Quality Water IQ Issue-2

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System: Document No. Revision Number:
CCCCCCCCCC dddddddddd Issue 2
‘Standard Operating Procedure’ for Creation

of an
‘Quality Water IQ protocol’
1.0 Purpose.
This SOP has been raised to ensure all persons involved with originating Quality Water IQ protocols are
familiar with method being used by llllllllll in their facility at mmmmmmmmmm.
2.0 Scope.
The scope of this SOP is restricted to containing sufficient information to enable a qualified person to raise
a Quality Water IQ protocol, to the stage where it is submitted for approval prior to execution, using this
generic template.
3.0 Definitions.
All definitions are given in the company’s Glossary of Terms.
4.0 Method (Procedure).

This document contains a generic Quality Water IQ(IQ) (Pages 7 to 58) along with instructions, in the form
of an SOP (pages 1 to 6), on how, using the SOP sheets, to change this generic IQ into a bespoke IQ for the
equipment you require to validate. Once these instructions are completed and the generic IQ has been fully
populated, the SOP pages 1 to 6 are deleted and the IQ becomes a stand-alone bespoke document.
4.1 Populate IQ.

Make an electronic copy of SOP using Save-As feature in Microsoft Word. The authority to qualify this
equipment must be contained within a Validation Master Plan or A Validation Plan. The scope of validation
must have been determined by the execution Of a Validation Risk Assessment (VRA). Go to section 1..3 of
the generic protocol (page 8 and onwards) and complete Table A. Open SOP Header and replace ‘Insert
Company Name and Address’ with the actual name and address of your company. Contain or abbreviate
this insert to within the allocated box. Close header. Advance to section 1.1, find ‘Parts 820, 210 and
211’. Remove ‘820’ if your are not a Medical Device company.
Open SOP document as a Microsoft Word document, start on this page (1).
In Edit file, open Find. In Find file open Replace. In Replace field type in:
aaaaaaaaaa
In Replace with Field type in the; Authors Name
Select Replace all and press Enter, Repeat as below.
Replace With
Title: Page Number:
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bbbbbbbbbb System Title

cccccccccc Equipment Title
dddddddddd Document Number
ffffffffff Authors Job Title
hhhhhhhhhh System Owners Name
kkkkkkkkkk System Owners Job title
llllllllll Company Name. (briefly)
mmmmmmmmmm Company address (briefly)
Note: All section identities given are now sections in the generic IQ.
4.2 System Overview.

Advance to section 3.1, enter a concise description of the function of the equipment in the product
production cycle. Advance to section 3.2, enter a concise description of the functionality of the equipment.
It is preferable that these two descriptions are plagiarized, the former from the Production Process SOP, and
the latter from the Maintenance / Operation Manual.
4.3 Documentation
Advance to Section 4.1 Table A, enter the title and identification number (where applicable) of all the
documents that are required to be available for review and accountability in the validation of this
equipment.
The Validation Risk Assessment (VRA) rating that this equipment has been assigned (H - M - L) dictates
the documentation that must be available for review. Table A below lists the full range of VRA ratings and
identifies the minimum document requirements deemed acceptable for satisfactory qualification to take
place. The list is not conclusive and if there is further documentation that can be used to verify, that the
equipment construction or installation conforms to requirements specified in the URS, VMP, VP, cGMP’s,
or schedules, then include it.
Table A.
Rationale for Additional or
No Title H M L
missing Documents.
1. Maintenance Manual R R R
2. Parts Manual R R R
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3. Operation Manual R R R
4. Design Specification R R D
5. User Requirements Specification R R D
6. Functional Specification R R
7. Design Specification R R
8. Factory Acceptance Test Results R D
9. Quality Project Plan R D
10. Source Code Review and Report R D
11. Module Test Specification R
12. Software Design Specification. R
13. S/W Integration Test Specification. R
14. S/W Module Design Specification. R
15. S/W Module Test Specification. R
16. Software Test Specification R
17.
18.
19.
R = Required. D = Desirable.
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4.4 Drawings
Advance to Section 4.2 Table A, enter the title and identification number (where applicable) of all the
Drawings that are required to be available, for review and verification in the validation of this equipment.
The Validation Risk Assessment (VRA) rating that this equipment has been assigned (H - M - L), dictates
the minimum drawings that must be available for review. Table A below lists the full range of RIA ratings
and identifies the minimum drawing requirements deemed acceptable. (the validation of this category of
equipment, requires these drawings or equivalents, but is not limited to just these).
Table A.
No. Title H M L Rationale for Additional or
Missing Drawings.
General Assembly R R R
Electrical layout R R R
Parts Assembly R R R
Installation R R D
Interconnection R R
P & ID’s R R
As Built Layouts R R
IO Connections R R
Analogue Connections. R R
R = Required. D = Desirable.
4.5 Component Verification.

