STANDARD OPERATING PROCEDURE

SOP No.: EN-03

Approval Date:

Version No.: 01 QUALIFICATION AND VERIFICATION

FOR HVAC SYSTEM AND AREAS
Next Review Date: Page 1 of 64

TABLE OF CONTENTS
1.0. DEFINITIONS:.............................................................................................................2
2.0. PURPOSE:..................................................................................................................2
3.0. SCOPE:....................................................................................................................... 3
4.0. RESPONSIBILITY:......................................................................................................3
5.0. ENVIRONMENT, HEALTH AND SAFETY:.................................................................4
6.0. PROCEDURE:............................................................................................................4
6.1. General procedure:................................................................................................4
6.2. Numbering system for qualification documents:................................................5
6.3. User Requirement Specification:..........................................................................6
6.4. Design qualification:..............................................................................................7
6.5. Installation qualification:.......................................................................................7
6.6. Operational qualification:......................................................................................8
6.7. Performance qualification:....................................................................................8
6.8. Requalification:......................................................................................................9
6.9. Performance Verification:....................................................................................10
7.0. ABBREVIATIONS:....................................................................................................11
8.0. REFERENCES:......................................................................................................... 11
9.0. ANNEXURES:........................................................................................................... 11

PREPARED BY REVIEWED BY APPROVED BY

Engineering Engineering Head Quality Assurance Manager
Date: Date: Date:
(QA-001/F1/1)
 STANDARD OPERATING PROCEDURE
SOP No.: EN-03
Approval Date:

Version No.: 01 QUALIFICATION AND VERIFICATION

FOR HVAC SYSTEM AND AREAS
Next Review Date: Page 2 of 64

1.0. DEFINITIONS:

1.1. Qualification: Qualification is the act of planning, carrying out and recording of
results on equipment, system premises and facilities which form part of the validated
process to demonstrate that it will perform as intended.
1.2. Qualification Document: This is the written down plan stating how the qualification
will be conducted including all the critical parameters and observation points and
what constitutes acceptance test results.
1.3. User Requirement Specification (URS): A requirement specification that describes
what the equipment or system is supposed to do, thus containing at least a set of
criteria or conditions that have to be met.
1.4. Design Qualification (DQ): Design qualification is documented evidence that the
proposed design of the facilities, system or equipment is suitable for the intended
purpose.
1.5. Functional Design Specification (FDS): Functional design specification is
document that specifies in a complete, precise, variable manner, the requirement
design, behavior or other characteristic of a system or component and often the
procedure for determining whether these provisions have been satisfied.
1.6. Installation Qualification (IQ): Installation qualification is a documented verification
that the facilities, system and equipment as installed or modified, comply with the
approved design and manufacturer's recommendation.
1.7. Operation Qualification (OQ): Operation Qualification is a documented verification
that the facilities, system and equipment as installed or modified, perform as intended
throughout the anticipated operating ranges.
1.8. Performance Qualification (PQ): Performance qualification is the documented
evidence which verifies that the equipment or system operates consistently and gives
reproducibility within defined specifications and parameters over a prolonged period.
1.9. Performance Verification: Performance Verification is a systematic process of
demonstrating that a process performs as intended and will reproducibly meet its
claim.
1.10. Requalification: Reconfirming that the area and equipment, instrument, utilities,
system is meeting the predetermined acceptance criteria after a major change in the
parameters or after a definite period, if there is no change.
2.0. PURPOSE:

2.1. To provide a procedure for performing qualification, verification and requalification of

the HVAC system and areas.

Prepared by
Sign & Date: __________________________
 STANDARD OPERATING PROCEDURE
SOP No.: EN-03
Approval Date:

Version No.: 01 QUALIFICATION AND VERIFICATION

FOR HVAC SYSTEM AND AREAS
Next Review Date: Page 3 of 64

3.0. SCOPE:

3.1. Applicable for the preparation and numbering of qualification, verification and
requalification of documents as well as the performing of the activities of qualification,
verification and requalification of all HVAC system and the areas of service.
4.0. RESPONSIBILITY:

4.1. User Department:

4.1.1. To be a part of qualification team and provide inputs for the user requirement
gathering.
4.1.2. To coordinate for preparation of qualification documents and provide inputs to
engineering team for qualification.
4.1.3. To coordinate with representatives of other departments for qualification efforts.
4.1.4. To monitor the qualification activity in area.
4.2. Engineering:
4.2.1. To document the user requirement in coordination with user department and other
departments.
4.2.2. To prepare qualification, requalification and verification documents.
4.2.3. To be a part of the qualification team and jointly share the efforts for engineering
aspects.
4.2.4. To execute, record and certify the tests which needs engineering measurements.
4.2.5. To perform the tests documented in the qualification documents and recording of the
results in the same.
4.3. EHS:
4.3.1. To provide inputs for the user requirement specification.
4.3.2. To be a part of the qualification team and jointly share the efforts for EHS aspects.
4.3.3. To ensure, record and certify the safety aspects during qualification
4.4. Quality Control:
4.4.1. To provide inputs for the user requirement specification.
4.4.2. To be a part of the qualification team and jointly share the efforts for quality aspects.
4.4.3. To carry out any testing during qualification

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 STANDARD OPERATING PROCEDURE
SOP No.: EN-03
Approval Date:

Version No.: 01 QUALIFICATION AND VERIFICATION

FOR HVAC SYSTEM AND AREAS
Next Review Date: Page 4 of 64

4.5. Quality Assurance:

4.5.1. Issuance of number for qualification documents.
4.5.2. To provide inputs for the user requirement specification.
4.5.3. To be a part of the qualification team and jointly share the efforts for quality aspects.
4.5.4. To review the prepared qualification documents.
4.5.5. To review the results of qualification in the respective documents
4.5.6. To review the schedule for performance verification of HVAC system.
4.6. Quality Assurance Manager: To approve the prepared and executed qualification
documents.
4.7. Supplier / Vendor:
4.7.1. To provide the inputs during installation of HVAC system.
4.7.2. To provide the test certificates of all components e.g. Blower, Motor, Filter, Dampers
etc.
4.7.3. To provide the operation and maintenance manual.
4.7.4. To provide the services as and when required as per customer requirement.
5.0. ENVIRONMENT, HEALTH AND SAFETY:

5.1. Considerations for issues related to EHS to be made during preparation of

qualification document.
6.0. PROCEDURE:

6.1. General procedure:

6.1.1. HVAC system shall be appropriately designed, located, installed, operated and
maintained to suit the intended purpose.
6.1.2. For new HVAC, system change request shall be initiated as per change request SOP
No. QA-006 and impact assessment from responsible function and cross function, as
applicable, shall be performed prior to initiation of the validation procedure.
6.1.3. HVAC code number should be allocated by engineering department in co-ordination
with QA before installation of HVAC as per SOP No._____________.
6.1.4. Where appropriate, new HVAC systems, utilities and equipment shall pass through
all stages of qualification including the preparation of the URS, DQ, IQ, OQ and PQ.
The test execution during qualification shall be either carried out or witnessed by the
qualification team.

Prepared by
Sign & Date: __________________________
 STANDARD OPERATING PROCEDURE
SOP No.: EN-03
Approval Date:

Version No.: 01 QUALIFICATION AND VERIFICATION

FOR HVAC SYSTEM AND AREAS
Next Review Date: Page 5 of 64

6.2. Numbering system for qualification documents:

6.2.1. Numbering of qualification document should be done as SEV/AAA/CCC/XXX.
Where,
6.2.1.1. SEV is the abbreviation for Deseret Microhaem Pharmaceuticals Limited
6.2.1.2. AAA denotes abbreviation as
For Initial Qualification
URS : User Requirement Specification
DQ : Design Qualification
IQ : Installation Qualification
OQ : Operational Qualification
PQ : Performance Qualification
IQ-OQ : in case IQ and OQ will be performed together
OQ-PQ : in case OQ and PQ will be performed together
For Requalification
REDQ : Design Requalification
REIQ : Installation Requalification
REOQ : Operational Requalification
REPQ : Performance Requalification
For Performance Verification: SEV/AAA/CCC
PV : Performance Verification
6.2.1.3. YY is last two digits of calendar year in which qualification is planned.
6.2.1.4. CCC is the abbreviation of the equipment being qualified, e, g., AHU for Air
Handling Unit, VS for Ventilation System, DH for Dehumidifier.
6.2.1.5. XXX is the capacity of the equipment
6.2.1.6. For example: SEV/URS/AHU/13000 is the user requirement specification of an
AHU with capacity 13000 CFM.
6.2.2. Qualification/ periodic performance verification shall be done in accordance with
predetermined and approved documents.
6.2.3. Qualification documents shall have predetermined acceptance criteria (whenever
required) at the time of pre-approval.
6.2.4. The relevant documentation associated with qualification including SOPs,
specifications and acceptance criteria, certificates and manuals shall be maintained
and traceable.
6.2.5. HVAC system shall be maintained in qualified state and undergo periodic
performance verification as well as requalification after change when needed.

