Installation / Operational Qualification Protocol For The PHSC 338 Validation Project Protocol Number: IOQ0001.00

Campbell University
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INSTALLATION / OPERATIONAL QUALIFICATION

PROTOCOL FOR THE
ENTER EQUIPMENT NAME HERE
PHSC 338 VALIDATION PROJECT
Protocol Number: IOQ0001.00
Campbell University
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PROTOCOL PRE-APPROVAL
Completion of the following signature blocks signifies the approver has read, understands, and agrees with the content of this document.
Name
Job Title or Role
Signature
Date
(mm/dd/yy)
The Lead Author is signing to confirm that this document has been prepared in accordance with GSK standards
Author:
The Validation Representative is signing to confirm that the acceptance criteria, test methods and technical content is correct.
Approved by:
Validation Representative:
The Quality Assurance Representative is signing to confirm that the acceptance criteria, test methods and technical content is correct.
Approved by:
Quality Assurance
Representative:
PROTOCOL POST-APPROVAL
The system Installation and Operational Qualification has been reviewed; no items are outstanding. The system Installation and Operational
Qualification is unconditionally accepted. Signoff indicates completion of the protocol only, not acceptance of the validation without a summary
of results.
Name
Job Title or Role
Signature
Date
(mm/dd/yy)
The Validation Representative is signing to confirm acceptance of results and supporting data. All outstanding items have been completed.
Approved by:
Validation Representative
The Quality Assurance Representative is signing to confirm acceptance of results and supporting data. All outstanding items have been
completed.
Approved by:
Quality Assurance
Representative
Campbell University
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CONTENT
Section Title
Section
Reference Documents
Version History
Codes, Definitions and Abbreviations
Purpose
System Description
System Boundaries / Scope
Discrepancies List
Verification Documentation
Acceptance Criteria Summary
Test Sheets
12
Appendices
13
Discrepancy Report
13.1
IOQ Amendment Form
13.2
List of Attachments
13.3
Campbell University
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REFERENCE DOCUMENTS
Ref.
1
2
3
Document No.
XXX-XXX
Document Title
Reference documents go here Specifications, etc.
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VERSION HISTORY
Date
(mm/dd/yy)
XX/XX/XX
Version
0
Revised By
Author Name
Reason for Revision

Initial Issue
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CODES, DEFINITIONS AND ABBREVIATIONS

General definitions and abbreviations used throughout this document include, but are not limited to, the
following:
(Add as applicable.)
cc
cGMP
DA
EDR
=
=
=
=
Cubic Centimeter
Current Good Manufacturing Practices
Device Assessment
Enhanced Design Review Protocol
FAT
FDA
HMI
IOQ
=
=
=
=
Factory Acceptance Test

Food and Drug Administration
Human Machine Interface
ml
Milliliter
mm
Millimeter
NEC
National Electrical Code
OIT
Operator Interface Terminal
OEM
Original Equipment Manufacturer
OSHA
Occupational Safety and Health Act
PLC
Programmable Logic Controller
PM
Preventive Maintenance
QA
Quality Assurance
SOP
URS
VMP
=
=
=
Standard Operating Procedure

User Requirement Specification
Validation Master Plan
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PURPOSE
The purpose of this protocol is to provide documented evidence that (This should be a general
statement for summarizing the intent of the document. Why was this protocol written?)
5.
SYSTEM DESCRIPTION
(This should be the system description from your specification sheet. The system description
provides a description of the equipment, location, intended use, major components, operational
characteristics and other pertinent information. This section may also reference the location of a
detailed description (i.e. the original protocol, or applicable specification).)
6.
SYSTEM BOUNDARIES / SCOPE

The scope section details the nature, scope, of the testing to be performed. Are you doing IQ, OQ,
PQ, or all qualifications? Why, new equipment or requalification?)
a. Installation Qualification (Give a description of all key aspects of the installation, including
verification to design intentions i.e. drawing verification, calibrations needed etc. To verify that
you have got what you ordered and that it is installed per design documents.)
b. Operational Qualification (Give a description of all key aspects of the qualifications,
including process design intentions, reasons, i.e. verify temperature ranges and other critical
parameters. To verify that the equipment operates as expected per design.)
Campbell University
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DISCREPANCIES LIST
Record each of the discrepancies raised during the completion of the execution of the protocol
and the date that the discrepancy was resolved. (Reference Section 13.1: Discrepancy Report)
Discrepancy
Ref.
Test Page
No.
Discrepancy Description
Date Resolved
(mm/dd/yy)
Initial and Date
Campbell University
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Page _____ of _____1

