INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL - IOQ .

INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL IOQ EQUIPMENTDocument Number:RevisionSupersedes IDPage: 1 of 56Table of Contents1APPROVAL PAGE32PURPOSE43SCOPE44OUT OF SCOPE STATEMENT:55PROJECT BACKGROUND: IMPACT ANALYSIS66EQUIPMENT / SYSTEM / PROCESS DESCRIPTION77EQUIPMENT/ SYSTEM COMPATIBILITY AND EQUIVALENCY DESCRIPTION88MINIMUM SYSTEM REQUIREMENTS89REFERENCES910 DEFINITIONS AND SYMBOLS/ ACRONYMS1011 QUALIFICATION STRATEGY1412 ROLES AND RESPONSIBILITIES1513 GENERAL EXECUTION PROCEDURE1614 INDIVIDUAL TEST PROTOCOL (ITPs) CHECKLIST1915 PRE-REQUISITES22ITP-001 - Equipment Identification / Purchase Order Verification23ITP-002 - Environmental, Health, and Safety (EHS) Release Verification2416 INSTALLATION TESTING INITITATION25ITP-003 - Major Mechanical Components and Ancillary Equipment26ITP-004 - Equipment Location Verification27ITP-005 - Engineering Documentation Review and Verification28ITP-006 - Drawings Walk Down/ Mark-up29ITP-007 - Electrical Power Supply Utility Verification30ITP-008 - Compressed Air Supply Utility Verification31ITP-009 - Equipment / System Instrumentation and Calibration Verification32Confidential Document - CIQA Copyrights – Do not copy without authorizationThis document is property of CIQA and the copyrights laws apply, to limit its distribution, publication or verbal disclosure to anyone, without theCIQA consent. Its distribution is prohibited by any means without the written permission of CIQA Inc.

INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL IOQ EQUIPMENTDocument Number:RevisionSupersedes IDPage: 2 of 56ITP-010 - Preventive Maintenance33ITP-011 - Manufacturing Materials and Contact Surfaces Verification34ITP-012 - Filters Verification35ITP-013 - Spare Parts List Verification36ITP-014 - Product Contact Material Verification37ITP-015 - Environmental Conditions Verification38ITP-016 - Controlled Procedures, Work Instructions, Forms, and Specifications Verification3917 INSTALLATION TESTS COMPLETION CHECKLIST & DISPOSITION4018 OPERATIONAL QUALIFICATION - FUNCTIONAL TESTING INITIATION41ITP-017 - Power On / Off42ITP-018 - Alarms and Interlocks Verification43ITP-019 - Operator Interface / Panel Functional Verification44ITP-020 - Interference Verification45ITP-021- System Response to a Power Failure or Process Interruption4619 GENERAL SUPPORTING INFORMATION47ITP-022 - Training Verification48ITP-023 - Measuring and Test Instruments / Equipment Calibration49ITP 024 - Backup Media Verification5020 OPERATIONAL QUALIFICATION COMPLETION CHECKLIST & DISPOSITION5021 PROTOCOL ATTACHMENTS AND APPENDIXES51APPENDIX 1: PROTOCOL SIGNATURE IDENTIFICATION SHEET52APPENDIX 2: PROTOCOL DISCREPANCY/ DEVIATION LOG53APPENDIX 3: DISCREPANCY / DEVIATION REPORT FORM54APPENDIX 4: PROTOCOL ATTACHMENT LOG55Confidential Document - CIQA Copyrights – Do not copy without authorizationThis document is property of CIQA and the copyrights laws apply, to limit its distribution, publication or verbal disclosure to anyone, without theCIQA consent. Its distribution is prohibited by any means without the written permission of CIQA Inc.

INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL IOQ EQUIPMENTDocument Number:RevisionSupersedes IDPage: 3 of 561. APPROVAL PAGEYour signature indicates that you have reviewed this document and agree that it accurately and completelyrepresents the system and the necessary validation activities. You also agree that this document complieswith company validation procedures and instructions.Prepared by: AuthorPrinted NameSignatureDateApproved by: Quality AssurancePrinted NameSignatureDateHISTORY OF CHANGEHistory of ChangeVersion NumberChange ControlNumberSectionAuthorand OwnerReason for Revision(Description of Change)LEGAL DISCLAIMER – TERMS AND CONDITIONS OF USEIMPORTANT: The information in this document is of a general nature, and should not be relied upon asindividual professional advice. If necessary, legal advice should be obtained from a legal practitioner withexpertise in the field of quality management law. Although every effort has been made to ensure that theinformation 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 mayresult from the use of any material which is not complete, current and accurate if used by other company norpurposes. Users should always verify historical material by making and relying upon their separate inquiriesbefore making any important decisions or taking any action based on this information.FURTHER ASSISTANCECIQA Quality Specialists are available to give more advice and assistance on all quality managementmatters. We can be contacted via our website at www.ciqa.net or email sales@ciqa.net.ADDITIONAL INFORMATIONMore document templates, information and guides can be found at the following websites:www.ciqa.net/store or calling at 787-487-9235.Confidential Document - CIQA Copyrights – Do not copy without authorizationThis document is property of CIQA and the copyrights laws apply, to limit its distribution, publication or verbal disclosure to anyone, without theCIQA consent. Its distribution is prohibited by any means without the written permission of CIQA Inc.

INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL IOQ EQUIPMENTDocument Number:RevisionSupersedes IDPage: 4 of 562. PURPOSEThis installation and operational qualification (IOQ) protocol aims to bring the documented evidence that theequipment described in Table 1 have been installed, configured appropriately, and function as expected,according to company requirements specifications, intended use, and applicable manufacturer'srecommendations.Equipment System Name& DescriptionHardwareNameManufacturerModelAsset ID/SerialnumberLocationMachineNameTABLE 1 - SYSTEM DESCRIPTION SUMMARYThis document will identify the instructions to verify that the equipment have been installed and operates inits final environment as per manufacturer’s specifications and corporate’s requirements.3. SCOPEThe scope of this protocol covers the industrial machinery / non-computerized system equipment describedin table 1 and includes all related devices and ancillary equipment that support it access and utilization. Inaddition, the scope includes all related test cases, documentation, references, specifications, and acceptancecriteria used to establish the required evidence to demonstrate that it is installed and performs in accordancewith supplier’s recommendations, cGMP guidelines and local documentation requirements.Scope StatementThe scope of this protocol includes the installation and operation testing of the equipment andmachinery in the following conditions and environment.Confidential Document - CIQA Copyrights – Do not copy without authorizationThis document is property of CIQA and the copyrights laws apply, to limit its distribution, publication or verbal disclosure to anyone, without theCIQA consent. Its distribution is prohibited by any means without the written permission of CIQA Inc.

INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL IOQ EQUIPMENTDocument Number:RevisionSupersedes IDPage: 5 of 564. OUT OF SCOPE STATEMENT:Otherwise, established in the protocol scope, this protocol is not intended to cover indirect equipment orsupporting 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 StatementRequirements related to CSV Computer system validation and its software are considered out of thescope of this industrial equipment and machinery installation and operational qualification protocol,since separate and specific CSV protocols could be used for that purpose.Confidential Document - CIQA Copyrights – Do not copy without authorizationThis document is property of CIQA and the copyrights laws apply, to limit its distribution, publication or verbal disclosure to anyone, without theCIQA consent. Its distribution is prohibited by any means without the written permission of CIQA Inc.

INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL IOQ EQUIPMENTDocument Number:RevisionSupersedes IDPage: 6 of 565. PROJECT BACKGROUND: IMPACT ANALYSISThis section describes the reason that triggers the installation and operational testing of the equipment inthe 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 timeconsidering 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 layoutand workflow of materials and people. Document the evaluation in the following table 2.TABLE 2. IMPACT ANALYSIS - ENGINEERING EVALUATION BEFORE THE INSTALLATIONa) Reason to install and use the equipment in this areab) Is enough space in this area to install the equipment and Yes, No, N/Athe operators and materials to move and work?c) Intended use of the equipmentd) Expected frequency of use [e.g hr/day, etc]e) Is enough capacity in the utilities to install the equipment: Yes, No, N/AElectric Consumption [e.g. BTU, Amps/hr, etc]Compressed Air Consumption [e.g. cu.ft/minute, etc] Yes, No, N/A Yes, No, N/AWater Consumption [e.g. liters/minute, etc.] Yes, No, N/AOther Consumptions, explain:f) Potential Impact in the layout and workflowMaterials (Describe the type and amount of materialnecessary to operate the equipment)People (Describe the positions and required numberof persons operating the equipment) ISO Class 6, ISO Class 7,g) Environmental Room Classification ISO Class 8, ISO Class 9, Unclassifiedh) Potential Impact in the environmental control roomconditions Yes, No, N/AAir flow pattern, Room Air Changes Yes, No, N/ARoom temperature, % Relative humidity, Yes, No, N/AViable particle count Yes, No, N/ANon-viable particle counts Yes, No, N/AOthers:Confidential Document - CIQA Copyrights – Do not copy without authorizationThis document is property of CIQA and the copyrights laws apply, to limit its distribution, publication or verbal disclosure to anyone, without theCIQA consent. Its distribution is prohibited by any means without the written permission of CIQA Inc.

INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL IOQ EQUIPMENTDocument Number:RevisionSupersedes IDPage: 7 of 566. EQUIPMENT / SYSTEM / PROCESS DESCRIPTIONSYSTEM DESCRIPTIONThis section describes the specific hardware and software necessary to operate the computer systemapplication for its intended use in the company. It includes a diagram of the infrastructure and supportingdevices to use the computerized system, as applicable.System DescriptionSystem Diagram or FigureConfidential Document - CIQA Copyrights – Do not copy without authorizationThis document is property of CIQA and the copyrights laws apply, to limit its distribution, publication or verbal disclosure to anyone, without theCIQA consent. Its distribution is prohibited by any means without the written permission of CIQA Inc.