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 STANDARD OPERATING PROCEDURE
SOP No.: EN-03
Approval Date:

Version No.: 01 QUALIFICATION AND VERIFICATION

FOR HVAC SYSTEM AND AREAS
Next Review Date: Page 6 of 64

6.2.6. Quality Assurance should be responsible for numbering of HVAC/ area qualification
and verification documents as per above mentioned numbering system.
6.2.7. Quality Assurance should maintain the document number issuance record as per
annexure EN-03/A1.
6.2.8. Master qualification documents shall be maintained by quality assurance
6.2.9. The copies of the qualification documents shall be issued by QA for the recording of
the activity. This should be done by photocopying the master copy and stamping
issued by on first page of the document.
6.2.10. Issuance procedure applies to all qualification documents for HVAC system.
6.2.11. Area requalification documents should be developed separately or commonly for
area based on technical discussion and project requirement.
6.3. User department should allocate the room number with coordination of QA
department
6.4. User Requirement Specification:
6.3.1. The first step of validation stage is preparation of URS. The URS shall be prepared
to define the purpose and requirements to meet the intended purpose. It should be
prepared as per annexure EN-03/A2.
6.3.2. Requirements with respect to functions and supported process and analysis shall be
defined in the URS.
6.3.3. The user requirement specification of HVAC system/ area should be prepared by
engineering department in coordination with representatives of other departments in
qualification team. Consideration should be given to past experience and
performance.
6.3.4. Based on the approved URS, vendor shall submit Functional Design Specification
(FDS). FDS shall be compared against URS in Design Qualification. Once the
design qualification is approved, the user shall proceed for Techno commercial offer
and raise Capital Expenditure Requisition (CER).
6.3.5. If vendor/ supplier is not able to provide the functional design specification, user can
raise the CER based on technical specification/ quotation and the approved FDS/
technical discussion details should be available before finalization of the DQ.
6.3.6. Comparison of requirement specification shall be done to help in selection of vendor
in case more than one vendor is available, before raising a CER.
6.3.7. In case an HVAC is to be procured which has same make, model, capacity etc. as
the existing procured HVAC, the existing URS & DQ shall be referred to in CER &
the qualification documentation.

Prepared by
Sign & Date: __________________________
 STANDARD OPERATING PROCEDURE
SOP No.: EN-03
Approval Date:

Version No.: 01 QUALIFICATION AND VERIFICATION

FOR HVAC SYSTEM AND AREAS
Next Review Date: Page 7 of 64

6.3.8. The change request procedure as per SOP No. QA-006 should be followed for any
change made after approval of the URS.
6.3.9. All parameters identified in the URS should be verified at the appropriate
qualification stages, i.e. installation, operational and performance qualification.
Challenges should be performed to ensure that the parameters are verified for
functionality.
6.5. Design qualification:
6.4.1. The requirements of the URS should be verified during the design qualification.
6.4.2. Design qualification document should be prepared by engineering department in
coordination with user department as per annexure EN-03/A3.
6.4.3. The same annexure EN-03/A3 should be used for the preparation of documents for
requalification.
6.4.4. Any difference observed in URS and FDS needs to be mentioned clearly and
justification based on risk, should be given for acceptance of changes if any.
6.6. Installation qualification:
6.5.1. HVAC system shall be correctly installed in an appropriate location.
6.5.2. During installation, verify the correct installation components, instrumentation,
equipment, pipe work and services against the engineering drawings and
specifications.
6.5.3. Installation qualification document should be prepared by engineering department in
coordination with user department as per annexure EN-003/A4.
6.5.4. The same annexure EN-03/A4 should be used for the preparation of documents for
IQ-OQ and requalification.
6.5.5. Installation qualification of HVAC system/ area should be prepared based on design
qualification and manufacturer's manual / recommendations.
6.5.6. Any deficiency shall be recorded in the qualification document.
6.5.7. Any deficiency that can lead to change in approved design or alter/ having impact
on intended purpose shall be addressed through deviation system. Further
necessary actions/ qualification shall be conducted based in deviation conclusion.
6.5.8. Operational qualification shall be initiated post successful completion of installation
qualification.

Prepared by
Sign & Date: __________________________
 STANDARD OPERATING PROCEDURE
SOP No.: EN-03
Approval Date:

Version No.: 01 QUALIFICATION AND VERIFICATION

FOR HVAC SYSTEM AND AREAS
Next Review Date: Page 8 of 64

6.7. Operational qualification:

6.6.1. Operational qualification document should be prepared by engineering department
in coordination with user department as per annexure EN-003/A5.
6.6.2. Test to be carried out during operational qualification shall confirm operating limits.
6.6.3. Training to relevant personnel shall be completed and recorded in the operational
qualification document. This training can be conducted by equipment manufacturer
representative.
6.6.4. The same annexure EN-003/A5 should be used for the preparation of documents for
OQ-PQ and requalification.
6.6.5. Any deficiency shall be recorded in the qualification document.
6.6.6. Any deficiency having impact on intended purpose of operational requirements shall
be addressed through deviation system. Further necessary actions/ qualification
shall be conducted based on deviation conclusion.
6.6.7. Performance qualification shall be initiated post successful completion of operational
qualification.
6.8. Performance qualification:
6.7.1. Performance qualification should follow the successful completion of IQ and OQ.
6.7.2. HVAC system should consistently perform in accordance with their design
specifications and URS. The performance should be verified in accordance with PQ
document.
6.7.3. Any deficiency shall be recorded in the qualification document.
6.7.4. Any deficiency having impact on intended purpose of performance requirements
shall be addressed through deviation system. Further necessary actions shall be
conducted based on deviation conclusion.
6.7.5. Performance qualification document should be prepared by engineering department
in coordination with user department and quality assurance department as per
annexure EN-03/A6.
6.7.6. The same annexure EN-03/A6 should be used for the preparation of documents for
requalification.
6.7.7. After successful completion of performance qualification, a hand over certificate
should be prepared as per annexure EN-03/A8.

Prepared by
Sign & Date: __________________________
 STANDARD OPERATING PROCEDURE
SOP No.: EN-03
Approval Date:

Version No.: 01 QUALIFICATION AND VERIFICATION

FOR HVAC SYSTEM AND AREAS
Next Review Date: Page 9 of 64

6.9. Requalification:
6.8.1. Requalification of HVAC System/ area should be done in accordance with a defined
schedule.
6.8.2. The frequency of requalification may be determined based on factors such as the
analysis of results relating to calibration, verification and maintenance.
6.8.3. Requalification document for DQ, IQ, OQ and PQ should be prepared by
engineering department in coordination with user department as per annexures EN-
03/A3, EN-03/A4, EN-03/A5 and EN-03/A6 respectively.
6.8.4. Requalification is of two types:
6.8.4.1. Requalification after changes:
6.8.4.1.1. The extent of requalification after a change should be justified based on risk
assessment of the change. Requalification after change should be considered
as part of the change request procedure.
6.8.4.1.2. Any changes to an existing HVAC system shall follow the change request
procedure as per SOP No. QA-006.
6.8.4.1.3. All major areas should be requalified after major change in the area. For
example;
6.8.4.1.3.1. Change in air lock system, airflow pattern, recirculation air percentage, air
changes, installation/ un-installation of point exhaust, installation/ un-
installation of dehumidifiers, pressure balancing, area cleanliness classification
(e.g. ISO Class 7 to ISO Class 8), replacement with new air handling unit, etc.
6.8.4.1.3.2. Conditioning of area temperature and relative humidity changes. (e.g. from
50% to 25% RH and temperature 19 to 25 0C).
6.8.4.1.3.3. Final filtrations evade changes (e.g. addition of extra filters) changes in room
dimensions, direct impact on the product or area, supply/ return point location
change, equipment replacement of different capacity and additional/ new point
exhaust installed.
6.8.4.1.3.4. Any addition, removal or rearrangement of major equipment which will result in
civil work in the area.
6.8.4.1.4. The requalification should not be done for minor changes in the area. E.g. epoxy
painting, painting change, aluminum door replaced with SS door, riser changed
with same size and same location, pass box replaced/ new installed with same
specification, window changed, supply grill changed to SS instead of MS powder
coated, numbering system change for cubicle/ area.