Advance to Section 4.3.2, Table A, enter the title and identification number for each system component into
the table.
4.6 Component Record Sheet.

Repeatedly copy and paste in, a Component Record Sheet for each component listed in Table A. On each
component sheet, fill in the part number, serial number and drawing reference number of the component.
4.7 System Sensors.
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Advance to Section 4.5.2, Table A, enter the title and identification number for each system sensor. (Ensure
each sensor has a written justification for its category as required in cGMP’s) into table.
4.8 Sensor Record Sheet.
Repeatedly copy and paste additional Sensor Record Sheets for each sensor listed in 4.5.2 Table A. On each
sensor sheet, fill in the part number, serial number and drawing reference number of the sensor.
4.9 IQ Scope.
The System Tests / Inspection protocol sheets, 4.1 to 4.12 are already in the generic IQ. Do include all of
these sections, even although you may know that that one or two are not applicable. It lets the regulator
know you are aware of these test / inspection requirements. If they are not required, then insert comments
to this effect and sign them off. Addition Test Sheets (13 to 18) are available in the document store (along
with 1 to 12), and can be separately bought and downloaded. These additional test sheets, when required,
should be independently and consecutively pasted in after 4.12. The document should then be checked for
blank pages, chapter sequencing, and numbering.
It is your decision as to where some test scripts go; is it the IQ and OQ? Many Test scripts can go into
either. You should discuss this with the commissioning team manager and jointly agree what is the most
expedient format for your project. The overall content between IQ and OQ is important and regulators will
review your procedure. It is also important to ensure that the work is progressive i.e. you are not adjusting
or modifying something in a way that will invalidate work already done. So once you have arrived at a
format/sequence for your IQ/OQ/PQ tests and inspections; document it in your Validation Plan and get
company approval for the procedure.
Sect. Test Scripts Included in Basic IQ. SKU No. Additional Scripts for Purchase
4.1 System Documentation Verification 11000166 Analog Loop Tests
4.2 System Drawing Verification 11000198 Verification of Vessel Installation
4.3 System Component Verification 11000190 Software Quality Verification
4.4 Electrical Conformance Verification 11000187 S/H/E Environmental Assessments
4.5 Sensor Calibration Verification. 11000182 Valves Test/Inspections Record
4.6 System Future Maintenance. 11000167 Application Software Verification
4.7 Critical Material of Construction 11000166 Analog Loop Tests
4.8 Verification of Lubricants. 11000163 21 CFR Part111 Eligibility
4.9 Security of Back-up Software.
4.10 Analog Address Verification.
4.11 Digital I/O Address Verification.
4.12 Change & Consumable Parts.
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5.00 Completion
On completion of the SOP requirements, sheets 1 to 6 must be deleted and the remaining sheets (the IQ)
must be checked for pagination and general print layout. The completed IQ must now be submitted for
review and contents approval, prior to being executed.
6.0 Role / Responsibilities.

The system owner is responsible for originating this IQ and taking it to ‘approved for execution stage’,
thereafter the Validation Manager is responsible for the administration of the document through to the
satisfactory conclusion of the qualifying process. The document will then be archived and held, in
accordance with the regulatory requirements for completed validation protocols.
7.0 Function and Requirements.

Documentation Procedure.
8.0 Related Documentation References.

VMP, VP, OQ, PQ, Risk Impact Assessment, Calibration Records and Maintenance records.
9.0 Records.
One Shot SOP, destroy after IQ is raised.
10.0 Attachments.
No attachments.
11.0 Project Services Organization Chart.

