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MCC PRESENTATION - GMP
MANUFACTURING ENVIRONMENTS
Module 5
Presented by :
Deryck Smith Consulting
Engineers
1
GMP Manufacturing Environments
Air Handling Systems
HVAC Systems
Heating
Ventilation
Air Conditioning
Module 5: Validation, Qualification
& Maintenance
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Validation / Qualification of HVAC
Systems
Topics for this Module:
1.
2.
3.
4.
5.
The definition and need for validation of HVAC
Systems
A qualification approach for HVAC Systems
Retrospective qualification
Inspection of HVAC Systems
Maintenance of HVAC Systems 
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Validation / Qualification of HVAC
Systems
Definition of Validation :
The documented act of proving that any
procedure, process, equipment, material, activity
or system, actually leads to the expected results.
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Validation / Qualification of HVAC
Systems
PIC/S Definition of Validation :
Action of proving, in accordance with the principles of
Good Manufacturing Practice, that any procedure,
process, equipment, material, activity or system
actually leads to the expected results.
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Validation or Qualification
of a HVAC System ?
Qualification :
The action of proving that any equipment
works correctly and actually leads to the
expected results.
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Validation or Qualification
of a HVAC System ?
 A system must be qualified to operate in a validated process
 Equipment and systems are qualified
 A process is validated
 A number of systems make up a process 
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Qualification / Validation Issues
A good design is essential, but it has to be
complemented by:

Qualification of air handling systems

Process validation

Maintenance and periodic re-qualification

Adequate documentation 
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A Qualification approach for HVAC systems
Key Definitions :
• DQ -
Design Qualification
• IQ -
Installation Qualification
• OQ -
Operational Qualification
• PQ -
Performance Qualification
• VMP -
Validation Master Plan
• GEP -
Good Engineering Practice 
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A Qualification approach for HVAC Systems
A Validation Master Plan
User requirement document
Design Qualification
Installation Qualification
Operational Qualification
Performance Qualification
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A Qualification approach for HVAC systems
Qualification requires :
1.
Collaboration of experts
2.
Budget
3.
Planning 
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A Qualification approach for HVAC systems
Planning :
 Which systems are critical / non-critical ? (Risk assessment)
 Direct or indirect impact (ISPE)
 Which aspects of the system will be qualified ?
 Which aspects of the system will be handled under GEP ?
These decisions have implications on the extent, cost and time
of the qualification process.
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A Qualification approach for HVAC Systems
Critical vs non-critical systems :
(Risk or Impact assessment)
 Impact assessment
 Critical component
 Non-critical component
ISPE Definition: Impact assessment is the process
by which the impact of a system on product quality
is evaluated and the critical components within
those systems are identified. 
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Critical Components
• A critical component within a system
where the operation, contact, data,
control, alarm or failure will have a direct
impact on the quality of the product.
• Eg. Supply air fan in an AHU, HEPA filters,
HVAC control system. 
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Non-critical Components
• A non-critical component within a system
where the operation, contact, data,
control, alarm or failure will have an indirect, or no impact on the quality of the
product.
• Eg. Main facility chiller, Eskom high tension
transformer on site. 
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A Qualification approach for HVAC Systems
Model for “Direct Impact” systems
User Requirement
PQ Test Plan
Performance
Qualification
(ie. What)
Functional Design
OQ Test Plan
Operational
(ie. How as schematic)
(inc.FAT)
Qualification
Design
Development
Detail Design
(ie. How to make)
IQ Test Plan
(inc.PDI)
Installation
Qualification
Impact
Assessment
Implementation
ISPE Baseline Guide Vol.5
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A Qualification approach for HVAC Systems
Model for “Indirect Impact” systems
User Requirement
Commissioning Plan
Performance
Testing
(ie. What)
Functional Design
(inc.FAT)
Setting-to-work & Testing
Regulation & Adjustment
(ie. How as schematic)
Design
Development
Detail Design
(ie. How to make)
(inc.PDI)
Physical Completion
& Inspection
Impact
Assessment
Implementation
ISPE Baseline Guide Vol.5
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A Qualification approach for HVAC Systems
The Validation Master Plan
This document should contain :
• Validation policy
• Organizational structure of validation activities
• Summary of facilities, systems, equipment and
•
•
•
•
processes to be validated
Documentation format to be used for protocols and
reports
Planning and scheduling
Change control
References to existing documents 
Ref : PIC/S
Annex.15
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A Qualification approach for HVAC Systems
User requirement specification (URS)
 What operational requirements are there ?
 Required room temperatures and relative humidities
 Cleanroom classifications for the areas
 Single pass or re-circulated HVAC systems ?
 Room pressures / Air flow directions
 GMP requirements 
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A Qualification approach for HVAC Systems
DESIGN QUALIFICATION (DQ)