Prepared by
Sign & Date: __________________________
 STANDARD OPERATING PROCEDURE
SOP No.: EN-03
Approval Date:

Version No.: 01 QUALIFICATION AND VERIFICATION

FOR HVAC SYSTEM AND AREAS
Next Review Date: Page 10 of 64

6.8.4.1.5. For the above-mentioned minor changes, impact should be assessed by Quality
Assurance and appropriate environmental monitoring like bio load, fumigation,
temperature and relative humidity study should be performed.
6.8.4.2. Periodic Requalification:
6.8.4.2.1. Periodic requalification should be performed for the HVAC system every 5 years
± 40 days if there are no changes in the AHU.
6.8.4.2.2. The schedule of periodic requalification of HVAC system/ area should be
maintained as per the VMP.
6.8.4.2.3. Periodic Requalification should cover the following aspects:
6.8.4.2.3.1. Verification of performance of AHU.
6.8.4.2.3.2. Verification of temperature and humidity studies.
6.8.4.2.3.3. Verification of microbiological monitoring.
6.10. Performance Verification:
6.9.1. Performance verification reports of HVAC system shall be completed by
engineering department within 30 days from issuance of the document.
6.9.2. Performance verification document of HVAC system / area should be prepared by
engineering department as per annexure EN-03/A7.
6.9.3. Schedule for performance verification of the HVAC system shall be prepared by
engineering as per annexure EN-03/A9.
6.9.4. Master performance verification document to be prepared by engineering
department and issued by quality assurance for respective system (e.g. AHU, VU,
VS, DH, etc.)
6.9.5. The extent, scope and the frequency of qualification and requalification shall be
decided based on risk assessment as per SOP QA-009.
Note 1:

1.1. Calibration of particle counter (Light scattering airborne particle counter) shall be
carried out as per ISO 21501-4.
1.2. Temperature, humidity and microbiological monitoring study can be considered
from routine monitoring schedule during periodic validation.
7.0. ABBREVIATIONS:

AHU : Air Handling Unit

CER : Capital Expenditure Requisition

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 STANDARD OPERATING PROCEDURE
SOP No.: EN-03
Approval Date:

Version No.: 01 QUALIFICATION AND VERIFICATION

FOR HVAC SYSTEM AND AREAS
Next Review Date: Page 11 of 64

CFT : Cross Functional Team

DH : Dehumidifier
DQ : Design Qualification
EHS : Environment Health and Safety
FDS : Functional Design Specification
HVAC : Heating Ventilation and Air Conditioning
IQ : Installation Qualification
ISO : International Organization for Standardization
No. : Number
OQ : Operational Qualification
PQ : Performance Qualification
QA : Quality Assurance
Sr. : Serial
SS : Stainless Steel
URS : User Requirement Specification
VMP : Validation Master Plan
VS : Ventilation System
VU : Ventilation Unit

8.0. REFERENCES:

ISO 14644 : Clean Rooms and associated controlled environment

WHO Technical Report Series No. 961 2011

9.0. ANNEXURES:

Annexure No Annexure Name To be used as

Record of issuance of number to qualification
EN-03/A1 Bound Book
documents (EN-03/F1/1)
EN-03/A2 User Requirement Specification (EN-03/F2/1) Specimen copy

EN-03/A3 Design Qualification Document (EN-03/F3/1) Specimen copy

EN-03/A4 Installation Qualification Document (EN-03/F4/1) Specimen copy

EN-03/A5 Operational Qualification Document (EN-03/F5/1) Specimen copy

EN-03/A6 Performance Qualification Document (EN-03/F6/1) Specimen copy

EN-03/A7 Performance Verification Document (EN-03/F7/1) Specimen copy

EN-03/A8 Handover Certificate (EN-03/F8/1) Specimen copy

Prepared by
Sign & Date: __________________________
 ANNEXURE EN-03/A1
RECORD OF ISSUANCE NUMBER TO QUALIFICATION DOCUMENT

Name of HVAC Name of HVAC

System/ Area Issued By System/ Area Issued By
Qualification
(QA) Sign & (QA) Sign &
Document
Date Date

URS No.

DQ No.

IQ / IQ-OQ No.

OQ/ OQ-PQ No.

PQ No.

REDQ No.

REIQ/ IQ-OQ No.

REOQ/ OQ-PQ No.

RPQ No.

PREDQ No.

PREIQ/ IQ-OQ No.

PREOQ/ OQ-PQ
No.

PREPQ No.

PREQ No.

PV No.

Prepared by
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 ANNEXURE EN-03/A2
(Specimen Copy)

USER REQUIREMENT SPECIFICATION

Document No.: Department:
XXX/URS/CCC/XXX

Version No.: HVAC SYSTEM FOR AREA Date of Issue:

______________________
Supersedes: --- Page 1 of 7

APPROVAL PAGE
Department Name Sign & Date
Prepared By

Engineering

Reviewed By

User Department

Quality Control

Environment, Health &

Safety

Quality Assurance

Approved By

Quality Assurance
Manager

Prepared by
Sign & Date: __________________________ Page 1 of 7 (EN-03/F2/1)
 ANNEXURE EN-03/A2
(Specimen Copy)

USER REQUIREMENT SPECIFICATION

Document No.: Department:
XXX/URS/CCC/XXX

Version No.: HVAC SYSTEM FOR AREA Date of Issue:

______________________
Supersedes: --- Page 2 of 7

INDEX

Sr. No. List of content

1. Purpose
2. Scope
3. Responsibility
4. Requirement Specifications
4.1. Room data for design
4.2. Technical specification (as per the requirements)
5. Material of Construction (MOC)
6. Required Documents
7. Utility available on Site
8. System Performance
9. Safety
10. Location and Environment
11. Compatibility and Support
12. Annexures
13. Abbreviations

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Sign & Date: __________________________ Page 2 of 7 (EN-03/F2/1)
 ANNEXURE EN-03/A2
(Specimen Copy)

USER REQUIREMENT SPECIFICATION

Document No.: Department:
XXX/URS/CCC/XXX

Version No.: HVAC SYSTEM FOR AREA Date of Issue:

______________________
Supersedes: --- Page 3 of 7

1.0. PURPOSE:
1.1. To identify the system and its design specification suitable for the product and
process desired.
1.2. To provide details of structural, functional, cGMP and statutory requirements for
_________________ in order to obtain information and quotation from different
suppliers /vendors.
1.3. To provide a written document to suppliers / vendors with respect to correct design
of system as per the requirement.
2.0. SCOPE
2.1. The scope of this document is limited to to be installed _________________.
The system will be used to for achieving _________________________ in
______area.
2.2. This URS will be recognized as an integral part of the procurement agreement with
the selected system vendor.
2.3. The system supplier or vendor shall abide by the information and conditions set forth
by this document as well as the standard purchasing terms and conditions
of___________________________
3.0. RESPONSIBILITIES:

Department Responsibility Name of person(s)

1. To design, engineer and provide the complete
technical details of System pertaining to its
design qualification viz.
Manufacturer 2. To confirm the safe delivery of the system to
the user site.
3. To highlight any non-compliance in technical
specification.
1. To provide the URS and verify the utilities,
certify components, location and system
Engineering parameters.
2. To also verify the engineering and EHS aspects
of the Area
1. To review details in the user requirement
User Department specification and verify and document all the
critical aspects of area.

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Sign & Date: __________________________ Page 3 of 7 (EN-03/F2/1)
 ANNEXURE EN-03/A2
(Specimen Copy)

USER REQUIREMENT SPECIFICATION

Document No.: Department:
XXX/URS/CCC/XXX

Version No.: HVAC SYSTEM FOR AREA Date of Issue:

______________________
Supersedes: --- Page 4 of 7

Department Responsibility Name of person(s)

Environment, To verify the safety aspects of system, facility and
Health & Safety area.
To review the URS, verify and document all the
Quality
critical aspects of Process/ Product, cGMP and
Assurance
Regulatory guidelines
QA Manager To approve the URS
4.0. REQUIREMENT SPECIFICATIONS:
4.1. Room Data for Design
Sr. Dimension in Meter Occupancy Equipment Lighting
Area
No. Length x Width x Height of Persons Load (Kw) Load (Kw)
1. (_____ x _____ x _____)
2. (_____ x _____ x _____)

4.2. Technical Specification (as per the requirement)

Sr.
Parameter Specifications Remarks
No.
Project
1. Model/ Design cGMP Double skin
requirement
Project
2. Capacity ______________CFM
requirement
Flameproof motor, siemens / ABB / Crompton Project
3. Main motor
make requirement
Blower type: ___________
Static pressure: ______ mm of WC Project
4. Supply air blower
MOC of fan: ________ requirement
Direction of blower should be marked.
Connecting tube size should be M6 or M8.
Differential
The length of the connecting tubes should be
Magnehelic Project
5. NMT 500mm with consideration of protrusion
Gauge/ manometer requirement
of the tube. Applicable for all differential
(if Applicable)
pressure gauges in the cubicle
5.0.

