguel Montalvo Apr 23, 2013 5:16 pm EDT
Installation Quali cation Protocol Protocol No.

Title: HVAC E ective Date
Company X Revision # 1
APPROVAL PAGE
System HVAC
Location Company X, Inc., Address
Protocol Prepared By:
Name/Title Signature Date
Protocol Reviewed By:
Protocol Technical Reviewed By:
Protocol Approved By:
https://www.ivtnetwork.com/article/hvac-installation-qualification-protocol 1/26
Table Of Contents
1.0 SYSTEM OVERVIEW

2.0 SYSTEM BOUNDARY
3.0 OBJECTIVE
4.0 SCOPE
5.0 QUALIFICATION STUDY OVERVIEW
6.0 RESPONSIBILITY
7.0 PREREQUSITES
8.0 ACRONYMS
9.0 DEFINITIONS
10.0 GENERAL DOCUMENTATION REQUIREMENTS
11.0 DATA COLLECTION AND DOCUMENTATION PROCEDURES
12.0 INSTALLATION QUALIFICATION TEST REQUIREMENTS
REQUIREMENTS
13.0 REFERENCES
Index Of Attachments
ATTACHMENT 1 – Personnel Identi cation List

ATTACHMENT 2 – Test Equipment Identi cation/Calibration
ATTACHMENT 3 – Test Equipment Operation
ATTACHMENT 4 – Equipment / Component Veri cation
ATTACHMENT 5 – Utilities Veri cation
ATTACHMENT 6 – Support Documentation - Equipment/System Speci cations
ATTACHMENT 7 – Support Documentation - Submittals
ATTACHMENT 8 – Support Documentation – Purchase Orders
ATTACHMENT 9 – Support Documentation – Equipment Manuals
ATTACHMENT 10 – Support Documentation - Equipment/System Drawings
ATTACHMENT 11 – Support Documentation - Equipment/System Standard Operating Procedures
ATTACHMENT 12 – Support Documentation - Equipment/System Calibration Procedures
ATTACHMENT 13 – Support Documentation - Equipment/System Calibration Program
ATTACHMENT 14 – Maintenance - Spare Parts List
ATTACHMENT 15 – Maintenance - Lubricant Veri cation
1.0 SYSTEM OVERVIEW
History
The AHU-6 and MAU-1 HVAC system includes Air Handling Unit (AHU-6) and Make Up Air Unit (MAU-
1). AHU-6 was purchased from York International in October 1994. AHU-6 was designed and
installed to supply recirculating air to rooms: 123–125. MAU-1 was purchased as part of the
building and operated to supply make up air to the AHU-6 and rooms 120-125, 111, 113, 114, 117,
118,and both service corridors.
Description
The major equipment / components of the AHU-6 and MAU-1 HVAC system include Air Handler Unit
AHU-6, Make Up Air Unit MAU-1, Humidi er H-1, twelve (12) reheat coils RHC-1-RHC-9 and RHC-19 –
RHC-21 and fourteen (14) exhaust fans EF-1 - EF-12, and EF-15 - EF-17.
AHU–6 is a recirculating air handling unit, which provides a constant volume of air ow to rooms
123,124, and 125. It is equipped with a Pre Cooling coil, Preheat coil and 65% e ciency air lters.
AHU-6 provides air ow using outside air from MAU-1 mixed with return air.
MAU-1 provides conditioned air to rooms 111, 113, 114, 117, 118, and 120-125 utilizing 100%
outside air. It is equipped with one (1) reheat coil and two (2) cooling coils. It has 35% e ciency pre-
lters and 95% e ciency bag lters, it also utilizes eleven (11) Variable Air Volume controllers VAV-
A, B, C, D, E, F, G, H and VAV-j, K and L. one (1) Steam Humidi er H-1 located in the supply air duct
downstream from MAU-1 provides humidi cation
The system is designed to provide personnel comfort. Performance criteria for the system are:
Temperature: 70°F ± 5°F
Humidity: 20-80% R.H.
Rationale
This protocol will be performed utilizing 21 CFR 210 & 211, ICH Q-7A Good Manufacturing Practice
Guidance for Active Pharmaceutical Ingredients, August 2001,.
Upon nal approval of this IQ Protocol and Summary Report it will replace the previous IQ study
and render it obsolete. The system will also be placed under formal change control in accordance
with Company XChange Control Program summarized in Standard Operating Procedure
DNAP/QM/012 entitled “Change Control System”.
2.0 SYSTEM BOUNDARY
The system boundary is de ned as the supply utility service rst point of contact with the
system/equipment being installation quali ed. In most cases this is interpreted as the rst inlet
manual valve or motor control/electrical panel providing supply of said utility.
Supplied Utilities ID Number Description
Compressed Instrument Inlet at respective valve Supply air to all applicable