Not applicable.
http://quality.validation-online.net/equipment.html
END OF SOP CONTENT

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QUALITY WATER IQ
PROTOCOL
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This Quality Water IQ protocol relates to an item of equipment that is the property of llllllllll.. The information contained within this protocol is
propriety information and is the property of lllllllllll. This information may not be copied or disclosed in whole or in part by any third party / parties
without the prior written consent of the company.
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APPROVALS
Engineering Approvers Signature:
Your signature indicates that the documentation and information contained herein complies with the
applicable regulatory, corporate, divisional/departmental requirements and current Good manufacturing
practices.
Name: Signature: Date:
Title: Dept:
QC Approvers Signature:
Your signature indicates that the documentation and information contained herein complies with the
applicable regulatory, corporate, divisional/departmental requirements and current Good manufacturing
practices.
Title: Dept:
Approval of System Owner:
Your signature indicates that this document has been prepared with your knowledge, that you agree with the
purpose and scope of this document, that the document has been reviewed by the appropriate persons and
that you understand the areas of responsibility for your department during execution of this validation plan.
Title: Dept:
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Revision History
Revision No. Date Name Description
Table of Contents
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1 INTRODUCTION..........................................................................................................11
1.1 Origin and Approvals............................................................................................11
1.2 Objectives..............................................................................................................11
1.3 Validation Authority and Scope.............................................................................11
2.0 QUALIFICATION SCOPE............................................................................................12
2.1 Installation.............................................................................................................12
2.2 System Documentation..........................................................................................12
3.0 SYSTEM DESCRIPTION.............................................................................................12
3.1 Description of Equipment Use..............................................................................12
3.2 Description of Equipment Functionality...............................................................12
4.0 VERIFICATION INSPECTIONS AND TESTS............................................................13
4.1 System Documentation Verification......................................................................13
4.2 System Drawing Verification................................................................................18
4.3 System Component Verification............................................................................23
4.4 Electrical Conformance Verification (Minor).......................................................27
4.5 Sensor Calibration Verification.............................................................................29
4.6 System Future Maintenance..................................................................................37
4.7 Critical Area material of Construction Verification...............................................38
4.8 Verification of Lubricants......................................................................................41
4.9 Security of Back-up Software..............................................................................43
4.10 Analog Address Verification..................................................................................44
4.11 Digital I/O Address Verification............................................................................47
4.12 Change & Consumable Parts.................................................................................49
5.0 IDENTIFICATION OF PERSONNEL PERFORMING THIS IQ.................................51
6.0 LIST OF APPENDICES................................................................................................52
7.0 FURTHER ACTIONS REQUIRED...............................................................................53
8.0 CONCLUSIONS............................................................................................................54
8.1 Comments on Results............................................................................................54
1 INTRODUCTION.
1.1 Origin and Approvals.

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This bbbbbbbbbb Quality Water IQ protocol, has been produced by aaaaaaaaaa (ffffffffff), under the
authority of the system owner, hhhhhhhhhh, (kkkkkkkkkk).
This Installation Protocol defines the responsibilities and the procedures that must be complied with to
ensure that the Quality Water IQof this equipment is successfully completed. The successful completion of
this protocol will verify that this installation is in compliance with the Company Quality Standards and the
cGMP requirements as defined in the United States Code of Federal Regulations, Title 21, Parts 820, 210
and 211, and the European Union – Good Manufacturing Practice Directive 91 / 356 / EEC, (EU-GMP).
1.2 Objectives.
The objectives of this Quality Water IQare to ensure that:
1.2.1 The equipment is installed in accordance with design requirements.
1.2.2 The equipment installation satisfies the User Requirement Specifications.
1.2.3 A record of key features of the equipment and components as currently installed is made.
1.2.4 There is sufficient information available to enable the equipment to be operated and maintained
safely, effectively and consistently.
1.2.5 That the equipment has been calibrated to allow Operational Qualification to be performed safely
and with repeatable results.
1.3 Validation Authority and Scope.

Review and complete Table A below. Ensure that both documents are complete, reviewed and approved.
Table A
Validation Authority. VMP or VP Number Initial Date
Validation Requirement Specified in;
Risk Impact Authority ( H-M-L) Risk Impact Assessment No.
VRA Rating & Document Number;
2.0 QUALIFICATION SCOPE.

2.1 Installation
This is an Quality Water IQof the bbbbbbbbbb, as installed in the llllllllll facility in Mmmmmmmmmm.
2.2 System Documentation.