Title:
Documentation - Calibration Verification Record
Objective:
To provide documented evidence that all instrumentation classified as critical within the EQUIPMENT NAME has been calibrated.
Method:
Verify that all instruments classified as critical are calibrated. List and review calibration certification available for each of the critical instruments
and document the calibration certificate reference, calibration date and calibration due date as applicable.
Acceptance Criteria:
A valid calibration certificate exists for all instrumentation classified as critical. A copy of the calibration certificates have been attached to this
protocol.
Inst Ref
Instrument Description
Cert Ref
Calibration
Date
Calibration
Due Date
Acceptance
Criteria Met?
(Yes/No)
Discrepanc
y/
Comment
Make additional copies as necessary.
Comments:
Supporting Data:
Initial / Date:
Acceptance Criteria Met (Yes/No):
Initial / Date:
Reviewed by:
Date:
Signature:
Initial / Date
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Equipment List Verification
Objective:
The purpose of this verification is to provide a comprehensive list of key system components.
Method:
Collect and review copies of the purchase orders, system drawings, installation specifications, functional specifications, and other
related information that supports the installation of the equipment, where available.
Record and complete an equipment list of key system components based on information from purchase orders and equipment
specifications. Verify that the items have been delivered and installed as per manufacturer's specification.
The critical devices have been correctly installed to the manufactures recommendations and correctly tagged.
Device Ref
Model / Serial
Number
Actual Model
Actual Serial
No
Correctly
Installed?
(Yes/No)
Correctly
Tagged?
(Yes/No)
Acceptance
Criteria
Met?
(Yes/No)
Discrepancy
/ Comment
Comments:
Supporting Data:
Initial / Date:
Initial / Date:
Reviewed by:
Date:
Signature:
Initial/Date
Campbell University
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Title:
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Engineering & Technical Documentation Verification
Objective:
To provide a comprehensive list of the engineering documentation and manuals for the equipment as defined in the system description
of this protocol.
Method:
Collect and review copies of the installation specifications, functional specifications, vendor manuals, purchase orders, spare parts lists and
other related information that supports the installation and operational requirements for the equipment, where available.
Prepare a list of all applicable specifications, purchase orders, equipment manuals and spare parts lists. Review these documents for
conformance to the system "as-built". Include copies or document the file location of the latest revisions within the Equipment Project File.
All pertinent manuals and technical documentation relating to the system must be available and reflect the installed system.
Document
Number
Document Type / Title
Expected
Rev.
Revision
No. / Date
Effective
Date:
Location:
Acceptance
Criteria
Met?
(Yes/No)
Discrepanc
y/
Comment
Comments:
Supporting Data:
Initial / Date:
Initial / Date:
Reviewed by:
Date:
Signature:
Initial/Date
Campbell University
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Title:
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Drawing Verification
Objective:
To verify that appropriate drawings for this equipment exist, are accurate, and reflect the as-built field installation.
Method:
Collect the current drawings that pertain to the system and prepare a list of all drawings and P&ID's associated with the system. Attach
field verified copies of the latest revisions within the validation protocol.
All drawings must reflect the as-built condition or must have been red-lined where necessary. Each drawing must include the
signature of the person who field-checked the drawing for accuracy, and the review signature of the technical representative. Copies of
all drawings are to be attached (where applicable) and all red-lined drawings must be attached.
Document Type / Title
Drawing Number
Revision
No. / Date
Signature
(Yes/No)
Effective
Date:
Location:
Acceptance
Criteria
Met?
(Yes/No)
Discrepanc
y/
Initial/Date
Comment
Comments:
Supporting Data:
Initial / Date:
Initial / Date:
Reviewed by:
Date:
Signature:
Campbell University
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Title:
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Spare Parts Verification
Objective:
To provide a comprehensive list of spare parts, which are installed in this system
Method:
Collect and review copies of the purchase orders, system drawings, installation specifications, functional specifications, and other related
information that supports the installation of the equipment, where available.
Record and complete a list of spare parts on this system. Verify that the spare parts list has been delivered with manufacturer's documentation.
Change Parts must be identified and described.
Componen
t
Manufacturer
Description
Expected
Results
Actual Results
Acceptance
Criteria Met?
(Yes/No)
Discrepancy /
Comment
Comments:
Supporting Data:
Initial / Date:
Initial / Date:
Reviewed by:
Date:
Signature:
Initial/Date
Campbell University
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Title:
Document Type
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Materials in Product Contact
Objective:
To provide a comprehensive list of materials in product contact.
Method:
Collect, review, and complete a list of the materials of construction of the system components in product contact based on information from
purchase orders and equipment specifications. Using field verification or equipment documentation, record the method of documentation used
and attach any supporting documentation. Verify that the materials conform to specifications and are suitable for use.
Materials of construction must conform to specifications and be suitable for intended application.
Component
Title:
Material
Expected Results
Actual Results
Acceptance
Criteria
Met?
(Yes/No)
Discrepancy /
Comment
Utilities Requirements Verification
Objective:
To verify that the supporting utilities for the equipment are connected and supplies services within the specified parameters.
Comments:
Supporting Data:
Initial / Date:
Initial / Date:
Reviewed by:
Date:
Signature:
Initial/Dat
e
Campbell University
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Title:
Document Type
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Utilities Requirements Verification
Method:
Record the as-found condition in the table below. If information is not specified, record the information as baseline information. Verify that the
utilities have been installed or are available as specified. Include description, specifications and available qualification for each item, as
applicable.
Tools:
Calibrated multi-meter, pressure gauge and thermometer
As-Found conditions must conform to specifications. Where specifications are not listed, the as-found conditions are recorded.
Utility
Expected Results
Actual Results
Acceptance
Criteria Met?
(Yes/No)
Discrepancy /
Comment
Comments:
Supporting Data:
Initial / Date:
Initial / Date:
Reviewed by:
Date:
Signature:
Initial/Date
Title:
Procedure Verification
Objective:
To document and verify that the procedures for the equipment are current and applicable.
Method:
Obtain each procedure that is applicable to the equipment (including, but not limited to, operation, preventive maintenance, SOPs, etc.) Attach
any draft or red-lined procedures.
All applicable procedures are listed in the data table. Any changes have been red-lined where necessary. Any draft or red-lined procedure is
attached.
Type
Procedure Title
Title:
Document
Number
Revision
Number
Location
Effective
Date
Acceptance
Criteria Met?
(Yes/No)
Discrepancy /
Comment
Initial/Date
PLC Software and Backup Verification
Objective:
To verify that the installed PLC/software program is adequately documented and that backup versions are available and that their storage
locations are documented.
Method:
Verify that the PLC/software program information is available and can be backed-up accordingly. Verify and document the location of each
electronic media copy.
The programs on the two backup copies are the same as the installed program on the PLC and are properly labeled. The storage location has
been documented.
Item
OIT Model
File Name
Version
Number
Version Date
Location
Acceptance
Criteria Met?
(Yes/No)
Discrepancy /
Comment
Initial/Date
Title:
PLC Software and Backup Verification
OIT Manufacturer
Verify the following items
Can the PCL/Software program be backed up?
If so, verify the backup copy has the same version # and date.
Discrepancies
(Y/N):
Inspected By/Date
Campbell University
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Installation Qualification Acceptance