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 ANNEXURE EN-03/A2
(Specimen Copy)

USER REQUIREMENT SPECIFICATION

Document No.: Department:
XXX/URS/CCC/XXX

Version No.: HVAC SYSTEM FOR AREA Date of Issue:

______________________
Supersedes: --- Page 5 of 7

6.0. MATERIAL OF CONSTRUCTION (MOC):

Sr.
Parameters Specifications/dimension Remarks
No.
Process
Outer body: ___________
1. AHU main body and cGMP
Inner body: ____________
requirement
MOC: ______________
Thickness of insulation______ mm
Project
2. Insulation of unit Gasket should be provided at all open able doors,
requirement
joints and sections of AHU. There should not be
any leakage through AHU body.
7.0. REQUIRED DOCUMENTS/ DOCUMENTS TO BE ATTACHED:
Sr.
Parameters Specifications/dimension Remarks
No.
 Material of Construction (MOC)
 Calibration Certificates
1. Certificates
 Motor test certificates
 Filter certificates cGMP
Functional specification with requirement.
2. Should be provide along with quotation
literature.
Operational / instruction Manual and Pl
3. Documents
diagram to be provided
8.0. UTILITY AVAILABLE ON SITE:
Sr.
Parameters Specifications/dimension Remarks
No.
Electricity - 3 ph. + N + E, 4wire
1. Electricity
Voltage: 380 to 440 volts
Operational
2. Chilled water Temp. 5 to 8 0C requirement
3. Hot water Temperature: 30 to 40 0C

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9.0. SYSTEM PERFORMANCE:

Sr.
Parameters Specifications/dimension Remarks
No.
Performance of the system The system is intended to be operated
1.
according to operation. regularly 24 hours, 7 days per week.
Process
Easily accessible for cleaning. Parts which
requirement
2. Cleaning Requirements are required for cleaning should be provided
with quick fixing arrangement.
10.0. SAFETY:
Sr.
Parameters Specifications/dimension Remarks
No.
1. Noise level Should not be more than 90 dB
Safety guards should be provided. For all
2. Safety guards
moving parts.
Blower plenum should have limit switch which
3. Limit switch can switch OFF the blower when plenum door
is opened.
Proper earthing to be provided at two different
4. Earthing connections Safety
points
requirement
FLP/NFLP View lamp should be provided in
View lamp and View blower section with view glass on panel
5.
window Acrylic view window should be provided in
blower section
Indication lamp for the process air blower,
6. Indicator lamp reactivation blower, bed motor, heater bank
should be provided. (If applicable)
11.0. LOCATION AND ENVIRONMENT:
Sr.
Parameters Specifications/ Dimension Remarks
No.
1. Available area 6000 X 4500 X 3200 (L x W x H mm)
Expected size of To be installed at
2. 5000 X 2600 X 3200 (L x W x H mm)
equipment
3. Temperature Condition 15°C to 40°C ______________
4. Relative Humidity NMT 80%

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12.0. COMPATIBILITY AND SUPPORT:

11.1. The operation of system should be user friendly.
11.2. Manufacturer should provide support in case of problems, which may not be able to
rectify at the user end.
11.3. The manufacturer should install and commission the system at the user site and
provide the necessary training to the user for operation and cleaning. Training to be
provided by the manufacturer for the necessary critical steps involved in the
operation and handling of system.
11.4. The manufacture should give at least one-year guarantee and should offer the
service support by email and telephone, if under warrantee; replacement of spares
should be free of cost.
11.5. There should be minimum one-year warranty for the machine.
13.0. ANNEXURES:
Sr. No. Annexure Details Annexure No.

14.0. ABBREVIATIONS:
AHU : Air Handling Unit
cGMP : Current Good Manufacturing Practices
CFT : Cubic Feet Per Minute
dB : Decibel
EPDM : Ethylene Poly Di-Methylene
EU : Euro vent
FLP : Flame proof
HEPA : High Efficiency Particulate Air
HVAC : Heating, Ventilation and Air Conditioning
ISO : International Organization for Standardization
MOC : Material of Construction
MM : Microbial Method
Mm of WC : Millimeter of Water column
MS : Mild Steel
NB : Nominal Bore
NFLP : Non-flame proof
CAPACITY :

MAKE/ SUPPLIER :

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PANEL COLOUR :

PRE-APPROVAL OF PROTOCOL & REPORT

Signatory Name Signature & Date

Prepared by
Engineering

Reviewed by
User Department

Reviewed by
Environment, Health & Safety

Reviewed by
Quality Assurance

Approved by:
Quality Assurance Manager

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INDEX
Sr.
List of content
No.
1.0. Purpose
2.0. Scope
3.0. Project Requirement
4.0. Qualification Team and Responsibility
5.0. System Description
6.0. Pre-requisites
7.0. Room Data
8.0. Critical Variables to Be Met
8.1. Good Manufacturing Practices
8.2. AHU Unit requirement
8.3. Safety
8.4. Location Suitability
9.0. References
10.0. Drawings / documents to be attached
11.0. Supplier documents
12.0. Deviations, if any
13.0. Review (Inclusive of follow up action if any)
14.0. Recommendations /Conclusion
15.0. Abbreviations
16.0. Post approval

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1.0. PURPOSE:
1.1. The purpose of design qualification of the system is to ensure that all the required
critical aspects product / process requirements, cGMP, regulatory guidelines, safety,
security access, ergonomics and environment have been considered in designing
the system and area is properly documented.
2.0. SCOPE:
2.1. The scope of this document is to verify the URS with FDS and evaluation of new
system. The scope of this document is limited to HVAC system of area
3.0. PROJECT REQUIREMENT:
3.1. To design room / procure HVAC system for attaining a required Temperature,
Relative Humidity, Differential Pressure and specifications as per Class / Grade
_____________ with respect to air borne particulate matter and microbial
monitoring.
4.0. QUALIFICATION TEAM AND RESPONSIBILITY:

Department Responsibility Name of person(s)

1. To prepare, evaluate the design parameters
with respect to user requirement specification
(URS), functional design specification, cGMP
Engineering
requirement and record the information.
2. To verify the utilities, certify components,
location and system parameters.
To review the design parameters with respect to
User Department user requirement specification (URS), functional
design specification & cGMP requirement.
To verify the safety aspects of system, facility and
EHS
area
To review the design qualification document and
Quality
to verify and document all the critical aspects of
Assurance
process/ product, cGMP and regulatory guidelines.
Quality
Assurance To approve the design qualification document
Manager

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5.0. SYSTEM DESCRIPTION:

5.1. The system consists of HVAC system consists of AHU with motor, blower, fresh air
filter, pre-filter, intermediate filter, final filter, relief air filter, terminal HEPA filter
(wherever required), cooling coil, heating coil, reactivation unit (wherever required),
desiccant bed (wherever required ), fire dampers, ducting with insulation, piping with
insulation, diffusers, risers, air control dampers etc.
5.2. Working Principle: Blower suck the air from area and partially from environment and
it passes through 10 µ prefilter, 3 µ intermediate filter, cooling coil, hot water I steam
coil , 0.3 µ final plenum filter, 0.3 µ terminal HEPA (If applicable) to concern area to
maintain the required conditions like Temp., RH, pressure differential, particle count
etc.
6.0. PRE-REQUISITES:
6.1. All pre-requites before finalization of DQ should be stated below.
Sr.
Pre-requisite Checked By, Sign & Date
No.
1. Functional Design Specification
2.

7.0. ROOM DATA:

7.1. Dimensions
Dimension in Meter Acceptance Criteria
Sr.
Area (Based on FDS/ Technical Observation
No. Length x Width x Height discussion)
1. (_____ x _____ x _____)
2. (_____ x _____ x _____)
7.2. Occupancy of persons
Acceptance Criteria
Sr.
Area Occupancy of Persons (Based on FDS/ Technical Observation
No.
discussion)
1.
2.

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7.3. Equipment Load

Sr. Equipment Load Acceptance Criteria (Based on
Area Observation
No. (Kw) FDS/ Technical discussion)
1.
2.
7.4. Lighting Load
Sr. Lighting Load Acceptance Criteria (Based on
Area Observation
No. (Kw) FDS/ Technical discussion)
1.
2.
8.0. VARIABLES TO BE MET:
Sr.
Technical Specification
No Parameter Reference Observation
(Acceptance Criteria)
8.1. Good Manufacturing Practices
Temperatu
cGMP
8.1.1. re in the _________ to _______ºC
Requirement
area.
Relative ___ to __ RH (Normal RH)
cGMP
8.1.2. Humidity in NMT __% RH (Low RH,
Requirement
the area wherever required)
8.2. AHU unit requirement
Proj
ect
AHU main Double skin cabinet
8.2.1. requ
body type
irem
ent
Proj
Process
Process and ect
and
8.2.2. Instrument Diagram requ
Instrument
should be provided irem
Diagram
ent
8.2.3. Differential Connecting tube size should Project
Magnehelic be M6 or M8. The length of the requirement
Gauge/ connecting tubes should be
manometer (if NMT 500mm with
Applicable) consideration of protrusion of
the tube. Applicable for all

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Sr.
Technical Specification
No Parameter Reference Observation
(Acceptance Criteria)
differential pressure gauges in
the cubicle

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Sr. Technical Specification

Parameter Reference Observation
No. (Acceptance Criteria)
8.3. Safety
Should not be more than 90 Safety
8.3.1. Noise level
dB requirement
Safety guards should be
Safety
8.3.2. Safety guards provided for all moving
requirement
parts.
8.4. Location Suitability
Electricity - Should be 3 ph.
+ N + E, 4wire line up to the
Panel Board Terminal strips
(Engineering to certify)
Voltage: 380 to 440 volts
Availability of Chilled water from the chiller Project
8.4.1.
utilities at location system for cooling coil. requirement
Temperature: 0 to 6 °C
Hot water Temperature: 30
to 40 ° C
Raw steam at Temp. 140 to
150 °C (Wherever required)
9.0. REFERENCES, IF ANY: Reference to any technical guidelines or documents should
be stated below.
_________________________________________________________________________
_________________________________________________________________________

10.0. DRAWINGS AND DOCUMENTS TO BE ATTACHED:

Sr. No. Drawings/ Documents Title
1.
2.