Air pneumatic valves on the
AHU-6

Air pneumatic valves on the
MAU-1.
Low Pressure Steam Inlet at respective valve Supply to appropriate inlets

of H-1

Air pneumatic valves on all VAV
boxes: 1-9,19-21.
Chilled Water In-AHU-6 CHWS-18 Supply to Cooling Coil-
Chilled Water Out-AHU-6 CHWR-19 Return from Cooling Coil
Hot Water In-AHU-6 HWS-2 Supply to hot water coil-
Hot Water Out-AHU-6 HWR-2 Return from hot water coil
Low Pressure Steam To Be Field Veri ed Return from steam reheat

Out-MAU-1 coil
Low Pressure Steam In- To Be Field Veri ed Supply to steam reheat coil-
MAU-1
Chilled Water Out-MAU- To Be Field Veri ed Return from cooling coil

1
Hot Water In-RHC-1 To Be Field Veri ed Supply to hot water coil
Hot Water Out-RHC-1 To Be Field Veri ed Return from hot water coil
Chiller-1 To Be Field Veri ed Outlet to respective Valve
Hot Water Boilers (7) To Be Field Veri ed Outlet to respective Valves
Low pressure Steam To Be Field Veri ed Outlet to respective Valves

Boilers (10)
Electrical AHU-6 Main Breaker Supply to Unit
Electrical MAU-1 Main Breaker Supply to Unit
3.0 OBJECTIVE
The intent of this Installation Quali cation (IQ) is to provide a complete inventory of major
equipment and/or components installed on the HVAC AHU-6 and MAU-1 system and to ensure that:
Major components are those as speci ed in system manuals, contractors’ submittals, original
purchase orders or approved equivalents. These major components will be veri ed during
execution of this protocol.
All critical instruments are calibrated and placed within the calibration program as de ned in
MF/SOP/178.
Operation manuals for the system or equipment are identi ed and available.
Required spare parts are identi ed
System or equipment maintenance requirements are clearly de ned and documented and
are placed in the Preventative Maintenance Program as de ned in MF/SOP/179.
System or equipment cleaning procedures are established and current.
Lubricants will be identi ed and evaluated for acceptability during execution of this protocol.
As-built drawings re ect the actual installation of the system or equipment installed on (HVAC
AHU-6 and MAU-1 system).
4.0 SCOPE
This protocol will be limited to the HVAC AHU-6 & MAU-1 System at Company X, Inc., Address
5.0 QUALIFICATION STUDY OVERVIEW
During the execution of this protocol, determination of the calibration frequencies and formalized
procedures will be provided to AAC Consulting Group, Inc. (AAC) by Company X, Inc. Company X will
calibrate all instrumentation requiring calibration with traceability to NIST and certi cates of
calibration provided to AAC for inclusion in the applicable section of this protocol.
The operation of AHU-6 and MAU-1 are controlled by Johnson Controls’ Metasys Air Handling Unit
Controllers with sensors monitoring air/water temperature, humidity and air/water pressure. The
operation is monitored through the use of the Metacomm system as a Building Management
System (BMS). Metasys VAV Controllers are provided for the control of each VAV box. The BMS
control system will be quali ed in a separate protocol, as part of the Computer System Validation
(CSV).
The Operational Qualifcation of this system will be performed in accordance with protocol #
MF/VAL/OQ/013/PRO entitled “Operational Quali cation of HVAC AHU-6 and MAU-1 System.
6.0 RESPONSIBILITY
6.1 Validation Department:
6.1.1 Prepare and submit the protocol for approval in accordance with current industry
standards, regulatory requirements, and approved Standard Operating Procedures.
6.1.2 Perform and coordinate the execution of the protocol and recording of all raw data.
6.1.3 Review deviations and support the preparation of all corrective action reports that
may be required to resolve discrepant situations.
6.1.4 Prepare and/or coordinate the preparation of a nal test report analyzing and
summarizing the data and submit for review and approval.
6.2 AAC Consulting Group:
6.2.1 Provide technical input into the preparation of the test protocol in accordance with
cGMPs, industry, USFDA standards and guidelines, and Company Xapproved Standard
Operating Procedures. Provide expert review of the nished protocol and procedures.
6.2.2 Assist in the performance of the execution of the test protocol and
recording/analysis of the test results.
6.2.3 Assist in the preparation of deviation reports and recommend corrective actions to
resolve discrepant situations that may arise during execution of the test protocol.
6.2.4 Assist in the preparation of a nal report and provide input as to the conclusions
summarizing the study and submit to Company Xmanagement for review and approval.
6.3 Manufacturing:
6.3.1 Review and approve the test protocol.
6.3.2 Provide quali ed personnel to assist with the execution of the protocol and the
collection of samples.
6.3.3 Assist in preparation of deviation reports and recommend corrective action to