The purpose of this acceptance is to document that any discrepancies or variations noted during the performance of this
Installation Qualification section have been documented and verify that the equipment is ready for the Operational
Qualification section of this protocol.
Signature of author verifies that all discrepancies have been documented and closed.
Name
Name:
Role
Author
Signature
Date (mm-dd-yy)
Campbell University
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(This section (s) should be used to test functionality of the equipment. For example: dial functionality, toggle switches, on/off
capability, etc. Each test section should have a purpose, method, and a table which provides results for test data (see sample below)
Title:
Operational Testing (SPECIFICATION 1)
Objective:
(Describe objective here. ** EXAMPLE : To verify the vessel can maintain a temperature setpoint of 2-8 degC at low volume.**)
Method:
(give general instructions here. *** EXAMPLE : Calibrated thermocouples will be placed throughout the vessel to verify temperature is
maintained at 2-8 C at low volume.***)
Tools:
(List tools used here).
EXAMPLES:
Kaye Validator 2000 w/ laptop
Wrench
Screwdriver
(The acceptance criteria should be written as such the actual results obtained match the pre-decided expected results. ***
EXAMPLE: Entire vessel maintains temperature range of 208deg for NLT 5 hours at low volume.****)
Comments:
Supporting Data:
Initial / Date:
Initial / Date:
Reviewed
by:
Signature:
Date:
Campbell University
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Test Method
Pre-calibrate thermocouples
2Place thermocouples throughout
vessel as indicated on Thermocouple
Placement Map (Attachment #1)
Fill vessel with 750Liters of water.
Temperature setpoint of the vessel is
set to 5 3 deg C
Expected Results
Thermocouples are
satisfactory calibrated
Thermocouples are
placed in vessel as
specified.
Vessel is filled with
75010 liters of water
Vessel setpoint reads
5 3 deg C
Kaye Validator started and