11.0. SUPPLIER DOCUMENTS: Any supplementary documents received from supplier to

be recorded below.
_________________________________________________________________________
_________________________________________________________________________

12.0.

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13.0. DEVIATIONS, IF ANY: Details of deviations logged to successfully carry out the
exercise results obtained should be recorded below. Current status of the deviation
should be recorded.
Deviation No. PR ID Status of Deviation

14.0. REVIEW (INCUSIVE OF ANY FOLLOW UP ACTIONS, IF ANY): Review the results
obtained and summarize them against the acceptance criteria.
_________________________________________________________________________
_________________________________________________________________________
15.0. RECOMMENDATIONS (INCLUDING REQUIREMENTS OF ANY ADDITIONAL
DOCUMENTATION): Record the recommendations based on the interpretation of
the results.
_________________________________________________________________________
_________________________________________________________________________

16.0. ABBREVIATIONS:
cGMP : Current Good Manufacturing Practices
CFM : Cubic Feet Per Minute
DQ : Design Qualification
17.0. POST APPROVAL: The filled report should be checked and finally signed off by the
team involved in the execution of the activity and reviewing the document.

Signatory Name Signature & Date

Performed by
Engineering
Reviewed by
User Department
Reviewed by
Quality Control
Reviewed by
Quality Assurance
Approved by:
Quality Assurance Manager

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CAPACITY :

MAKE/ SUPPLIER :

PANEL COLOUR :

CODE NO. :

PRE-APPROVAL OF PROTOCOL & REPORT

Signatory Name Signature & Date

Prepared by
Engineering

Reviewed by
User Department

Reviewed by
Environment, Health & Safety

Reviewed by
Quality Assurance

Approved by:
Quality Assurance Manager

INDEX

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Version No.: HVAC SYSTEM FOR AREA Date of Issue:

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Sr. No. List of content

1.0. Purpose
2.0. Scope
3.0. Equipment description
4.0. Qualification Team and Responsibility
5.0. Qualification Acceptance Criteria
6.0. Method of verification
7.0. Checklist for Inspection of Air Handling Unit
8.0. Variables to be met
8.1. Room Data
8.2. AHU
9.0. Drawings and documents to be attached
10.0. Deviations, if any
11.0. Review (Inclusive of follow up action if any)
12.0. Recommendations/Conclusion
13.0. Abbreviations
14.0. Post approval

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1.0. PURPOSE:
1.1. The purpose of installation qualification of the area is to confirm that all specified
attributes of the area have been taken care of in the layout and area has been
constructed according to air handling unit, utility, civil, electrical, instrumentation and
safety etc. for each room covered under air handling unit.
1.2. The purpose of installation qualification of the AHU is to establish that the equipment
and its components are installed as per the approved design specification and
manufacturer recommendations and the systems are operated as per standard
operating procedures and perform in a way to reproduce the results with
consistency.
1.3. All utilities provided are adequate for smooth operation of system and performing as
per regulatory requirements and the cGMP, Product, Process, Safety and statutory
requirements.
2.0. SCOPE:
2.1. The scope of this document is to perform the installation qualification as described in
this installation qualification document at the time of installation of air handling unit
and area covered as per the details below under equipment description.
3.0. EQUIPMENT DESCRIPTION:

AHU Code No.___________ and following Area

Room No. Room name Room No. Room name

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4.0. QUALIFICATION TEAM AND RESPONSIBILITY:

Department Responsibility Name of person(s)

1. To prepare the installation qualification
document.
Engineering 2. To execute the installation and verify the
equipment, utilities, certify components,
location and equipment parameters.
To review the installation qualification document
User Department and verify the equipment after installation for all
proposed parameters and record the same.
To verify the safety aspects of equipment and
EHS
facility
Quality
To review the installation qualification document.
Assurance
Quality
Assurance To approve the installation qualification document
Manager
5.0. QUALIFICATION ACCEPTANCE CRITERIA:
5.1. All components shall be installed as per design qualification specification.
5.2. Material of construction, make, and model of system shall be as per the purchase
order/ design specification.
5.3. Duct lines shall be ensured for no leak and properly insulated.
5.4. All measuring instrument installed shall be numbered, certified /calibrated.
5.5. All heaters are properly installed to avoid electrical hazards.
5.6. All safety parameter should be considered like earthing connection and safety guard.

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6.0. METHOD OF VERIFICATION: The installation qualification document is verified as

per following method; observation should be written as follows:

Sr. No. Method of Verification (MOV) Legend to use

1. Supplier/ Manufacturer's specification S
2. Supplier certificate C
3. Actual check A
4. Visual check V

7.0. CHECKLIST FOR INSPECTION OF AIR HANDLING UNIT:

Chec
ked
Sr.
by,
No Item Acceptance Criteria Make Qty Observation
Sign
.
&
Date
Main AHU
1. Double skin cabinet type
body.
Blower type: Centrifugal,
Supply air backward curved, plug
2.
blower type. MOC: GI, powder
coated.
Should be swirl / four-
Return air
3. way type
diffuser
MOC: SS 304
Checked by (User Department): ___________ Verified by (QA):
_______________
8.0. VARIABLES TO BE MET:
8.1. Room Data

Start Date of Qualification: ___________ End Date of Qualification:

____________

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C
h
e
c
k
e
d
b
Obse y
Sr. Variables to be
Acceptance criteria MOV rvati ,
No. met
on S
i
g
n
&
D
a
t
e
8.1.1. Location
Should be located so as suit
8.1.1.1.Location Suitability the process and minimize
the risk of error.

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Checke
Sr. Variables to be Observatio d by,
Acceptance criteria MOV
No. met n Sign &
Date
Layout of area Should be considered
8.1.1.2. surrounding (In case of existing facility)
8.1.2. Good Manufacturing Practices
Should be unidirectional.
Flow of Personnel Considerations to pass box,
8.1.2.1.
and material airlocks Passage etc. should
be given.
Entry for employees/
8.1.2.2. Entry facility visitors/ contractor should be
considered.
8.1.3. Product/ Process Requirement
Statutory requirement with
Statutory
respect to product and
requirements with
8.1.3.1. process should be
respect to Product
considered (i.e. in process,
and Process.
sampling)
Adequacy of working,
Space or space, number of people
8.1.3.2. availability of the working in the area, /
room equipment size should be
considered.
8.1.4. Architectural Requirements
Floor: The floor (epoxy)
should be hard ____ mm
thick (non-porous)
cleanable, which is durable
and chemical resistant;
There should be no
Construction of
8.1.4.1. crevices. corners should be
room
coved with size ___ mm.
MOC of coving should be
silica. No Impact of Material
Handling equipment (e.g.
trolley movement on the
floor should be considered.)

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Checke
Sr. Variables to be Observatio d by,
Acceptance criteria MOV
No. met n Sign &
Date
8.1.5. Structural Requirements
The room should be
Load bearing constructed on a slab having
8.1.5.1.
capacity a load bearing capacity
___Kg/ m2
a. Electrical _____ phase
and ____ phase
Utilities to be electrical point should
8.1.5.2. provided. (If be provided
applicable)
b. Potable water system to
be provided.
8.1.6. Safety Aspects
a. Audible range of public
address system hooter
Safety should be provided.
8.1.6.1. requirement b. Smoke detector should
(If applicable) be provided.
c. Fire extinguisher should
be provided
8.1.7. Accessories Required
a. Wall railings should be
provided
Civil Accessories b. Floors drain should be
8.1.7.1.
(If applicable) provided
c. Corner angle should be
provided.
Verified by (User Department): ___________

8.2.