First step in the qualification of new HVAC
systems.

It documents the design of the system and
will include :
a)
Functional Specification.
b) Technical / Performance specification for equipment.
c)
Detailed Air Flow Schematics.
d) Detailed layout drawing of the system. 
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A Qualification approach for HVAC Systems
A thoroughly executed DQ process ensures the following :
 Compliance with GMP’s and other regulatory requirements.
 Design meets the user requirements.
 Design details facility airflow and pressure cascade philosophy.
 Design takes into account process and personnel flow (cross-contamination issues)
 Design details materials of construction.
 Design details safety requirements.
 Full details of the intended construction prior to implementation.
 Details all equipment that must be ordered. 
ISPE Baseline Guide Vol.5
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A Qualification approach for HVAC Systems
Installation Qualification (IQ)
 The goal of IQ is to verify and document the
quality, installation and integrity of the HVAC system.
 Execution of IQ protocols provides assurance that
a HVAC system is installed in accordance with the
qualified design.
 IQ should highlight discrepancies between design
layouts detailed in the DQ and what has been
constructed (‘As-built” status) 
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A Qualification approach for HVAC Systems
IQ should include, but not be limited to the following :
a) Installation of equipment, piping, services and
instrumentation checked against current engineering
drawings and specifications
b) Collection and collation of supplier operating and
working instructions and maintenance requirements
c) Calibration of measuring instruments requirements
d) Verification of materials of construction 
Ref : PIC/S
Annex.15
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A Qualification approach for HVAC Systems
Practical aspects of IQ :
 Design drawings can be marked up and deviations highlighted.
 DQ to be complete and signed off before IQ begins.
 IQ protocols to be written and approved prior to implementation.
 Check lists for components to be installed can be used. Items such as fans, fan
motors, cooling and heating coils, filters, temperature and relative humidity
sensors and differential pressure gauges can be included in check lists.
 Duct and pipe pressure test reports.
 Filter integrity tests.
 Functionality Loop checks and alarm tests for HVAC control systems. 
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A Qualification approach for HVAC Systems
Practical aspects of IQ (cont.) :
 Calibration of measuring instruments.
 Calibration of additionally used instruments.
 Initial cleaning records.
 Basic commissioning checks.
 Maintenance requirements.
 IQ process checks that the correct components are installed in the correct
location.
 Materials of construction
 Spare parts
 Change controls 
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A thoroughly executed IQ process
ensures the following :
 A fully verified installation that complies with
the documented design. (all deviations will have
been recorded and assessed.)
 All equipment documentation and maintenance
requirements would be documented.
 Completed calibration of measuring
instruments.
 Materials of construction would have been
verified. 
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Operational Qualification (OQ)
• The purpose of OQ is to verify and
document that an HVAC system provides
acceptable operational control under “atrest” conditions.
• ISPE definition : The purpose of OQ is to
establish, through documented testing,
that all critical components are capable of
operating within established limits and
tolerances. 
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Operational control / operation within established limits and
tolerances can be demonstrated by any of the following :