temperature verification satisfactorily
starts
Kaye Validator is stopped after NLT 5
hours of qualification data.
Qualification run is
started
Review data collected to ensure

temperature is maintained at 2-8 deg
C
Data indicates temp is

maintained at 2-8 C
Qualification run ends

after NLT 5 hours of
data is recorded.
Actual Results
Acceptance
Criteria Met?
(Yes/No)
Discrepancy /
Comment
Vessel volume =
_____ liters
Vessel temp
setpoint =
_____ deg C
Qualification
start time
=________
Qual End time =
______
Run Time
=________
Comments:
Supporting Data:
Initial / Date:
Initial / Date:
Reviewed
by:
Signature:
Date:
Initial/ Date
Campbell University
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Title:
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Objective:
(Describe objective here.)
Method:
(give general instructions here. )
Tools:
Test Method
Expected Results
Actual Results
Acceptance
Criteria Met?
(Yes/No)
Discrepancy /
Comment
Comments:
Supporting Data:
Initial / Date:
Initial / Date:
Reviewed
by:
Signature:
Date:
Initial/ Date
Campbell University
System Title
System No.
Document No.
Title:
Ver
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Document Type
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Page 22 of 30
Objective:
Method:
Tools:
Test Method
Expected Results
Actual Results
Acceptance
Criteria Met?
(Yes/No)
Discrepancy /
Comment
Comments:
Supporting Data:
Initial / Date:
Initial / Date:
Reviewed
by:
Signature:
Date:
Initial/ Date
Campbell University
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Title:
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Objective:
Method:
Tools:
Test Method
Expected Results
Actual Results
Acceptance
Criteria Met?
(Yes/No)
Discrepancy /
Comment
Comments:
Supporting Data:
Initial / Date:
Initial / Date:
Reviewed
by:
Signature:
Date:
Initial/ Date
Campbell University
System Title
System No.
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Title:
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Document Type
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Objective:
Method:
Tools:
Test Method
Expected Results
Actual Results
Acceptance
Criteria Met?
(Yes/No)
Discrepancy /
Comment
Comments:
Supporting Data:
Initial / Date:
Initial / Date:
Reviewed
by:
Signature:
Date:
Initial/ Date
Campbell University
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Title:
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Objective:
Method:
Tools:
Test Method
Expected Results
Actual Results
Acceptance
Criteria Met?
(Yes/No)
Discrepancy /
Comment
Comments:
Supporting Data:
Initial / Date:
Initial / Date:
Reviewed
by:
Signature:
Date:
Initial/ Date
Campbell University
System Title
System No.
Document No.
Title:
Ver
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Document Type
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Objective:
Method:
Tools:
Test Method
Expected Results
Actual Results
Acceptance
Criteria Met?
(Yes/No)
Discrepancy /
Comment
Comments:
Supporting Data:
Initial / Date:
Initial / Date:
Reviewed
by:
Signature:
Date:
Initial/ Date
Campbell University
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Title:
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Objective:
Method:
Tools:
Test Method
Expected Results
Actual Results
Acceptance
Criteria Met?
(Yes/No)
Discrepancy /
Comment
Comments:
Supporting Data:
Initial / Date:
Initial / Date:
Reviewed
by:
Signature:
Date:
Initial/ Date
Campbell University
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Page _____ of _____

