INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL -

IOQ EQUIPMENT
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Table of Contents
1 APPROVAL PAGE 3
2 PURPOSE 4
3 SCOPE 4
4 OUT OF SCOPE STATEMENT: 5
5 PROJECT BACKGROUND: IMPACT ANALYSIS 6
6 EQUIPMENT / SYSTEM / PROCESS DESCRIPTION 7
7 EQUIPMENT/ SYSTEM COMPATIBILITY AND EQUIVALENCY DESCRIPTION 8
8 MINIMUM SYSTEM REQUIREMENTS 8
9 REFERENCES 9
10 DEFINITIONS AND SYMBOLS/ ACRONYMS 10
11 QUALIFICATION STRATEGY 14
12 ROLES AND RESPONSIBILITIES 15
13 GENERAL EXECUTION PROCEDURE 16
14 INDIVIDUAL TEST PROTOCOL (ITPs) CHECKLIST 19
15 PRE-REQUISITES 22
ITP-001 - Equipment Identification / Purchase Order Verification 23
ITP-002 - Environmental, Health, and Safety (EHS) Release Verification 24
16 INSTALLATION TESTING INITITATION 25
ITP-003 - Major Mechanical Components and Ancillary Equipment 26
ITP-004 - Equipment Location Verification 27
ITP-005 - Engineering Documentation Review and Verification 28
ITP-006 - Drawings Walk Down/ Mark-up 29
ITP-007 - Electrical Power Supply Utility Verification 30
ITP-008 - Compressed Air Supply Utility Verification 31
ITP-009 - Equipment / System Instrumentation and Calibration Verification 32

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IOQ EQUIPMENT
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ITP-010 - Preventive Maintenance 33

ITP-011 - Manufacturing Materials and Contact Surfaces Verification 34
ITP-012 - Filters Verification 35
ITP-013 - Spare Parts List Verification 36
ITP-014 - Product Contact Material Verification 37
ITP-015 - Environmental Conditions Verification 38
ITP-016 - Controlled Procedures, Work Instructions, Forms, and Specifications Verification 39
17 INSTALLATION TESTS COMPLETION CHECKLIST & DISPOSITION 40
18 OPERATIONAL QUALIFICATION - FUNCTIONAL TESTING INITIATION 41
ITP-017 - Power On / Off 42
ITP-018 - Alarms and Interlocks Verification 43
ITP-019 - Operator Interface / Panel Functional Verification 44
ITP-020 - Interference Verification 45
ITP-021- System Response to a Power Failure or Process Interruption 46
19 GENERAL SUPPORTING INFORMATION 47
ITP-022 - Training Verification 48
ITP-023 - Measuring and Test Instruments / Equipment Calibration 49
ITP 024 - Backup Media Verification 50
20 OPERATIONAL QUALIFICATION COMPLETION CHECKLIST & DISPOSITION 50
21 PROTOCOL ATTACHMENTS AND APPENDIXES 51
APPENDIX 1: PROTOCOL SIGNATURE IDENTIFICATION SHEET 52
APPENDIX 2: PROTOCOL DISCREPANCY/ DEVIATION LOG 53
APPENDIX 3: DISCREPANCY / DEVIATION REPORT FORM 54
APPENDIX 4: PROTOCOL ATTACHMENT LOG 55

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IOQ EQUIPMENT
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1. APPROVAL PAGE

Your signature indicates that you have reviewed this document and agree that it accurately and completely
represents the system and the necessary validation activities. You also agree that this document complies
with company validation procedures and instructions.
Prepared by: Author
Printed Name Signature Date

Approved by: Quality Assurance

Printed Name Signature Date

HISTORY OF CHANGE
History of Change Change Control Section Author Reason for Revision
Version Number Number and Owner (Description of Change)

LEGAL DISCLAIMER – TERMS AND CONDITIONS OF USE

IMPORTANT: The information in this document is of a general nature, and should not be relied upon as
individual professional advice. If necessary, legal advice should be obtained from a legal practitioner with
expertise in the field of quality management law. Although every effort has been made to ensure that the
information in this document is complete, current and accurate, the CIQA Quality Management Committee,
any agent, author or contributor accepts no responsibility for any loss, damage or personal injury that may
result from the use of any material which is not complete, current and accurate if used by other company nor
purposes. Users should always verify historical material by making and relying upon their separate inquiries
before making any important decisions or taking any action based on this information.
FURTHER ASSISTANCE
CIQA Quality Specialists are available to give more advice and assistance on all quality management
matters. We can be contacted via our website at www.ciqa.net or email [email protected].
ADDITIONAL INFORMATION
More document templates, information and guides can be found at the following websites:
www.ciqa.net/store or calling at 787-487-9235.

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IOQ EQUIPMENT
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2. PURPOSE

This installation and operational qualification (IOQ) protocol aims to bring the documented evidence that the
equipment described in Table 1 have been installed, configured appropriately, and function as expected,
according to company requirements specifications, intended use, and applicable manufacturer's
recommendations.

Equipment System Name Manufacturer Model / Serial Location

& Description Asset ID number
Hardware
Name

Machine
Name

TABLE 1 - SYSTEM DESCRIPTION SUMMARY

This document will identify the instructions to verify that the equipment have been installed and operates in
its final environment as per manufacturer’s specifications and corporate’s requirements.

3. SCOPE

The scope of this protocol covers the industrial machinery / non-computerized system equipment described
in table 1 and includes all related devices and ancillary equipment that support it access and utilization. In
addition, the scope includes all related test cases, documentation, references, specifications, and acceptance
criteria used to establish the required evidence to demonstrate that it is installed and performs in accordance
with supplier’s recommendations, cGMP guidelines and local documentation requirements.