List in Section 4.1.2 Table A, of this protocol, all the documents that are required to enable the degree and
method of software validation specified in section 1.3 of this protocol to be satisfactorily carried out. Other
documentation that must be listed in section 4.1.2 for review of scope and availability include all
documents that are required to service, operate and maintain the equipment.
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3.0 SYSTEM DESCRIPTION.

3.1 Description of Equipment Use.
X
X
X
X
X
X
X
3.2 Description of Equipment Functionality.

X
X
X
X
X
X
X
X
X
X
X
X
X
X
4.0 VERIFICATION INSPECTIONS AND TESTS.
4.1 System Documentation Verification

4.1.1 Rationale
It is required in this protocol to verify that the documentation supplied with this equipment is available and
adequate in scope to ensure that this equipment can be installed, maintained and operated in accordance
with cGMP requirements and the vendors recommendations. 21 CFR Part 820.40
4.1.2 Test Method
Enter all documentation required into Table A below. Copy and paste in sufficient Document Record
Sheets for all documents listed in Table A. Execute record card requirements for each document and sign
and date card. Complete Table A for all documents. For unsatisfactory documents complete the
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appropriate columns in Table A and enter full details of the unsatisfactory aspects of the document into the
document record card.
Table A.
Document
Document Number Document Title Status Initial Date
S US
Table A. (Continued)
Document
Status
Document Number Document Title Initial Date
S US
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Legend: S = Satisfactory. U S = Unsatisfactory.
4.1.2.1 Documentation Record Sheets.

In pursuance of the validation test method given in 4.1.2 of protocol complete all appropriate sections
below; Copy and paste in, sufficient Record Sheets for all documents listed in 4.1.2 Table A.
Document Number Document Title Date Iss. level
Document Scope Comments Initial Date
Document Scope Access Initial Date
Document Scope Location Initial Date

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Document Number Document Title Date Iss. level
Document Scope Comments Initial Date
Document Access Initial Date
Document Location Initial Date
4.1.3 Acceptance Criteria:

All listed documentation must be stored in a secure known location and controlled access for authorized
personnel must be available. The scope of the documentation must be sufficient to ensure that the
equipment can be installed, maintained and operated in accordance with cGMP requirements and vender
recommendations.
4.1.4 Test Results

Review the completed Table A, and confirm by completing the sign off box below, (write into appropriate
cell Pass or Fail) whether the requirements of the acceptance criteria have been fully satisfied.
Comments:
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Sign Off Box

Task Name Signature Initial Date Pass / Fail
Executed
Reviewed
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4.2 System Drawing Verification

4.2.1 Rationale
It is required in this protocol to verify that the drawings supplied with this equipment are available, accurate
and adequate in scope, to ensure that this equipment can be installed, maintained and operated in
accordance with cGMP requirements and the vendors recommendations. 21 CFR Part 820.40 refers.
4.2.2 Test Method
Enter all Drawings available into schedule below and print out schedule record cards for each Drawing
listed. Execute record card requirements for each drawing and sign and date card. Complete Table A for all
Drawing. For unsatisfactory drawings complete the appropriate columns in Table A and enter full details of
the unsatisfactory aspects of the Drawing into the Drawing record card.
Table A.
Drawing
Drawing Number Drawing Title Status Initial Date
S US

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Table A. (Continued)
Drawing
Drawing Number Drawing Title Status Initial Date
S US
4.2.2.1 Drawing Record Sheet.

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In pursuance of the validation test method given in 4.2.2 of protocol complete all appropriate sections
below. Drawing must be compared to installation / equipment and verified using green highlighter where
accurate, and where found inaccurate, highlighted in red. The marked up drawing must be annotated that it
is part of this IQ and must be appended to this protocol (in appendix 1). Copy and paste in, sufficient
Drawing Record Sheets for all Drawings listed in 4.2.2 Table A.
Drawing Number Drawing Title Date Issue level
Drawing Verification; Initial Date
Drawing Access Initial Date
Drawing Location Initial Date
4.2.2.1 Drawing Record Sheet. (Continued)

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4.2.3 Acceptance Criteria:

All listed drawings must be stored in a secure known location with controlled access available for
authorized personnel. All listed drawings must signed off, approved, and reflect the as built condition of the
equipment and or installation.
4.2.4 Test Results

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Comments:
Sign Off Box

Executed
Reviewed
4.3 System Component Verification.
4.3.1 Rationale
It is required in this protocol to verify that all components fitted, are of the correct specification as detailed
in the drawing or schedule of material. 21 CFR Part 211.105 refers.
4.3.2 Test Method

From the drawings or specifications extract and enter in Table A the Part Numbers of all components
specified. Physically inspect these system components, and enter the observed Part Numbers and Serial
Numbers (where given) in Table A. Copy and paste in additional component blocks to Table A, as required.
Table A
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No. Component Part Number Component Actually Installed Initials Date

Specified
Title:
Model
Part No.
Ser. No.
Is the environmental design specification

for this component, robust enough of its
intended area of use?

Specified
Title:
Model
Part No.
Ser. No.

4.3.2 Test Method (Continued)

Specified
Title:
Model
Part No.
Ser. No.


Specified
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Title:
Model
Part No.
Ser. No.


Specified
Title:
Model
Part No.
Ser. No.

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4.3.3 Test Method (Continued)

Specified
Title:
Model
Part No.
Ser. No.

Item Component Part Number Component Actually Installed Initials Date

No. Specified
7 Title:
Model
Part No.
Ser. No.
Is the environmental design specification Comments

intended area of use.
Item Component Part Number Component Actually Installed Initials Date

No. Specified
8 Title:
Model
Part No.
Ser. No.
Is the environmental design specification Comments

intended area of use.
4.3.3 Acceptance Criteria

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The part number of all installed components must agree with the part number specified in the drawing
specification. Component environmental specifications must match or exceed expected installation area
environmental conditions.
4.2.4 Test Results
Examine the records generated (along with any comments) during the execution of this protocol and
entered in Table A. Verify whether the Acceptance Criteria has been fully satisfied. Complete sign off box.
Comments:
Sign Off Box

Executed
Reviewed
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4.4 Electrical Conformance Verification (Minor).
4.4.1 Rationale
It is required in this protocol to verify that all electrical equipment is installed in accordance with cGMP
requirements and follows good electrical practices and procedures. 21 CFR Part 820.70 refers.
4.4.2 Test Method
Complete the requirements of Table A below;
Table A
No. Test/Inspection Record Inspection Results Initial Date
1 Inspect and Test all system components,

doors and removable panels for bonding
together and to earth on each AHU and
associated equipment
2 Check Volts drop of supply voltage, off

load and on load for conformance with
16th edition. Or,
Inspect Portable Appliance test sheet for
conformance and append a copy to this
protocol (in appendix 2).
3 Inspect all harnesses used in this

installation, ensure both ends of harness
are clearly identified.
4 Inspect all cabling and ensure that no

cables are stressed. Ensure all cables /
harness assemblies are securely secured
5 Inspect for cable segregation

requirements on electrical drawings,
ensure any segregations specified have
been complied with.
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Item No. Acceptance Criteria
1 All doors, panels and components must be bonded together and to earth with an impedance
of less than 1.86  (16th edition requirement).
2 All Equipment must cause a voltage drop of less than 4% (measured at the equipment) on its
supply voltage when it is switched from “OFF” to “ON”. If the equipment is serviced from
a plug in distribution point then the equipment must have a valid Portable Appliance Test
Certificate and a copy must be appended to this protocol.
3 All cables assemblies and harnesses must have both ends clearly marked with their identity.
4 All cables and harnesses must be securely mounted clear of floor level.
5 All cable installation must comply with any cable segregation specified on the electrical
installation drawings.
4.4.4 Test Results

Comments:
Sign Off Box

Executed
Reviewed
4.5 Sensor Calibration Verification.