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8.3. AHU

Checke
Sr. Variables to be d by,
Acceptance criteria MOV Observation
No. met Sign &
Date
8.2.1. Good Manufacturing Practices
a. Grilles / Diffusers
Type: _______
Supply and return
MOC: _______
air Grilles/
Quantity: _______
8.2.1.1.Diffusers/ Risers/
b. Risers / Diffusers
Terminal HEPA
Type: _______
housings.
MOC: _______
Quantity: _______
8.2.2. Safety
Safety guards should be provided
8.2.2.1. Safety guards
for all moving parts.
Smoke detectorshould be
8.2.2.2.Smoke Detector provided in the return air duct of
the AHU. (If applicable)
8.2.3. Location Suitability
A means of access should be
available around the AHU for
8.2.3.1.Available space
cleaning and maintenance of
equipment.
8.2.4. AHU Unit Requirement
Process and Instruments should be installed
8.2.4.1. Instrument as per Process and Instrument
Diagram Diagram (P and ID)
Connecting tube size should be
Differential M6 or M8. The length of the
Magnehelic connecting tubes should be
8.2.4.2.Gauge/ NMT 500mm with consideration
manometer (if of protrusion of the tube.
Applicable) Applicable for all differential
pressure gauges in the cubicle

Verified by (User Department): ___________

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9.0. DRAWINGS AND DOCUMENTS TO BE ATTACHED:

Sr.
Documents Detail with Annexure no. Annexure No.
No.
1. Copy of preventive maintenance.
2. List of spare parts
3. Area and AHU Ducting layout
4. Filter Test certificates
5. Duct leak test report by Roll star method
6. Supplier drawing
7. Supplier specification
8. Building Load Bearing Capacity certificate
9. Layout for area Surrounding and location Suitability
10. Man, and Material movement layout
11. Equipment location layout
Layout for door opening, room dimension, electrical point and
12.
utility
13. Supplier operating manual
14. Layout for Public address system
15. Area and AHU differential pressure layout.
16. Service floor equipment (AHU) layout

10.0. DEVIATIONS, IF ANY: Details of deviations logged to successfully carry out the
exercise results obtained should be recorded below. Current status of the deviation
should be recorded.
Deviation No. PR ID Status of Deviation

11.0. REVIEW (INCUSIVE OF ANY FOLLOW UP ACTIONS, IF ANY): Review the results
obtained and summarize them against the acceptance criteria.
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________

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12.0. RECOMMENDATIONS (INCLUDING REQUIREMENTS OF ANY ADDITIONAL

DOCUMENTATION): Record the recommendations based on the interpretation of
the results.
_________________________________________________________________________
_________________________________________________________________________

13.0. ABBREVIATIONS:
AHU : Air Handling Unit
Amps : Ampere
cGMP : Current Good Manufacturing Practices
CFM : Cubic Feet Per Minute
dB : Decibel
DQ : Design Qualification
EPDM : Ethylene Poly Di-Methylene
EU : Euro vent
FDS : Functional Design Specifications
14.0. POST APPROVAL: The filled report should be checked and finally signed off by the
team involved in the execution of the activity and reviewing the document.

Signatory Name Signature & Date

Performed by
Engineering
Reviewed by
User Department
Reviewed by
Quality Control
Reviewed by
Quality Assurance
Approved by:
Quality Assurance Manager

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Document No.: Department:
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Version No.: HVAC SYSTEM FOR AREA Date of Issue:

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CAPACITY :

MAKE/ SUPPLIER :

PANEL COLOUR :

CODE NO. :

PRE-APPROVAL OF PROTOCOL & REPORT

Signatory Name Signature & Date

Prepared by
Engineering

Reviewed by
User Department

Reviewed by
Environment, Health & Safety

Reviewed by
Quality Assurance

Approved by:
Quality Assurance Manager

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AHU Code No.___________ and following Area

Room No. Room name Room No. Room name

INDEX

Sr. No. List of content

1.0. Purpose
2.0. Scope
3.0. Qualification team and Responsibility
4.0. Training to personnel for Maintenance and Operation
5.0. Test to be carried out during Operational Qualification
6.0. Parameters checked for Air Handling Unit
7.0. Parameters checked for Area covered
8.0. Parameters checked for Air Handling Unit cum dehumidifier and Area covered
9.0. Air Handling Unit and Area related Document and SOPs
10.0. Test equipment list and Calibration of equipment
11.0. Drawings and documents to be attached
12.0. Deviations, if any
13.0. Review (Inclusive of follow up action if any)
14.0. Recommendations/Conclusion
15.0. Abbreviations
16.0. Post Approval
15.0.

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1.0. PURPOSE:
1.1. The purpose of operational qualification is to demonstrate that individual component
and machine i.e. the entire system (as a whole) is functioning as specified and
record all relevant information to demonstrate that the system is functioning as
expected.
2.0. SCOPE:
2.1. The scope of this document is to perform the operation qualification after the
installation qualification documents has been performed.
3.0. QUALIFICATION TEAM AND RESPONSIBILITY:

Department Responsibility Name of person(s)

To prepare the operational qualification document,
Engineering perform operational qualification and verify the key
functionalities and equipment parameters
User Department To review the operational qualification document.

To verify the safety aspects of equipment and

EHS
facility
Quality
To review the operational qualification document.
Assurance
Quality
Assurance To approve the operational qualification document.
Manager
Operational Qualification started on _______________________
4.0. TRAINING TO PERSONNEL FOR MAINTENANCE AND OPERATION:
4.1. All personnel partaking in qualification activity should be trained. Individual training
details to be stated below.
Name Training Status Checked By

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5.0. TEST TO BE CARRIED OUT DURING OPERATIONAL QUALIFICATION:

S
r
.
Frequency (No. of days to be
Name of Test
carried out)
N
o
.
1. Air change per hour
2. Duct leakage with dropper
3. Return air CFM calculation
4. Fresh air CFM Calculation
5. Relief Air CFM Calculation
6. HEPA Filter integrity test
7. Particulate matter count
8. Temperature and relative humidity
9. Room pressure w.r.t Adjacent room
10. Differential Pressure Across filter bank
11. Air flow pattern test
12. Area recovery test /Clean up test
13. AHU failure test
14. Noise level test
15. Vibration testing report
16. Lux level Measurement test

6.0. PARAMETERS CHECKED FOR AIR HANDLING UNIT:

Sr
Method of Checked
. Variables to be Acceptance Observatio
verificatio by, Sign
N met criteria n
n & Date
o.
Check the operation Manual / Auto
of chilled water line control valves
5.1.
valves and steam should be
line valves. operational

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Sr. Method of Checked

Variables to be Acceptance Observatio
No verificatio by, Sign
met criteria n
. n & Date
Check the chilled Chilled water inlet
water temperature temperature
5.2.
(Utility side) (If should be in
applicable) between _ to _ oC
Check the Chilled Chilled water inlet
water pressure. pressure should
5.3.
(Utility side) (If be in between ___
applicable) to ___ oC

7.0. PARAMETERS CHECKED FOR AREA COVERED:

Checke
Sr. Method of
Variables to be Acceptance Observatio d by,
No verificatio
met criteria n Sign &
. n
Date
6.1. Accessories Required
Civil Accessories Floors drain should
6.1.1.
(If applicable) be operational
6.2. Electrical Accessories
Should be
6.2.1. Electrical point
operational
Lux level in the Should not be less
6.2.2.
area than ___ lux
6.3. Safety Aspect
Audible range of
Should be
6.3.1. Public address
operational
system hooter
Smoke detector (if Should be
6.3.2.
Applicable) operational
6.4. General
Hygrometer (if Should be
6.4.1.
Applicable) operational
BMS sensor or Should be
6.4.2.
LDU box. operational

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Checke
Sr. Method of
Variables to be Acceptance Observatio d by,
No verificatio
met criteria n Sign &
. n
Date
6.5. Utilities (if Applicable)
Portable Water Should be
6.5.1.
line operational
Compressed Air Should be
6.5.2.
lines operational
8.0. PARAMETERS CHECKED FOR AIR HANDLING UNIT CUM DEHUMIDIFIER AND
AREA COVERED:
Checke
Sr. Method of
Variables to be Acceptance Observatio d by,
No verificatio
met criteria n Sign &
. n
Date
Should meet the
requirement of class
Particulate matter
7.1. ___at rest condition.
count
SOP No.______
Version No. ______
____ to ____ 0C
Temperature in
7.2. SOP No.______
the area
Version No. ______
____ to ____ %
Relative Humidity
7.3. SOP No.______
in the area
Version No. ______

9.0. AIR HANDLING UNIT AND AREA RELATED DOCUMENT AND SOPS:
Sr.
Name of SOP Status
No.
1. Equipment operation
2. Cleaning of air filter of HVAC
3. Air Change Validation
4. Planned preventive maintenance of AHU
5. Testing of class of air with particle counter

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Sr.
Name of SOP Status
No.
6. Area recovery period
7. Condition monitoring of area during AHU failure
8. AHU duct Cleaning
9. Checking filter integrity.
10. Sanitation of AHU condensate drain
Condition monitoring and checking pressure differential across the filter
11.
bank.
12. Guideline for checking pressure differential in the cubicle
13. Air flow pattern checking
14. Calibration
15. Equipment breakdown and servicing
16. Microbiology monitoring of Environment in Production area
17. Calibration reports for all testing and measuring equipment
18. Determination of particulate cleanliness classification.
19. Duct leak test
20. Sweep (Clean up) efficiency test
21. Lux level measurement procedure