resolve discrepant situations that may arise during execution of the protocol.
6.3.4 Review and approve the nal report.
6.4 Engineering and/or Facilities Department:
6.4.1 Review and approve the test protocol.
6.4.2 Provide documentation required for the generation and execution of the protocol.
6.4.3 Provide equipment that has been commissioned and functional as speci ed by Site
Acceptance Test Report.
6.4.4 Provide assistance in evaluating and resolving equipment malfunctions that may be
encountered during execution of the protocol.
6.5 Quality Assurance:
6.5.1 Review and approve the test protocol in accordance with the approved SOPs, cGMPs,
and current industry guidelines.
6.5.2 Review deviations and support preparation of corrective action reports that may be
required to resolve discrepant situations.
6.5.3 Review and approve the nal report.
7.0 PREREQUSITES
All Standard Operating Procedures required for the execution of this IQ such as maintenance and
calibration of the equipment undergoing IQ must be approved before the IQ Final Report can be
approved.
8.0 ACRONYMS
AHU Air Handling Unit
AL Airlock
CGMP current Good Manufacturing Practice
CPH Changes per hour
CAV Control Air Volume Boxes
EWT Entering Water Temperature
GPM Gallons Per Minute
HEPA High E ciency Particulate Air
HVAC Heating, Ventilating, and Air Conditioning
IWG Inches of Water Gage
LAT Leaving Air Temperature
LWT Leaving Water Temperature
MAU Make-Up Air Unit
NEBB National Environmental Balancing Bureau
NLT Not Less Than
NMT Not More Than
IQ Installation Quali cation
PSI Pound per Square Inch
PM Preventive Maintenance
P&ID Piping and Instrumentation Diagram
RPM Revolutions Per Minute
SOPs Standard operating Procedures
RHC Re Heat Coils
TAB Testing, Adjusting, and Balancing
VAV Variable Air Volume (Dampers or Boxes)
5.0 DEFINITIONS
Acceptance Criteria
The system speci cations and accept/reject criteria that are necessary for making a decision to
accept or reject the system and/or component being quali ed.
Summary of Results
A written summary of the quali cation policies, procedures, and results that may include
graphs and tables to support conclusions and nal acceptance. Also included in this summary
would be documentation of deviations, their investigation, and nal corrective action
implemented to provide nal closure.
System
The term “system” as used in this protocol refers to the series of components, measuring or
control devices and/or equipment, that when working together perform a function considered
critical to the manufacturing of a product intended for medicinal use. Within the scope of this
procedure, the term “system” equally applies to computerized systems, process control
systems, utilities, services, and equipment set-ups (e.g., a reactor-condenser-motor-agitator
set-up).
10.0 GENERAL DOCUMENTATION REQUIREMENTS
10.1 Personnel Identi cation List
10.1.1 All personnel involved in the execution of the protocol must review and complete
Attachment 1.
10.1.2 Curriculum Vitae for all contract personnel have been submitted to the Validation
Department, documented in the Approved Personnel List maintained by the Document
Control Department at Company X, Inc.
10.2 Test Equipment Identi cation/Calibration
10.2.1 Document on Attachment 2 the test equipment that is used during execution of this
protocol.
10.2.2 All test equipment descriptions have been submitted to the Validation Department,
documented in the approved Test Instrument List maintained by the Document Control
Department at Company X, Inc.
10.2.3 All test equipment must be calibrated against standards that are NIST traceable.
Copies of all calibration certi cates for the test equipment must be included in this
attachment.
10.3 Test Equipment Operation
10.3.1 Document on Attachment 3 the SOPs and/or Operation Manuals that are required
for the test equipment used in the execution of this protocol.
10.4 Protocol Corrections
10.4.1 Protocol corrections must be documented by the issuance of a protocol

