PROTOCOL

HVAC Installation Qualification

Protocol | IVT
By
Miguel Montalvo

Apr 23, 2013 2:16 pm PDT

Protocol No.
Installation Qualification Protocol
Title: HVAC Effective Date
Company X
Revision # 1

APPROVAL PAGE

System
HVAC

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

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
13.0 REFERENCES

Index Of Attachments

ATTACHMENT 1 – Personnel Identification List

ATTACHMENT 2 – Test Equipment Identification/Calibration
ATTACHMENT 3 – Test Equipment Operation
ATTACHMENT 4 – Equipment / Component Verification
ATTACHMENT 5 – Utilities Verification
ATTACHMENT 6 – Support Documentation - Equipment/System Specifications
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 Verification

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, Humidifier 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 airflow
to rooms 123,124, and 125. It is equipped with a Pre Cooling coil, Preheat coil and 65%
efficiency air filters. AHU-6 provides airflow 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% efficiency pre-filters and 95% efficiency bag filters, 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 Humidifier H-1 located in the supply air duct downstream from MAU-1 provides
humidification

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 final 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 defined as the supply utility service first point of contact with
the system/equipment being installation qualified. In most cases this is interpreted as
the first inlet manual valve or motor control/electrical panel providing supply of said
utility.

Supplied Utilities ID Number Description

Compressed Instrument Air Inlet at respective valve Supply air to all applicable
pneumatic valves on the AHU-
6

Compressed Instrument Air Inlet at respective valve Supply air to all applicable
pneumatic valves on the
MAU-1.

Low Pressure Steam Inlet at respective valve Supply to appropriate inlets of

H-1

Compressed Instrument Air Inlet at respective valve Supply air to all applicable
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 Out-MAU-1 To Be Field Verified Return from steam reheat coil
Low Pressure Steam In-MAU-1 To Be Field Verified Supply to steam reheat coil-

Chilled Water Out-MAU-1 To Be Field Verified Return from cooling coil

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

Hot Water Out-RHC-1 To Be Field Verified Return from hot water coil

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

Hot Water Out-RHC-2 To Be Field Verified Return from hot water coil

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

Hot Water Out-RHC-3 To Be Field Verified Return from hot water coil

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

Hot Water Out-RHC-4 To Be Field Verified Return from hot water coil

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

Hot Water Out-RHC-5 To Be Field Verified Return from hot water coil

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

Hot Water Out-RHC-6 To Be Field Verified Return from hot water coil

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

Hot Water Out-RHC-7 To Be Field Verified Return from hot water coil

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

Hot Water Out-RHC-8 To Be Field Verified Return from hot water coil

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

Hot Water Out-RHC-9 To Be Field Verified Return from hot water coil
 Hot Water In-RHC-19 To Be Field Verified Supply to hot water coil

Hot Water Out-RHC-19 To Be Field Verified Return from hot water coil

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

Hot Water Out-RHC-20 To Be Field Verified Return from hot water coil

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

Hot Water Out-RHC-21 To Be Field Verified Return from hot water coil

Chiller-1 To Be Field Verified Outlet to respective Valve

Chiller-2 To Be Field Verified Outlet to respective Valve

Chiller-3 To Be Field Verified Outlet to respective Valve

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

Low pressure Steam Boilers (10) To Be Field Verified Outlet to respective Valves

Electrical AHU-6 Main Breaker Supply to Unit

Electrical MAU-1 Main Breaker Supply to Unit

3.0 OBJECTIVE

The intent of this Installation Qualification (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 specified in system manuals, contractors’

submittals, original purchase orders or approved equivalents. These major components
will be verified during execution of this protocol.

 All critical instruments are calibrated and placed within the calibration program
as defined in MF/SOP/178.

 Operation manuals for the system or equipment are identified and available.

 Required spare parts are identified

 System or equipment maintenance requirements are clearly defined and
documented and are placed in the Preventative Maintenance Program as defined in
MF/SOP/179.

 System or equipment cleaning procedures are established and current.

 Lubricants will be identified and evaluated for acceptability during execution of

this protocol.