4.5.1 Rationale.
It is required in this protocol to verify that all the sensors used on and with this equipment are calibrated
and that calibration certificates are available to verify this. 21 CFR Part 211.65 refers.
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4.5.2 Test Method

List all Sensors by part number, title and Tag Number below. Complete this and then raise a Sensor
Inspection Sheet for each sensor. In Table A enter tag number and sensor category (critical, non critical).
Complete all Sensor Inspection sheets. Append (in appendix 3) copy calibration certificates for each sensor
listed, to this protocol. Copy and paste in, sufficient Sensor inspection Sheets to ensure that all sensors
listed in Table A, have an Inspection Sheet.
Table A
Initial
No. Title Part No Tag No. C or NC
& Date
C = Critical NC = None-Critical
Table A (Continued)
No. Title Part No Tag No. C or NC Initial

& Date
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4.5.2.1 Sensor Inspection Record.
Title Part Number Tag Number Critical / Non Critical
Verify the following: Record Observations Initial Date

Sensor Serial Number
Sensor has system identity attached.
Sensor has calibration label attached.
Sensor calibration is current
Copy of the calibration certificate is
appended to this protocol.
Sensor has a written class justification.
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4.5.2.1 Sensor Inspection Record. (Continued)


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4.5.3 Acceptance Criteria.

All sensors used with this equipment which have been classified as CRITICAL must be in a
calibrated condition. The testing standards used must be traceable to national standards, and a
copy of the calibration certificate stating this, must be appended to this protocol. The sensors must
be identified with a tag number and carry a calibration label, displaying when next calibration is
due and identity of who carried out the current calibration. All CRITICAL sensors must be listed
in a log, and carry a unique identifying serial number. There must be a written justification for the
sensor classification as critical or none-critical.
All sensors which have been classified as NON CRITICAL must carry labels stating that they are
not calibration and are there, FOR REFERENCE PURPOSES ONLY.
4.5.4 Test Results
Examine the records generated during the execution of this protocol and verify that the Acceptance
Criteria has been fully satisfied. Complete sign off box.
Comments:
Sign Off Box

Executed
Reviewed
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4.6 System Future Maintenance.
4.6.1 Rationale
It is required in this protocol to verify that once this equipment is qualified it will be maintained to
a standard that will not compromise its validated status. 21 CFR Part 820.70 refers.
4.6.2 Test Method
Review Preventative maintenance schedule for scope and frequency of action and determine its
adequacy.
Title of maintenance System Initial Date
System Maintenance Reference Identity
Frequency of maintenance action Considered Adequate Initial Date
Scope of maintenance action

Maintenance schedules must be sufficiently rigorous to ensure the systems validated status is not
compromised.
4.6.4 Test Results
Examine the records generated during the execution of this protocol and verify that the Acceptance
Criteria has been fully satisfied. Complete sign off box.
Comments:
Sign Off Box

Executed
Reviewed
4.7 Critical Area material of Construction Verification.

4.7.1 Rationale
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It is required in this protocol to verify that all product contact parts are manufactured from 316L
stainless steel or to a specification otherwise authorized. 21 CFR Part 211.105 refers.
4.7.2 Test Method
List all the product contact parts in Table A below. From supporting documentation and
certificates, verify the material of construction. Append copy of certificates to this protocol in
appendix 4. Complete Table A.
Table A
Details of Product Contact Parts
Specifications
Product Contact Materials of Initial
Parts Certificate
Construction &
Design Actual Number Date
Drawing No.

All product contact parts must be manufactured from 316L stainless steel, unless there is an approved
specification to the contrary. There must be documented verification of the material of construction.
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Where possible this should be appended to this protocol. Where this is not practical, comments should
rationalize why not and detail where it is archived.
4.7.4 Test Results
entered in Table A. Verify whether the Acceptance Criteria has been fully satisfied. Complete sign off box.
Comments:
Sign Off Box

Executed
Reviewed
4.8 Verification of Lubricants.

4.8.1 Rationale.
The FDA has issued guidance documents for the selection of lubricants that are to be used in the
pharmaceutical industry, it is required in this protocol to verify that the lubricants to be used in the
maintenance and use of this equipment conform to these requirements. 21 CFR Part 178.3570,
Part 178.3620, Part 211.65, Part 174.5 & Part 174.6 refers.
4.8.2 Test Method
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List below all the Lubricants that are recommended for use with this equipment. Compare these
lubricant specifications with the requirements of CFR’s and complete the table requirements.
Table A
Vendor Recommendation Lubricants Purpose Compliant Initial Date
Yes / No
Lubricant use is 21 CFR 174.5 Compliant
Lubricants use is 21 CFR 211.65 Compliant
Lubricant use is 21 CFR 174.6 Compliant