Ability to maintain temperature, relative
humidity and pressure set points.
Ability to provide air of sufficient quality and
quantity to ensure achievement of specified
cleanroom conditions.
Ability to maintain any critical parameters stated
in the DQ consistently. 
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Operational Qualification should include, but
not be limited to the following :
• Tests that have been developed from knowledge
•
of processes, systems and equipment.
Tests to include a condition or a set of
conditions encompassing upper and lower
operating limits, sometimes referred to as ‘worst
case’ conditions. 
Ref : PIC/S
Annex.15
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Practical aspects of OQ :
– IQ reports must be completed and signed off.
– OQ protocols to be written and approved prior to completion.
– Measurement reports are required to demonstrate
achievement of critical parameters as detailed in DQ.
Eg: * Temperature measurement report
* Humidity measurement report
* Differential pressure measurement report
* Air flow direction measurement report
* Room particle count measurement report
* All drawings etc. – done in ‘as-built’ status
* All maintenance/ cleaning instructions available
* All O & M staff to be trained to use and maintain the HVAC system. 
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A Qualification approach for HVAC Systems
PERFORMANCE QUALIFICATION ( PQ)
• The purpose of PQ is to verify and document
•
•
that an HVAC system provides acceptable
operational control under ‘ full operational ‘
conditions.
PQ verifies that over time, the critical
parameters , as defined in the DQ are being
achieved.
PQ should follow successful completion of IQ
and OQ. 
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A Qualification approach for HVAC Systems
PQ should include , but not be limited to the following:-
• Tests, using production materials,
qualified substitutes or simulated
product, that have been developed from
knowledge of the process and facilities,
systems or equipment.
• Test to include a condition or set of
conditions encompassing upper and
lower operating limits. 
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A Qualification approach for HVAC Systems
Practical aspects of PQ:
• PQ is used to demonstrate consistent
achievement of critical parameters over
time. ( under manufacturing conditions)
• PQ is ongoing.
• PQ and OQ tests are sometimes
performed in conjunction with one
another. 
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A Qualification approach for HVAC Systems
Practical aspects of PQ (cont.) :
• PQ tests can consist of the following :Air flow direction tests
Room pressure tests
Room temperature monitoring
Room relative humidity monitoring
Room particle monitoring
Microbiological monitoring 
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Retrospective qualification
• What happens when a detailed DQ, IQ and PQ
•
•
process has not been performed ?
Evidence should be available (or prepared), to
support and verify the operating parameters and
limits for the critical variables of the operating
equipment. Additionally, the calibration,
cleaning, preventative maintenance, operating
procedures and operator training procedures
and records should be documented. ( PIC/S
Annex 15)
Basically only OQ and PQ is carried out. 
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Inspection of HVAC Systems
Inspector’s checklist for validation :
Check that the manufacturer has :
• A VMP and a multi-functional team for
validation
• A planned approach with defined
requirements
• Identified and described processes
• An analysis of the amount of validation
work to perform 
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Inspection of HVAC Systems
Inspector’s checklist for validation (cont.) :
Check that the manufacturer has :
• Selected methods & tools for validation
• Created protocols for execution of the
work
• Performed DQ, IQ, OQ, PQ and
documented the results
• Exerted change control 
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Inspection of HVAC Systems
Inspector’s checklist for validation (cont.) :
Check that the manufacturer has :
• Authentic electronic records & signatures
• Operating & Maintenance Manuals
• “As-built” drawings of the ECS (HVAC
System)
• Schematic layout of the ECS (NB)
• Maintenance schedules 
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Maintenance of HVAC systems
• The validation process should ensure that
all maintenance information is obtained
prior to the handover and use of the
system.
• The validation process should ensure that
preventative and planned maintenance are
put into practice. 
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Maintenance of HVAC systems
What happens when maintenance is done poorly or not
at all ?
• HVAC systems will not achieve the required
•
•
•
•
critical parameters.
Correct air flows may not be guaranteed
Correct room temperature and relative
humidities may not be achieved.
Room cleanliness can be compromised
Cross contamination could be promoted
instead of being prevented. 
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Validation, Qualification and
Maintenance
Summary
• Qualification is a quality tool
• A planned risk assessment based activity
•
•
•
consisting of DQ, IQ, OQ and PQ.
Expensive and time consuming
Requires the manufacturer to assess which
systems are critical and which are less critical.
Used to demonstrate that the systems are under
control. 
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Airflow
Measurement
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Questions & Answers
Presenter contact details:
Deryck Smith Consulting Engineers Inc,
PO Box 39853,
Faerie Glen, Pretoria, 0043
Tel 27 12 991-4010
Fax 27 12 991-7791
Cell 27 82 564-5330
E-mail: deryck@dsce.co.za
Web site: www.dsce.co.za
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