amendment providing the correct information.
10.5 Raw Data Corrections
10.5.1 Corrections to the raw data must be performed using a single line cross out and
explanation with the person’s initials and date.
10.6 Protocol Deviations
10.6.1 A protocol deviation indicates the discovery of discrepant results, methods,

information, or procedures resulting from the execution of this protocol.
10.6.2 A discrepancy indicates the discovery of discrepant results.
10.6.3 All protocol deviations, discrepancies, and incidents must be documented in

accordance with the current Company X Standard Operating Procedure # MF/SOP/097,
entitled “SOP for the Reporting and Investigation of Investigation on Incidents,
Discrepancies and Deviations”.
10.7 Worksheets
10.7.1 Data, other than laboratory data, must be documented on one of the following
types of worksheets during the execution of the protocol:
10.7.2 Protocol speci c data worksheets, provided in the attachments, are to be used to
record data as required.
10.7.3 The General Data Worksheet provided in the attachments, may be customized for
additional data collection or clari cation.
10.7.4 Copies of raw data from notebook pages or laboratory test results may be attached
to this summary package.
11. DATA COLLECTION AND DOCUMENTATION PROCEDURES
11.1 Installation Quali cation Worksheets
11.1.1 Each IQ worksheet must be completed as directed on the individual worksheet.
11.1.2 The executed IQ worksheet raw data should be compared against the acceptance
criteria, evaluated, and initialed/dated. In the event the acceptance criteria are not met, a
deviation report must be prepared, reviewed and approved, and recorded on the
deviation report log for each occurrence.
11.1.3 All data and results are to be recorded on approved copies of IQ worksheets.
11.1.4 Initial and date each entry and sign and date each worksheet.
11.1.5 Each page of any attachments to the protocol must reference the protocol #,
section and page #, and must be initialed and dated.
11.1.6 A summary of results re ecting conclusions for all veri cations should be prepared
and this document inserted at the beginning of the data package.
11.1.7 The acceptance criteria as indicated for each IQ worksheet must be met.
11.1.8 All speci ed data available at the time of protocol generation should be entered on
each worksheet prior to approval of the protocol. The source of each speci ed value
entered should be referenced in the comment section of each IQ worksheet. All speci ed
data that cannot be determined at the time of protocol generation will be recorded as
“Not speci ed” and the actual value from eld veri cation will be recorded. In the event a
speci ed cannot be eld veri ed a reason should be entered in the comment section of
the form.
12. INSTALLATION QUALIFICATION TEST REQUIREMENTS
12.1 Objective
11.1.1 To verify that the HVAC system and its components have been installed in
accordance with the requirements as indicated in the engineering speci cations and
system drawings.
12.2 Acceptance Criteria
11.2.1 The acceptance criteria as indicated on each protocol attachment must be met or
written explanation providing resolution must be documented.
12.3 Procedure
12.3.1 Complete each protocol attachment as directed on the individual attachment

making sure all required data is properly recorded, initialed, and dated.
12.4 Methods of Data Analysis
12.4.1 Review all completed attachments and compare against the acceptance criteria to
assure that all criteria have been met.
13. REFERENCES
13.1 ISO-14644-1, Cleanrooms and Associated Controlled Environments, Part 1: Classi cation
of Air Cleanliness, First Edition, 1999-05-01.
13.2 ISO-14644-2, Cleanrooms and Associated Controlled Environments, Part 2: Speci cations
for Testing and Monitoring to Prove Compliance with ISO 14644-1, First Edition, 2000-09-15.
13.3 ISO-14644-4, Cleanrooms and Associated Controlled Environments, Part 4: Design,
Construction, and Start-up , First Edition, 2000-04-01.
13.4 ISO-14644-7, Cleanrooms and Associated Controlled Environments, Part 7: Separative