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All Lubricants used with pharmaceutical equipment must conform where applicable, to the
pharmaceutical directives contained within 21 CFR Part 178.3570 and Part 178.3620. If the use of
lubricants is permissible then it is required to ensure that 21 CFR Part 211.65, Part 174.5 & Part
174.6 have been complied with.
4.8.4 Test Results

Examine the records generated (along with any comments) during the execution of this protocol
and entered in Table A. Verify whether the Acceptance Criteria has been fully satisfied. Complete
sign off box.
Comments:
Sign Off Box

Executed
Reviewed
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4.9 Security of Back-up Software.
4.9.1 Rationale
The operation of the equipment is controlled by the software, it is required in this protocol to verify that the
backup copy of this software is available and that it is stored in a weather and fire proof area, remote to its
area of use, and that access to it is controlled.
4.9.2 Test method
Locate backup software and confirm storage and access conditions.
Table A
Observations YES /
NO
Stowage of backup software conforms to the acceptance criteria

requirements
Stowage of backup software does not conform to the acceptance criteria

requirements

Backup software program must be stored in a secure weather and fire-proof area
remote to area of use. Access to this software must be restricted to authorised
personnel and documented.
4.9.4 Test Results

Review completed Table A and confirm whether the Acceptance Criteria requirements have been satisfied.
Comments:
Sign Off Box

Executed
Reviewed
Title: Page Number:
BBBBBBBBBB 42 of 52
4.10 Analog Address Verification.
4.10.1 Rationale
It is required in this protocol to verify that all analog addresses are as specified in the system
drawing and or specification
4.10.2 Test Method

Inspect each analogue input and output address and confirm the wire number attached to it.
Record in Table A below.
Table A
Input Address Wire Number Initials date Comments

Title: Page Number:
BBBBBBBBBB 43 of 52
Output Address Wire Number Initials date Comments

Title: Page Number:
BBBBBBBBBB 44 of 52

The analogue inputs and output wires must be to the addresses given in the drawing or the drawing
specification..
4.10.4 Test Results

and entered in Table A. Verify whether the Acceptance Criteria has been fully satisfied. Complete
sign off box.
Comments:
Sign Off Box

Executed
Reviewed
4.11 Digital I/O Address Verification.
4.11.1 Rationale
It is required in this protocol to verify that all digital addresses are as specified in the system
drawing and or specification
Title: Page Number:
BBBBBBBBBB 45 of 52
4.11.2 Test Method

Inspect each digital input and output address and confirm the wire number attached to it. Record
in Table A, below.
Table A
Digital Address Wire Number Initials date Comments
Extend Table as required.

Title: Page Number:
BBBBBBBBBB 46 of 52

The digital inputs and output wires must be to the addresses given in the drawing or the drawing
specification..
4.11.4 Test Results

entered in Table A. Verify whether the Acceptance Criteria has been fully satisfied. Complete sign
off box.
Comments:
Sign Off Box

Executed
Reviewed
4.12 Change & Consumable Parts.
4.12.1 Rationale
Title: Page Number:
BBBBBBBBBB 47 of 52
It is required in this protocol to verify that where, consumable and change parts are required to
maintain the performance of this equipment to within its validated status, that these parts are
genuine makers parts and are available.
4.12.2 Test Method

Extract from the manufacturers maintenance manuals, the change parts that are listed as field
change parts. Verify that these parts are, available, genuine and stored in accordance with the
makers instructions. Complete Table A accordingly.
Table A
Store
Parts Title Parts Number In Stock Genuine Date Signature
Correct

Change and consumable parts as specified by the equipment manufacturer, must be stored in
accordance with the manufacturer’s instructions and readily available to the equipment operators.
Title: Page Number:
BBBBBBBBBB 48 of 52
4.12.4 Test Results

and verify whether the Acceptance Criteria has been fully satisfied. Complete sign off box.
Comments:
Sign Off Box

Executed
Reviewed
5.0 IDENTIFICATION OF PERSONNEL PERFORMING THIS IQ.