Scope Statement

The scope of this protocol includes the installation and operation testing of the equipment and
machinery in the following conditions and environment.

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4. OUT OF SCOPE STATEMENT:

Otherwise, established in the protocol scope, this protocol is not intended to cover indirect equipment or
supporting systems as: utilities, company network, cloud system, virtual network operating systems,
company data center, its servers and any other supporting devices or software applications.

Out of Scope Statement

Requirements related to CSV Computer system validation and its software are considered out of the
scope of this industrial equipment and machinery installation and operational qualification protocol,
since separate and specific CSV protocols could be used for that purpose.

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5. PROJECT BACKGROUND: IMPACT ANALYSIS

This section describes the reason that triggers the installation and operational testing of the equipment in
the assigned area and its intended use. Perform an engineering analysis describing:
• The frequency and how much time or how long, this equipment shall be used per day.
• The amount of utilities consumption that it requires to operate during the expected usage time
considering all other equipment already installed that share the same utilities capacity.
• The impact and effect that this installation may cause in the environmental control room conditions,
as: air flow pattern, room temperature, % relative humidity, particle count, etc.
Also, this section explains the rational to install and use the equipment in this area in terms of the layout
and workflow of materials and people. Document the evaluation in the following table 2.
TABLE 2. IMPACT ANALYSIS - ENGINEERING EVALUATION BEFORE THE INSTALLATION-
a) Reason to install and use the equipment in this area
b) Is enough space in this area to install the equipment and  Yes,  No,  N/A
the operators and materials to move and work?
c) Intended use of the equipment
d) Expected frequency of use [e.g hr/day, etc]
e) Is enough capacity in the utilities to install the equipment:
Electric Consumption [e.g. BTU, Amps/hr, etc]  Yes,  No,  N/A
Compressed Air Consumption [e.g. cu.ft/minute, etc]  Yes,  No,  N/A
Water Consumption [e.g. liters/minute, etc.]  Yes,  No,  N/A
Other Consumptions, explain:  Yes,  No,  N/A
f) Potential Impact in the layout and workflow
Materials (Describe the type and amount of material
necessary to operate the equipment)
People (Describe the positions and required number
of persons operating the equipment)
g) Environmental Room Classification  ISO Class 6,  ISO Class 7,
 ISO Class 8,  ISO Class 9,  Unclassified
h) Potential Impact in the environmental control room
conditions
Air flow pattern, Room Air Changes  Yes,  No,  N/A
Room temperature, % Relative humidity,  Yes,  No,  N/A
Viable particle count  Yes,  No,  N/A
Non-viable particle counts  Yes,  No,  N/A
Others:  Yes,  No,  N/A

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6. EQUIPMENT / SYSTEM / PROCESS DESCRIPTION

SYSTEM DESCRIPTION

This section describes the specific hardware and software necessary to operate the computer system
application for its intended use in the company. It includes a diagram of the infrastructure and supporting
devices to use the computerized system, as applicable.

System Description

System Diagram or Figure

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7. EQUIPMENT/ SYSTEM COMPATIBILITY AND EQUIVALENCY DESCRIPTION

The equipment to be installed and accessed by the authorized and trained operator(s) may be compatible
and equivalent to other devices or equipment in site. Since additional equipment, devices or workstations
will perform equivalent tasks, then, these similarities and compatibilities shall be documented as objective
evidence provided. Describe how many equipment of similar model shall be qualified under this protocol.

Equipment Brand or Model Amount of System Compatibility and Equivalency

Description manufacturer equipment Rational

8. MINIMUM SYSTEM REQUIREMENTS

The equipment control system shall be described in this section with the minimum requirements to be
installed, accessed and operated individually or concurrently by authorized and trained operator(s).

System Description Minimum requirements

Control System Platform

Firmware / Operating System
RAM GB
Free space on the hard drive GB
Screen resolution
Human Interphase
Other:
Other:
Other:
Other:
Other:

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9. REFERENCES

Qualification / Validation Procedures, Specifications and Related Documents

Revision
Document Number Document Title
Number

Operating Procedures, Instructions and Forms

Revision
Document Number Document Title
Number

Previous Qualification / Validation Related Documents

Revision /
Document Number Version Document Title
Number

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10. DEFINITIONS AND SYMBOLS/ ACRONYMS

This section presents definitions of terms the symbols / acronyms specific to this document.

Term Definition
Auxiliary or supporting equipment attached or connected to primary equipment. Its
Ancillary purpose is to support the operation of the primary equipment, although the primary
equipment can be operated without it.
Change
Management Change Management System, electronic system to request and approve changes.
System (CMS)
Achieving and maintaining compliance with applicable GxP regulations and fitness for
Computer System intended use by adoption of principles, approaches, and lifecycle activities within the
Validation framework of validation plans and reports; and the application of appropriate
operational controls throughout the life of the system.
Incongruity encountered under the scope of a protocol. Discrepancies should be
addressed with their resolution documented and approved by representatives
Discrepancy involved in the approval of the qualification/validation protocol. Each discrepancy
should be addressed, evaluated and a conclusion drawn as to acceptance or rejection
of the results
Includes equipment, machines and tools with embedded software based controllers
Equipment
used within the quality system to make a quality decision, unless otherwise verified.
A pre-approved form intended to be used to provide instructions for testing of
Equipment equipment when repair or maintenance that could affect the functionality of the
Performance equipment is required. The intention of the EPR is to verify and document that the
Report (EPR) repairs performed to the equipment does not impact the validated state of the
equipment

Gage R&R Gage Repeatability & Reproducibility (R & R) Study

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