Enclosures (Clean Air Hoods, Gloveboxes, Isolators, Mini-Environments, Draft.
13.5 Title 21, Code of Federal Regulations, Parts 210 and 211
13.6 ICH, Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients,
August 2001.
13.7 Standard Operating Procedures for Reporting and Investigation of Deviations, Metrology
Services, Preventive Maintenance, Change Control System”.
General Data Worksheet
Attachment #__
Use this worksheet for additional data gathering or data clari cation. Include in applicable section
of summary package. NOTE: Make copies of this worksheet as necessary.
Completed by: Date:
Reviewed by: Date:
QA Approval: Date:
ATTACHMENT #1 – Personnel Identi cation List
Each person who will be executing the protocol must complete an entry on this page. Signatures
signify that they have been trained in the protocol and understand the protocol requirements.
NOTE: Make copies of this attachment as necessary.
Name Title Signatures Initials Date
Reviewed by: Date:
QA Approval: Date:
ATTACHMENT 2 – Test Equipment Identi cation/Calibration
Document test equipment not installed on the equipment/system being quali ed that are required
for execution of this protocol. NOTE: Make copies of this attachment as necessary.
Test Equipment Calibration
Description Model # Serial # Tag # Last Cal Cal Due Initials

Date Date Date
Acceptance Criteria Criteria Met? Initials

(Yes/No/NA) Date
The test equipment is calibrated and the calibration is

current.
The calibration standards are traceable to NIST.
A copy of the calibration certi cation(s) for the test

equipment used is attached.
Comments:
Completed by: Date:
Reviewed by: Date:
QA Approval: Date:
ATTACHMENT 3 – Test Equipment Operation
Document SOPs and/or Operation Manuals that are required for operation of the test equipment
used in the execution of this protocol and verify they are current. NOTE: Make copies of this
attachment as necessary.
Document Title E ective Current and Initial/Date

# Date Documented?
(Yes/No)
Completed by: Date:
Reviewed by: Date:
QA Approval: Date:
ATTACHMENT 4 – Equipment / Component Veri cation
(one per each main component including instrumentation/Controls)
Description AIR HANDLING UNIT AHU-6
Speci ed1 Actual Initial/Date
Type A-Series
Location Mezzanine above
Room 124
ID # AHU-6
Manufacturer York International
Model # AP80FSFCV12X12
Serial # CADM-005952
Capacity Rating 3400 CFM
Dimensions (L*W*H) 126”x 53”x 43”
Acceptance Criteria Criteria Met? Initial/

(Yes/No/NA) Date
Actual values conform to speci ed values.
Justi cations are provided for actual values that cannot be

eld veri ed.
1
Comments Speci ed values taken from Dwg # H-04-rev 2, PO # 30563-05, York
International I/O/M Manual, 100.09-nom1.
Completed by: Date:
Reviewed by: Date:
QA Approval: Date:
ATTACHMENT 5 – Utilities Veri cation
Document Hot Water requirements for the applicable equipment/system undergoing IQ. Also
document speci c connections to the facility steam supply. List sources for any speci ed
information recorded on this page in comments. All information recorded as actual is from eld
veri cation unless recorded as otherwise in comments. NOTE: Actual information, such as
pressure, should be measured where possible.
Description / Type ( X ) Plant ( ) Clean

Purpose
Item Speci ed1 Actual Initial/Date
Source Boiler (7) HydroTherm-

MultiTemp
Regulated 18 PSI
Pressure
Temp 173 °F
Method of Joining To be eld veri ed