In the table below enter the details of the people involved with this Installation Qualification. Attach as
appendices to this protocol the curriculum vitae for all the non - llllllllll company personnel listed below.
The training records for all llllllllll personnel are held on file and can be inspected at the QA department.
PERSONNEL
Signatures
Company / Dept Name Date
Full Initials
Title: Page Number:
BBBBBBBBBB 49 of 52
For Name: Print your name and initials.
For Initials: Provide the normal way in which you identify yourself using initials, as you have or may
have used your initials in the body of the protocol.
For Signature: Enter your signature as you have or may have used your signature in the body of the
protocol.
Job Title: If you are a llllllllll employee enter your job title, if not enter the name of the company for
whom you work.
Title: Page Number:
BBBBBBBBBB 50 of 52
6.0 LIST OF APPENDICES
Appendix Number of
Document identity Reference Section
Number Pages
Title: Page Number:
BBBBBBBBBB 51 of 52
7.0 FURTHER ACTIONS REQUIRED

(If none, enter “NONE” in the first empty box).
Corrective
Protocol Is There GMP
Further Action Required. Action
Section. Implications?
Number.
Title: Page Number:
BBBBBBBBBB 52 of 52
8.0 CONCLUSIONS
8.1 Comments on Results
According to the information collected and reviewed as a result of this Installation Study, it is our opinion
that the required work has been / has not been completed and satisfactory results have been / have not
been obtained, with the exception of those related to the following items on which corrective action is
required:
(Bold: Delete as required.)
Number of items requiring Corrective Action: …………………………

Details of these are contained in Section 7.
This Quality Water IQcannot be approved or permission to proceed to Operation Qualification execution
given, if any of the outstanding Corrective Actions (CA) could in anyway compromise the company’s
cGMP procedures or standards.
The number of outstanding CA’s is: …………………..
Do these CA’s have cGMP implications: ………………….
Signing this block below confirms that all variations and failures listed within this Quality Water IQ have
been accounted for in the IQ Report. This IQ has therefore been completed.
QUALITY WATER IQ COMPLETION
Title Name Signature Date

Quality Water IQ Issue-2

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Title: Page Number:

‘Standard Operating Procedure’ for Creation

4.0 Method (Procedure).

4.1 Populate IQ.

Select Replace all and press Enter, Repeat as below.

bbbbbbbbbb System Title

4.2 System Overview.

4.5 Component Verification.

4.6 Component Record Sheet.

6.0 Role / Responsibilities.

7.0 Function and Requirements.

8.0 Related Documentation References.

11.0 Project Services Organization Chart.

END OF SOP CONTENT

Engineering Approvers Signature:

Name: Signature: Date:

Name: Signature: Date:

Approval of System Owner:

Name: Signature: Date:

Revision No. Date Name Description

1.1 Origin and Approvals.

1.3 Validation Authority and Scope.

Validation Requirement Specified in;

Risk Impact Authority ( H-M-L) Risk Impact Assessment No.

VRA Rating & Document Number;

2.0 QUALIFICATION SCOPE.

2.2 System Documentation.

3.0 SYSTEM DESCRIPTION.

3.2 Description of Equipment Functionality.

4.0 VERIFICATION INSPECTIONS AND TESTS.

4.1 System Documentation Verification

Legend: S = Satisfactory. U S = Unsatisfactory.

4.1.2.1 Documentation Record Sheets.

Document Number Document Title Date Iss. level

Document Scope Comments Initial Date

Document Scope Access Initial Date

Document Scope Location Initial Date

Document Number Document Title Date Iss. level

Document Scope Comments Initial Date

Document Access Initial Date

Document Location Initial Date

4.1.3 Acceptance Criteria:

4.1.4 Test Results

Sign Off Box

4.2 System Drawing Verification

Legend: S = Satisfactory. U S = Unsatisfactory.

Legend: S = Satisfactory. U S = Unsatisfactory.

4.2.2.1 Drawing Record Sheet.

Drawing Number Drawing Title Date Issue level

Drawing Verification; Initial Date

Drawing Access Initial Date

Drawing Location Initial Date

4.2.2.1 Drawing Record Sheet. (Continued)

Drawing Number Drawing Title Date Issue level

Drawing Verification; Initial Date

Drawing Access Initial Date

Drawing Location Initial Date

Drawing Number Drawing Title Date Issue level

Drawing Verification; Initial Date

Drawing Access Initial Date

Drawing Location Initial Date

4.2.3 Acceptance Criteria:

4.2.4 Test Results