 As-built drawings reflect 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 certificates 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 qualified 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 Qualification 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 final 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 finished 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 final 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 qualified 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 final 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 specified 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 final 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 Efficiency 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 Qualification

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 specifications and accept/reject criteria that are necessary for making a
decision to accept or reject the system and/or component being qualified.

Summary of Results

A written summary of the qualification policies, procedures, and results that may
include graphs and tables to support conclusions and final acceptance. Also included in
this summary would be documentation of deviations, their investigation, and final
corrective action implemented to provide final 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 Identification 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 Identification/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 certificates 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 specific 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 clarification.

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 Qualification 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 reflecting conclusions for all verifications 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 specified data available at the time of protocol generation should be entered on
each worksheet prior to approval of the protocol. The source of each specified value
entered should be referenced in the comment section of each IQ worksheet. All specified
data that cannot be determined at the time of protocol generation will be recorded as
“Not specified” and the actual value from field verification will be recorded. In the event
a specified cannot be field verified 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 specifications 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:

Classification of Air Cleanliness, First Edition, 1999-05-01.

13.2 ISO-14644-2, Cleanrooms and Associated Controlled Environments, Part 2:

Specifications 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 clarification. Include in
applicable section of summary package. NOTE: Make copies of this worksheet as
necessary.
Completed
Date:
by:
Reviewed by: Date:

QA Approval: Date:
ATTACHMENT #1 – Personnel Identification 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 Identification/Calibration

Document test equipment not installed on the equipment/system being qualified that
are required for execution of this protocol. NOTE: Make copies of this
attachment as necessary.
 Test Equipment Calibration

Last Cal Cal Due Initials

Description Model # Serial # Tag #
Date Date Date

Criteria Met? Initials

Acceptance Criteria
(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 certification(s) for the test equipment

used is attached.

Comments:
Completed
Date:
by:
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.

Current and
Document Effective
Title Documented? Initial/Date
# Date
(Yes/No)
Completed
Date:
by:
Reviewed by: Date:

QA Approval: Date:
ATTACHMENT 4 – Equipment / Component Verification

(one per each main component including instrumentation/Controls)

Description AIR HANDLING UNIT AHU-6

Specified1 Actual Initial/Date

Type A-Series

Mezzanine above Room

Location
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 specified values.

Justifications are provided for actual values that cannot be field

verified.

1
Specified values taken from Dwg # H-04-rev 2, PO # 30563-05, York
Comments
International I/O/M Manual, 100.09-nom1.

Completed
Date:
by:
Reviewed by: Date:
QA Approval: Date:
ATTACHMENT 5 – Utilities Verification

Document Hot Water requirements for the applicable equipment/system undergoing

IQ. Also document specific connections to the facility steam supply. List sources for any
specified information recorded on this page in comments. All information recorded as
actual is from field verification unless recorded as otherwise in comments. NOTE:
Actual information, such as pressure, should be measured where possible.

Description /
Type ( X ) Plant ( ) Clean
Purpose

Item Specified1 Actual Initial/Date

Boiler (7) HydroTherm-

Source
MultiTemp

Regulated Pressure 18 PSI

Temp 173 °F

Method of Joining To be field verified

Criteria Met? Initial/

Acceptance Criteria
(Yes/No/NA) Date

Actual values conform to specified values.

Justifications are provided for actual values that cannot be field

verified.

Dielectric Unions are present between piping of dissimilar metals.

Comments
Completed
Date:
by:
Reviewed by: Date:

QA Approval: Date:
ATTACHMENT 6 – Support Documentation - Equipment/System
Specifications

Document associated equipment/system specifications including, manufacturing

specifications, 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 specifications including

computer system validation plan, process description (user requirements), functional
requirements, design specification, software description and change control history.

Type Title/Description Doc. # Location Initial/Date

 Criteria Met? Initial/
Acceptance Criteria
(Yes/No/NA) Date

Copies of the manufacturing specifications for the

equipment/system are attached.

Installed conditions have been verified to reflect functional

specifications.

Equipment/system logbook established.

Filter specifications and manufacturing validation guides are

available.

HEPA filter specifications are available.

Computer related systems have specifications available.

Comments
Completed
Date:
by:
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.

Initials
Description:
Date

Criteria Met? Initials

Acceptance Criteria
(Yes/No/NA) Date

The submittals have been verified to

accurately describe and document the system
being qualified.