(Yes/No/NA) Date
Actual values conform to speci ed values.
Justi cations are provided for actual values that cannot be

eld veri ed.
Dielectric Unions are present between piping of dissimilar

metals.
Comments
Completed by: Date:
Reviewed by: Date:
QA Approval: Date:
ATTACHMENT 6 – Support Documentation - Equipment/System Speci cations
Document associated equipment/system speci cations including, manufacturing speci cations,

vendor audits, Factory Acceptance Testing, and inspection reports for the equipment/system
undergoing IQ. Also, document the equipment/system logbook established for the
equipment/system undergoing IQ. NOTE: Make copies of this attachment as necessary.
NOTE: For computer related systems, document associated speci cations including computer
system validation plan, process description (user requirements), functional requirements, design
speci cation, software description and change control history.
Type Title/Description Doc. # Location Initial/Date

(Yes/No/NA) Date
Copies of the manufacturing speci cations for the

equipment/system are attached.
Installed conditions have been veri ed to re ect functional

speci cations.
Equipment/system logbook established.
Filter speci cations and manufacturing validation guides are

available.
HEPA lter speci cations are available.
Computer related systems have speci cations available.
Comments
Completed by: Date:
Reviewed by: Date:
QA Approval: Date:
ATTACHMENT 7 – Support Documentation - Submittals
List the approved submittals as supplied by the contractor or manufacturer supporting the system
and system components. Include a copy of each submittal with this protocol.
Description: Initials
Date

(Yes/No/NA) Date
The submittals have been veri ed to

accurately describe and document the
system being quali ed.
Copies of the approved submittals for

the system and components are
attached.
Comments
Completed by: Date:
Reviewed by: Date:
QA Approval: Date:
ATTACHMENT 8 – Support Documentation - Purchase Orders
List the purchase orders supporting the system and system components. Include a copy of each
purchase order with this protocol.
Description Purchase Order Initials

Number Date
Air Handler AHU-6 30563-05
Variable Air Volume Box 30563-12
Heating/Cooling Coils 30563-05
Exhaust Fans 30563-12
Humidi er H-1 30563-07
(Yes/No/NA) Date
The system being quali ed conforms to the PO

requirements.
Copies of the purchase orders for the system and

system components are attached.
Comments
Completed by: Date:
Reviewed by: Date:
QA Approval: Date:
ATTACHMENT 9 – Support Documentation - Equipment Manuals
Verify that pertinent equipment documentation exists and reference the location where the
document is kept.
Title Location Initials/Date
Acceptance Criteria Criteria Met? Initials/Date

(Yes/No/NA)
The manufacturers equipment manuals are

described above and the location of each manual
is documented.
Comments
Completed by: Date:
Reviewed by: Date:
QA Approval: Date:
ATTACHMENT 10 – Support Documentation - Equipment/System Drawings
Document associated process ow drawings, P&IDs, layout drawings, shop drawings, and any other
pertinent drawings, including all associated equipment, facility, and utility drawings for the
equipment/system undergoing IQ. Verify that the drawings are accurate and su cient to
characterize the equipment/system. Verify that components are physically labeled in accordance
with drawings. Highlight the veri ed portions of the drawings and redline changes as necessary.
All drawings must be veri ed, signed, and dated. Submit any redlined drawings to the Document
Control Group for revision. Include copies of the highlighted, veri ed drawings, redlined copies, and
applicable Document Control Forms with this summary package. NOTE: Make copies of this
attachment as necessary.
necessary.
NOTE: Controller diagrams and wiring diagrams will be documented on separate attachments.
Drawing # Title Rev. Rev. Initial/Date
Date

(Yes/No/NA) Date
Drawing list includes associated equipment, facility, and

utility drawings.
Drawings, with redlines if applicable, are su cient to

characterize equipment/system.
Equipment/system installation corresponds to drawings,

with redlines if applicable.
Components including equipment, valves, and instruments

are physically labeled and labels correspond to drawings,
with redlines if applicable.
Copies of veri ed drawings and redline copies are included

with this summary package.
Drawings have been veri ed, signed, and dated.
Redlined drawings submitted for revision to the Document