Title:
Support - Signature Record
Objective:
To identify personnel involved in the completion of the protocol.
Method:
Each person involved in the completion of the protocol must enter their name, the name of the company / department they represent, sign and
initial / date the table below.
All personnel involved in the completion of this protocol are identified.
Name
Company / Department
Signature
Initial / Date

Comments:
Supporting Data:
Initial / Date:
Initial / Date:
Reviewed
by:
Signature:
Date:
Campbell University
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APPENDICES
13.1
DISCREPANCY REPORT
Page _____ of _____
DISCREPANCY REPORT
Discrepancy Number
Related Test Protocol

Section / Test Number
Discrepancy Type
Discrepancy
Classification
No cGMP Impact
IQ
OQ
cGMP Impact
Discrepancy Description:
______________________________________________________________________________________________
______________________________________________________________________________________________
______________________________________________________________________________________________
________
______________________________________________________________________________________________
______________________________________________________________________________________________
______________________________________________________________________________________________
______________________________________________________________________________________________
________
Proposed Corrective Action Plan:
______________________________________________________________________________________________
______________________________________________________________________________________________
______________________________________________________________________________________________
______________________________________________________________________________________________
______________________________________________________________________________________________
______________________________________________________________________________________________
___________
An Investigation Is Required? Yes No
Performed By: ________________________________
Date: _________________________
Reviewed By: ________________________________
Date: _________________________
Resolution: Comments:
______________________________________________________________________________________________
______________________________________________________________________________________________
______________________________________________________________________________________________
______________________________________________________________________________________________
________
Discrepancy Satisfactorily Resolved? Yes
If Required Investigation Closed? Yes No
Discrepancy Closed?
Yes No
No
N/A
Performed By: ________________________________
Date: _________________________
Reviewed By: ________________________________
Date: _________________________
Make Copies and Use Additional Sheets As Necessary
Campbell University
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13.3
Document Type
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LIST OF ATTACHMENTS
Page _____ of _____1
Attachment
No.
Number of
Pages
Attachment Title
Reviewed by:
Signature:
Date:
Initial / Date

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Campbell University

Installation / Operational Qualification

INSTALLATION / OPERATIONAL QUALIFICATION

Installation / Operational Qualification

Job Title or Role

Job Title or Role

Installation / Operational Qualification

Codes, Definitions and Abbreviations

System Boundaries / Scope

IOQ Amendment Form

Installation / Operational Qualification

Installation / Operational Qualification

Reason for Revision

Installation / Operational Qualification

CODES, DEFINITIONS AND ABBREVIATIONS

Factory Acceptance Test

National Electrical Code

Operator Interface Terminal

Original Equipment Manufacturer

Occupational Safety and Health Act

Programmable Logic Controller

Standard Operating Procedure

Installation / Operational Qualification

SYSTEM BOUNDARIES / SCOPE

Installation / Operational Qualification

Initial and Date

Installation / Operational Qualification

Page _____ of _____1

Documentation - Calibration Verification Record

Make additional copies as necessary.

Acceptance Criteria Met (Yes/No):

Installation / Operational Qualification

Equipment List Verification

Acceptance Criteria Met (Yes/No):

Installation / Operational Qualification

Engineering & Technical Documentation Verification

Document Type / Title

Acceptance Criteria Met (Yes/No):

Installation / Operational Qualification

Acceptance Criteria Met (Yes/No):

Installation / Operational Qualification

Spare Parts Verification

Acceptance Criteria Met (Yes/No):

Installation / Operational Qualification

Materials in Product Contact

Utilities Requirements Verification

Acceptance Criteria Met (Yes/No):

Installation / Operational Qualification

Utilities Requirements Verification

Acceptance Criteria Met (Yes/No):

PLC Software and Backup Verification

PLC Software and Backup Verification

Installation / Operational Qualification

Installation Qualification Acceptance

Installation / Operational Qualification

Operational Testing (SPECIFICATION 1)

Acceptance Criteria Met (Yes/No):

Installation / Operational Qualification

Operational Testing (SPECIFICATION 1)

Kaye Validator started and

Review data collected to ensure

Data indicates temp is

Qualification run ends

Page _ of _1

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