Copies of the approved submittals for the

system and components are attached.

Comments

Completed
Date:
by:
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.

Purchase Order Initials

Description
Number Date

Air Handler AHU-6 30563-05

Variable Air Volume Box 30563-12

Heating/Cooling Coils 30563-05

Exhaust Fans 30563-12

Humidifier H-1 30563-07

Criteria Met? Initials

Acceptance Criteria
(Yes/No/NA) Date

The system being qualified conforms to the PO

requirements.

Copies of the purchase orders for the system and system

components are attached.

Comments

Completed
Date:
by:
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

Criteria Met?
Acceptance Criteria Initials/Date
(Yes/No/NA)

The manufacturers equipment manuals are described

above and the location of each manual is documented.

Comments
Completed
Date:
by:
Reviewed by: Date:

QA Approval: Date:
ATTACHMENT 10 – Support Documentation - Equipment/System Drawings

Document associated process flow 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 sufficient to characterize the equipment/system. Verify that components
are physically labeled in accordance with drawings. Highlight the verified portions of
the drawings and redline changes as necessary. All drawings must be verified, signed,
and dated. Submit any redlined drawings to the Document Control Group for revision.
Include copies of the highlighted, verified drawings, redlined copies, and applicable
Document Control Forms with this summary package. NOTE: Make copies of this
attachment as necessary.

NOTE: Controller diagrams and wiring diagrams will be documented on separate

attachments.

Drawing # Title Rev. Rev. Date Initial/Date

Acceptance Criteria Criteria Met? Initial/

 (Yes/No/NA) Date

Drawing list includes associated equipment, facility, and utility

drawings.

Drawings, with redlines if applicable, are sufficient 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 verified drawings and redline copies are included with

this summary package.

Drawings have been verified, 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 files.

Comments
Completed
Date:
by:
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

Criteria Met? Initial/

Acceptance Criteria
(Yes/No/NA) Date
List above includes operation, maintenance, cleaning, and
sanitization procedures as applicable that are approved and
current.

Comments

Completed
Date:
by:
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

 Criteria Met? Initial/
Acceptance Criteria
(Yes/No/NA) Date

All calibration procedures associated with the critical instruments

on the equipment/system undergoing are approved and current.

Comments

Completed
Date:
by:
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 verification, process instrument materials of construction

verification, and digital sensors and controlling/monitoring switches list will be
documented on separate attachments.

Associated
Component Associated
Cal Rev. Cal Last Cal Initial/
Asset # and Cal Rev.
Procedure Date Frequency Date Date
Description Procedure #
Title

Criteria Met? Initial/

Acceptance Criteria
(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
Date:
by:
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/ Initial/
Spare Parts List Location
System Name Date

AHU-6 Form 100.09-MOM1 York International O/M Manual

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

 Criteria Met? Initial/
Acceptance Criteria
(Yes/No/NA) Date

Locations of manufacturer’s recommended spare parts lists are

documented.

Comments

Completed
Date:
by:
Reviewed by: Date:

QA Approval: Date:
ATTACHMENT 15 – Maintenance - Lubricant Verification

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 Acceptable? Initial/

Purpose
and Manufacturer (Yes/No) Date
 Criteria Met? Initial/
Acceptance Criteria
(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
Date:
by:
Reviewed by: Date:

QA Approval: Date:
Download the accompanying presentation, "Effective Qualification of Critical Utilities,"
presented at IVT's Validation and cGMP Week Puerto Rico, San Juan, Puerto Rico, July
2011.
SHARE ON FACEBOOKFACEBOOKSHARE ON TWITTERTWITTERSHARE ON PINTEREST_SHAREPINTERESTSHARE ON
EMAILEMAILMORE SHARING SERVICESADD THIS
PRINTER-FRIENDLY VERSION
Tags:
GMP - Qualification, Facilities Utlities and Equipment

Miguel Montalvo
Miguel Montalvo, B.S. Chem. Eng., MBA, President, Expert Validation Consulting, has over
twenty-seven years of professional/management experience in positions of increasing
responsibility in the areas of Quality,...
View Author Bio

Comments (1)
Mr. anuj kumar Singh May 9, 2014 11:41 pm PDTReply
Nice Documents

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