10.0. TEST EQUIPMENTS LIST AND CALIBRATION OF EQUIPMENT:

10.1. Calibration details of equipment and instruments used to perform tests should be
recorded in the qualification report.
Sr.
Calibration Calibration
No Measuring Equipment Name Code No.
Done On Due On
.
1. Pressure gauges
2. Magnehelic gauges
3. Magnehelic gauges across adjacent area
4. Decibel meter
5. Thermometer
6. Hygrometer

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Sr.
Calibration Calibration
No Measuring Equipment Name Code No.
Done On Due On
.
7. Data Logger
8. Vibration meter
9. Tachometer
10. Ampere meter
11. DOP Test instrument
12. Calibration of Anemometer/ Flow hood
13. Particle counter
14. Duct leak tester

11.0. DRAWINGS AND DOCUMENTS TO BE ATTACHED:

Sr.
Documents Detail with Annexure no. Annexure No.
No.
1. HVAC starting and stopping procedure
2. Instrument calibration report
3. Report of no. of air changes in the area.
4. Duct leakage i.e. in supply air duct
5. Fresh air changes
6. Relief air CFM calculation.
7. Report of return air CFM calculation in the area.
8. Dust collector /Point exhaust CFM calculation
9. Temperature and RH readings in the area.
10. Report of Pressure Differential reading w.r.t. adjacent Area.
11. Pressure differential reading across filter bank
12. Layout of temperature and RH distribution
13. Layout of showing pressure differential in the area.
14. HEPA filter integrity testing report.
15. Particulate matter count report.
16. Layout of particulate count monitoring location.
17. Noise level test report

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Sr.
Documents Detail with Annexure no. Annexure No.
No.
18. Vibration testing record
19. Training Record
20. Lux level measurement record

12.0. DEVIATIONS, IF ANY: Details of deviations logged to successfully carry out the
exercise results obtained should be recorded below. Current status of the deviation
should be recorded.

Deviation No. PR ID Status of Deviation

13.0. REVIEW (INCUSIVE OF ANY FOLLOW UP ACTIONS, IF ANY): Review the results
obtained and summarize them against the acceptance criteria.
_________________________________________________________________________
_________________________________________________________________________
14.0. RECOMMENDATIONS (INCLUDING REQUIREMENTS OF ANY ADDITIONAL
DOCUMENTATION): Record the recommendations based on the interpretation of
the results.
_________________________________________________________________________
_________________________________________________________________________

15.0. ABBREVIATIONS:
AHU : Air Handling Unit
Amps : Ampere
cGMP : Current Good Manufacturing Practices
CFM : Cubic Feet Per Minute
dB : Decibel
DQ : Design Qualification
EPDM : Ethylene Poly Di-Methylene
EU : Euro vent
FDS : Functional Design Specifications
16.0.

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16.0. POST APPROVAL: The filled report should be checked and finally signed off by the
team involved in the execution of the activity and reviewing the document

Signatory Name Signature & Date

Performed by
Engineering
Reviewed by
User Department
Reviewed by
Quality Control
Reviewed by
Quality Assurance
Approved by:
Quality Assurance Manager

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CAPACITY :

MAKE/ SUPPLIER :

PANEL COLOUR :

CODE NO. :

PRE-APPROVAL OF PROTOCOL & REPORT

Signatory Name Signature & Date

Prepared by
Engineering

Reviewed by
User Department

Reviewed by
Environment, Health & Safety

Reviewed by
Quality Assurance

Approved by:
Quality Assurance Manager

AHU Code No.___________ and following Area

Room No. Room name Room No. Room name

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INDEX

Sr. No. List of content

1.0. Purpose
2.0. Scope
3.0. Qualification team and Responsibility
4.0. Testing plan and Frequency
5.0. Parameters checked for Air Handling Unit with Area covered
6.0. References
7.0. Drawings and documents to be attached
8.0. Deviations, if any
9.0. Review (Inclusive of follow up action if any)
10.0. Recommendations/ Conclusion
11.0. Abbreviations
12.0. Post Approval
1.0.

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2.0. PURPOSE:
1.1. The purpose of performance qualification is to determine that the AHU No.:______ is
capable to perform consistently as intended by running the system at rest and
operational conditions and recording all relevant operation capable of consistently
performing consecutive working days and results to demonstrate that the AHU
performance consistency meets predetermined limits under normal conditions
3.0. SCOPE:
2.1. The scope of this document is to be performed after the installation and operational
qualification have been completed and approved
4.0. QUALIFICATION TEAM AND RESPONSIBILITY:

Department Responsibility Name of person(s)

To prepare the performance qualification
document, perform performance qualification and
Engineering
verify the key functionalities and equipment
parameters
User Department To review the performance qualification document.
To verify the safety aspects of equipment and
EHS
facility
Quality
To review the performance qualification document.
Assurance
Quality
To approve the performance qualification
Assurance
document.
Manager
5.0. TESTING PLAN AND FREQUENCY
4.1. Performance qualification is to be performed on the facility.
4.2. Start Date of Qualification: ___________ End Date of Qualification: ____________
4.3. Ensure that the AHU is operational prior to start of any testing or observation.
4.4. Use following table for evaluating performance qualification of the AHU as per
requirement.

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Sr. Frequency (No. of days to be

Name of Test
No. carried out)
1. Particulate matter count at rest condition. Three consecutive days
2. Particulate matter count at operational condition One day Once
Three Consecutive Days – For
3. Temperature and Relative Humidity Manufacturing area
Seven Days – For storage area
4. Room pressure with respect to Adjacent room Three consecutive days
5. Pressure Differential Across filter bank Three consecutive days
Viable count by settle plate exposure and active
6. Three consecutive days
air sampling
Remark: Based on first three days satisfactory micro result at rest studies proceed for in-
operation qualification. Result of remaining 4 days during at rest shall be used for trending
purpose only.
6.0. PARAMETERS CHECKED FOR AIR HANDLING UNIT WITH AREA COVERED:
Checke
Sr. Method of
Variables to be Acceptance Observatio d by,
No verificatio
met criteria n Sign &
. n
Date
Operate the AHU The AHU should be
as per the SOP operational
5.1.
and check SOP No.______
working of AHU Version No. ______
____ to ____ 0C
Temperature in
5.2. SOP No.______
the area
Version No. ______
____ to ____ %
Relative Humidity
5.3. SOP No.______
in the area
Version No. ______
7.0. REFERENCES:
Sr. No. Reference Document
1.
2
8.0.
9.0. DRAWINGS AND DOCUMENTS TO BE ATTACHED:

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Sr.
Documents Details Annexure No.
No.
1. Temperature and relative humidity report.
2. Report of pressure differential reading in the area.
3. Pressure differential across filter bank
4. Particulate matter counts report. At rest condition
5. Particulate matter counts report. At Operation condition
6. Sampling layout of microbial count test including locations
7. Technical Information Sheet report for environmental count.

10.0. DEVIATIONS, IF ANY: Details of deviations logged to successfully carry out the
exercise results obtained should be recorded below. Current status of the deviation
should be recorded.

Deviation No. PR ID Status of Deviation

11.0. REVIEW (INCUSIVE OF ANY FOLLOW UP ACTIONS, IF ANY): Review the results
obtained and summarize them against the acceptance criteria.
_________________________________________________________________________
_________________________________________________________________________
12.0. RECOMMENDATIONS (INCLUDING REQUIREMENTS OF ANY ADDITIONAL
DOCUMENTATION): Record the recommendations based on the interpretation of
the results.
_________________________________________________________________________
_________________________________________________________________________

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13.0. ABBREVIATIONS:
AHU : Air Handling Unit
cGMP : Current Good Manufacturing Practices
CFM : Cubic Feet Per Minute
dB : Decibel
EPDM : Ethylene Poly Di-Methylene
EU : Euro vent
14.0. POST APPROVAL: The filled report should be checked and finally signed off by the
team involved in the execution of the activity and reviewing the document

Signatory Name Signature & Date

Performed by
Engineering
Reviewed by
User Department
Reviewed by
Quality Control
Reviewed by
Quality Assurance
Approved by:
Quality Assurance Manager

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AHU CODE NO. :

PRE-APPROVAL OF PROTOCOL & REPORT

Signatory Name Signature & Date

Prepared by
Engineering

Reviewed by
User Department

Reviewed by
Environment, Health & Safety

Reviewed by
Quality Assurance

Approved by:
Quality Assurance Manager

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1.0. OBJECTIVE:
1.1. To establish that the HVAC system is performing as it is supposed to perform by:
1.1.1. Ensuring that the required temperature, relative humidity and pressure gradient is
within the limit of acceptance criteria.
1.1.2. Ensuring that the quality of air with respect to viable count (total bacterial count,
total fungal count) and non-viable count (particulate matter count) is within the limit
of acceptance criteria.
1.1.3. Ensuring that the total number of air changes, velocity and installed filter system
leakages are within the limit of acceptance criteria.
1.1.4. Ensuring that the airflow direction and visualization is as per requirement.
2.0. JUSTIFICATION FOR SELECTION OF SYSTEM:
___________________________________________________________________
3.0. SCOPE:
3.1. Applicable to all Heating Ventilation and Air Conditioning System which is installed to
control room conditions.
4.0. SITE OF STUDY:
4.1. Department Name: __________________________
4.2. AHU Scope: __________________________
5.0. PERFORMANCE VERIFICATION TEAM AND RESPONSIBILITY:

Department Responsibility Name of person(s)

Engineering To conduct performance verification activity.
User Department Monitoring of area parameters
EHS To verify the safety aspects of the facility
Quality
To review the performance verification document.
Assurance
To approve the performance verification
QA Manager
document.

