MCC PRESENTATION - GMP

MANUFACTURING ENVIRONMENTS
Module 5
Presented by :
Deryck Smith Consulting
Engineers
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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.

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.

Validation or Qualification
of a HVAC System ?
Qualification :
The action of proving that any equipment
works correctly and actually leads to the
expected results.

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

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
Planning

3.

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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 in-direct, 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
Developme
nt

Detail Design
(ie. How to make)

IQ Test Plan
(inc.PDI)

Installation
Qualification

Impact
Assessmen
t

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
Developme
nt

Detail Design
(ie. How to make)

(inc.PDI)

Physical Completion
& Inspection

Impact
Assessmen
t

Implementation

ISPE Baseline Guide

Vol.5

17

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 GMPs 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 at-rest 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

Inspectors 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

Inspectors 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

Inspectors 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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