Control Group and copy of Document Control form
included with this summary package.
The Document Control Group controls original drawing

les.
Comments
Completed by: Date:
Reviewed by: Date:
QA Approval: Date:
ATTACHMENT 11 – Support Documentation - Equipment/System Standard Operating

Procedures
Document operating SOPs (e.g. operation, maintenance, cleaning and sanitization) associated with
the equipment/system, including controls, undergoing IQ. NOTE: Make copies of this attachment
as necessary.
NOTE: For computer related systems, SOPs should include failure/backup/recovery, security,
system monitoring and maintenance.
Document Title Rev. Rev. Date Initial/Date

#

(Yes/No/NA) Date
List above includes operation, maintenance, cleaning, and

sanitization procedures as applicable that are approved
and current.
Comments
Completed by: Date:
Reviewed by: Date:
QA Approval: Date:
ATTACHMENT 12 – Support Documentation - Equipment/System Calibration Procedures
Page ______ of _______
Document the calibration SOPs associated with the critical instruments on equipment/system,
including controls, undergoing IQ. NOTE: Make copies of this attachment as necessary.
Document Title Rev. Rev. Date Initial/Date

#

(Yes/No/NA) Date
All calibration procedures associated with the critical

instruments on the equipment/system undergoing are
approved and current.
Comments
Completed by: Date:
Reviewed by: Date:
QA Approval: Date:
ATTACHMENT 13 – Support Documentation - Equipment/System Calibration Program
Page ______ of _______
Document the equipment/system components (e.g., instruments, controlling/monitoring switches)

undergoing IQ that require calibration. Verify that these components are entered into calibration
program by reviewing copies of the calibration reports obtained from the Metrology Department.
Ensure that all components requiring calibration have been calibrated and are traceable to National
Institute of Standards and Technology (NIST), the American Society of Testing and Materials (ASTM),
or other applicable standard. Additionally, verify that all calibrated instruments have a calibration
tag. Include copies of the calibration reports with this summary package. NOTE: Make copies of
this attachment as necessary.
NOTE: Instrument veri cation, process instrument materials of construction veri cation, and digital
sensors and controlling/monitoring switches list will be documented on separate attachments.
Component Associated Associated Rev. Rev. Cal Last Initial/

Asset # and Cal Cal Date Frequency Cal Date
Description Procedure Procedure Date
# Title

(Yes/No/NA) Date
Components that require calibration are entered into the

calibration program.
Components are traceable to applicable standard.
Components have a tag indicating last cal date and cal due
date.
Components are calibrated by the conclusion of protocol

execution.
Copies of the calibration reports are included with this

summary package.
Comments
Completed by: Date:
Reviewed by: Date:
QA Approval: Date:
ATTACHMENT 14 – Maintenance - Spare Parts List
Page ______ of _______
Document spare parts lists for the applicable equipment/system and associated controls
undergoing IQ. Document the location of the manufacturer’s recommended list (e.g., installation
manual). NOTE: Make copies of this attachment as necessary.
Equipment/ Spare Parts List Location Initial/

System Name Date
AHU-6 Form 100.09-MOM1 York International O/M

Manual
MAU-1 4/5/95 Mammoth O/M Manual

(Yes/No/NA) Date
Locations of manufacturer’s recommended spare parts

lists are documented.
Comments
Completed by: Date:
Reviewed by: Date:
QA Approval: Date:
ATTACHMENT 15 – Maintenance - Lubricant Veri cation
Page ______ of _______
Document lubricants, used with equipment/system undergoing IQ. Using information obtained
from the Quality Assurance or Maintenance Departments, the manufacturer, and/or the supplier,
verify the lubricants are acceptable for their intended use. Include documentation supporting the
acceptability of the lubricants with this summary package. List sources for any information
recorded on this page in comments. NOTE: Make copies of this attachment as necessary.
Lubricant Type Purpose Acceptable? Initial/

and Manufacturer (Yes/No) Date

(Yes/No/NA) Date
All lubricants are acceptable for intended use.
Documentation supporting the acceptability of the

lubricants is included with this summary package.
Comments
Completed by: Date:
Reviewed by: Date:
QA Approval: Date:
Download the accompanying presentation, "E"E ective Quali cation of Critical Utilities,"
Utilities,"
presented at IVT's Validation and cGMP Week Puerto Rico, San Juan, Puerto Rico, July 2011.
PRINTER-FRIENDLY VERSION
Tags: GMP - Quali cation,

cation Facilities Utlities and Equipment

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7/15/2020 HVAC Installation Qualification Protocol | IVT - GMP - Qualification