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6.0. DESCRIPTION OF THE SYSTEM TO BE VERIFIED:

Note:
6.1. Prior to initiation of test, intimation to the respective department, suitable operation of
AHU ventilation unit and operation of supply and exhaust unit, if applicable etc.
6.2. Specify 'NA' wherever not applicable / Circle for appropriate / if other than given
specification, mention separately.
6.3. The acceptance criteria for non-viable particle count should be considered as per EU
GMP European Commission Annex-1 GMP.

Area :
Equipment No. :
Recirculatory
Type of AHU : Once Through 100% supply and exhaust
AHU cum Dehumidifier
Qualification/ Requalification
:
Documents No.
Qualification/ Requalification
:
Date of completion
Previous Performance
:
Verification done on
Design capacity of AHU in CFM :
Grade At Rest In operation
A ISO Class 4.5 ISO Class 4.5
Classification of Area catered B ISO Class 5 ISO Class 5
by HVAC system and particle C ISO Class 7 ISO Class 7
:
count occupancy state at D ISO Class 8 ISO Class 8
which class is achieved. NA ISO Class 9 ISO Class 9
NA Controlled Area NA
NA General NA
Filtration
Fresh air filter (if applicable) : G4 I FS / F6 / EU-4
Return air filter/ pre filter (if
: G4 I FS / F6 / F7 / EU-5
applicable)

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Bag in Bag out filter (if

: F9 / H10 / H11 / H12 / H13 / H14
applicable)
Relief air filter (if applicable) : G4 I F7 / F8 / F9 / H12 / H13 / H14 / EU-5

Dehumidifier filter (if applicable) : F7 / F8 / F9 / H13 / H14/ EU-4/EU-5 EU-7

Intermediate/ Post filter (if
: F6/F7 / F8 / F9/EU-7
applicable)
Fine/ plenum mounted Filter (if
: F7 / F8 / F9 / H12 / H13/H14/ EU-7 / EU-9
applicable)
Terminal filter (if applicable) : H12 / H13 / H14

Motor Rating :
CFM of Reactivation Unit (If
:
applicable)
VFD Rating (If applicable) :

7.0. STANDARD OPERATING PROCEDURE (SOPS) AND MICROBIOLOGICAL

METHODS (MMS) TO BE FOLLOWED:
7.1. Standard Operating Procedure (SOPs)
7.1.1. Operating the HVAC System. SOP No.: ______ Version No.: ___
7.1.2. Recording Temperature and Relative Humidity in the area. SOP No.: _ Version No.:
_
7.1.3. Recording pressure difference with respect to adjacent area/ atmosphere. SOP No.:
_ Version No.: _
7.1.4. Air Velocity measurement and calculation of number of air changes. SOP No.: _
Version No.: _
7.1.5. Checking installed filter system leakages. SOP No.: _ Version No.: _
7.2. Microbiological Method (MM)
7.2.1. Environmental monitoring. MM No.: _ Version No.: _
8.0.

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9.0. CONTROLS
8.1. Calibration of gauges and instruments
Sr.
Code No. / Calibration Calibration
No Item
Serial No. Done On Due On
.
Photometer for checking filter
1.
integrity
2. Particle counter
3. Anemometer/air flow hood
4. Air sampler
Hygrometer/ Data logger/ BMS
5.
sensor
Manometer (across filter)/
6. Magnehelic Gauge I BMS
pressure transmitter
Manometer (on cubicle) /
7. Magnehelic gauge / BMS
pressure transmitter
Pressure gauge on AHU (if
8.
applicable)
Temperature gauge on AHU (if
9.
applicable)
8.2. Training:
8.2.1. All personnel partaking in verification activity should be trained. Individual training
details to be stated below.
Name Training Status Checked By

8.3. Ensure that all required precautions should be taken as per operation SOP.
8.4. Gowning procedure used by personnel should be as per area requirement.
8.5. Risk assessment of HVAC system carried out on: ____________________

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Version No.: HVAC SYSTEM FOR AREA Date of Issue:

______________________
Supersedes: --- Page 6 of 8

8.6. Filter cleaning of AHU out on: ________________________

8.7. Planned preventive maintenance carried out on: ___________________
10.0. TESTING AND FREQUENCY PLAN:
9.1. All tests should be performed as per respective SOP or MM.
9.2. Where BMS is applicable, attach reports.
Sr.
No Test Frequency
.
Installed filter system leakages
Once in six months for sterile
of H11/EU10 filter and better
1. areas and once in 12 months for
than H11/EU10 grade filters (If
non-sterile areas (OSD)
applicable
CFM of inlet air across fresh air
2. Once in 12 months
damper.
11.0. TESTING AND VERIFICATION:
10.1. Where BMS is applicable, attach reports.
Sr.
No Test Acceptance Criteria Observations
.

HVAC System should start

and be operational (ON/OFF
1. Start the HVAC System
status of AHU Ventilation
units)

Installed filter system

Any leakage should not be
leakages of H11/ EU10
more than 0.01% of upstream
2. filter and better than H11/
challenge aerosol
EU10 grade filters (if
concentration
applicable).

12.0. FREQUENCY:
11.1. For classified area and controlled area, one performance verification study in a
year or earlier whenever changes are incorporated in the area, equipment in the
area or in the HVAC system.

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PERFORMANCE VERIFICATION DOCUMENT

Document No.: Department:
XXX/PV/CCC

Version No.: HVAC SYSTEM FOR AREA Date of Issue:

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11.2. For Non-classified areas/ general areas, one performance verification study every
2.5 years or earlier whenever changes are incorporated in the area, equipment in the
area or in the HVAC system. (lf Applicable)
13.0. NON-COMFORMANCES:
12.1. Details of deviations logged to successfully carry out the performance verification and
out of specification results obtained should be recorded below. Current status of the
deviation and OOS should be recorded.
12.1.1. Details of deviation:
Deviation No. PR ID Status of Deviation

12.1.2. Details of out of specification:

Out of specification No. PR ID Status of Deviation

14.0. REVIEW (INCUSIVE OF ANY FOLLOW UP ACTIONS, IF ANY): Review the results
obtained and summarize them against the acceptance criteria.
_________________________________________________________________________
_________________________________________________________________________
15.0. RECOMMENDATIONS (INCLUDING REQUIREMENTS OF ANY ADDITIONAL
DOCUMENTATION): Record the recommendations based on the interpretation of
the results.
_________________________________________________________________________
_________________________________________________________________________

16.0. ABBREVIATIONS:
AHU : Air Handling Unit
cGMP : Current Good Manufacturing Practices
CFM : Cubic Feet Per Minute
dB : Decibel

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PERFORMANCE VERIFICATION DOCUMENT

Document No.: Department:
XXX/PV/CCC

Version No.: HVAC SYSTEM FOR AREA Date of Issue:

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17.0. REFERENCES:
ISO 14644 : Clean Rooms and associated controlled environments
1035-L-0063 : Temperature and Relative Humidity Distribution study in Laboratory
WHO Technical Report Series No. 961 2011
18.0. POST APPROVAL: The filled report should be checked and finally signed off by the
team involved in the execution of the activity and reviewing the document

Signatory Name Signature & Date

Performed by
Engineering
Reviewed by
User Department
Reviewed by
Quality Control
Reviewed by
Quality Assurance
Approved by:
Quality Assurance Manager

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HANDOVER CERTIFICATE

(For HVAC)

This is to certify that

HVAC with AHU/VS of Code No.: ______________

Make: ______________________

Located at _______________________ has been

Qualified and is herewith approved for regular use on __________ (date)

Signatory Name Signature & Date

Engineering

User Department

Environment, Health & Safety

Quality Assurance

Quality Assurance Manager

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SCHEDULE FOR PERFORMANCE VERIFICATION
YEAR: _______________

Performance
Sr. Performance
AHU Code No. Verification Done Remarks
No. Verification Due On
On

Prepared By Reviewed By Approved By

_____________ _____________ _____________ _____________
Quality Assurance
Engineering Department Head Quality Assurance
Manager

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