ABOUT IVT MEMBERSHIP JOURNALS PRODUCTS EVENTS WHAT'S NEW R

By Miguel Montalvo Apr 23, 2013 5:16 pm EDT

Installation Quali cation Protocol Protocol No.

Location Company X, Inc., Address

Protocol Prepared By:

Name/Title Signature Date

Protocol Reviewed By:

Name/Title Signature Date

Protocol Technical Reviewed By:

Name/Title Signature Date

Protocol Approved By:

Name/Title Signature Date

1.0 SYSTEM OVERVIEW

ATTACHMENT 1 – Personnel Identi cation List

1.0 SYSTEM OVERVIEW

Temperature: 70°F ± 5°F

Humidity: 20-80% R.H.

2.0 SYSTEM BOUNDARY

Supplied Utilities ID Number Description

Compressed Instrument Inlet at respective valve Supply air to all applicable

Compressed Instrument Inlet at respective valve Supply air to all applicable

Low Pressure Steam Inlet at respective valve Supply to appropriate inlets

Compressed Instrument Inlet at respective valve Supply air to all applicable

Chilled Water In-AHU-6 CHWS-18 Supply to Cooling Coil-

Chilled Water Out-AHU-6 CHWR-19 Return from Cooling Coil

Hot Water In-AHU-6 HWS-2 Supply to hot water coil-

Hot Water Out-AHU-6 HWR-2 Return from hot water coil

Low Pressure Steam To Be Field Veri ed Return from steam reheat

Chilled Water Out-MAU- To Be Field Veri ed Return from cooling coil

Hot Water In-RHC-1 To Be Field Veri ed Supply to hot water coil

Hot Water In-RHC-2 To Be Field Veri ed Supply to hot water coil

Hot Water In-RHC-3 To Be Field Veri ed Supply to hot water coil

Hot Water In-RHC-4 To Be Field Veri ed Supply to hot water coil

Hot Water In-RHC-5 To Be Field Veri ed Supply to hot water coil

Hot Water In-RHC-6 To Be Field Veri ed Supply to hot water coil

Hot Water In-RHC-7 To Be Field Veri ed Supply to hot water coil

Hot Water In-RHC-8 To Be Field Veri ed Supply to hot water coil

Hot Water In-RHC-9 To Be Field Veri ed Supply to hot water coil

Hot Water In-RHC-19 To Be Field Veri ed Supply to hot water coil

Hot Water In-RHC-20 To Be Field Veri ed Supply to hot water coil

Hot Water In-RHC-21 To Be Field Veri ed Supply to hot water coil

Chiller-1 To Be Field Veri ed Outlet to respective Valve

Chiller-2 To Be Field Veri ed Outlet to respective Valve

Chiller-3 To Be Field Veri ed Outlet to respective Valve

Hot Water Boilers (7) To Be Field Veri ed Outlet to respective Valves

Low pressure Steam To Be Field Veri ed Outlet to respective Valves

Electrical AHU-6 Main Breaker Supply to Unit

Electrical MAU-1 Main Breaker Supply to Unit

5.0 QUALIFICATION STUDY OVERVIEW

6.1 Validation Department:

6.2 AAC Consulting Group:

6.3.1 Review and approve the test protocol.

6.3.3 Assist in preparation of deviation reports and recommend corrective action to

6.3.4 Review and approve the nal report.

6.4 Engineering and/or Facilities Department:

6.4.1 Review and approve the test protocol.

6.5 Quality Assurance:

6.5.3 Review and approve the nal report.

AHU Air Handling Unit

CGMP current Good Manufacturing Practice

CPH Changes per hour

CAV Control Air Volume Boxes

Dimensions (LWH) 126”x 53”x 43”