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Validation of Water Supply System: Maliba Pharmacy College
Validation of Water Supply System: Maliba Pharmacy College
To understand:
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INTRODUCTION
Quality of water should be specific for product
quality.
Water contains,
Organic and inorganic impurities
Microbial contamination
Endotoxin
Particulate contamination
Potable water
Purified water
Water for injection(WFI)
Sterile water for injection, inhalation, irrigation
Sterile bacteriostatic water for injection
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DIFFERENT TECHNIQUES USED FOR
WATER TREATMENT
De-chlorination (Sodium Bisulphite,
Carbon Filter)
Filtration
Ultra Filtration
Softening
Demineralization
Reverse Osmosis
UV Treatment
Deionization
Ozonization
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DIFFERENT EQUIPMENTS AND
COMPONENTS FOR WATER SYSTEM
Piping
Valves
Pumps
Pressure gauges
Heat exchangers
Distillation unit
Filters
Deionizers
Sensors
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Auxiliary equipment
WATER STORAGE AND
DISTRIBUTION – CONSIDERATIONS
Materials of Construction (Chemical and Heat
Compatibility)
Stainless Steel (316 or 316L)
Teflon, Silicone, Viton (gaskets, diaphragms)
Sanitary overflow
Tank UV light
Conical Bottom
Steam sterilization
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WHY VALIDATION OF WATER
SYSTEM?
Most widely used and sometimes most expensive
ingredient
Drug component even if not in product
Generally reviewed in depth by Regulators
Many recalls water related
Always considered direct impact system
To ensure reliable, consistent production of water of
required quality
To operate system within design capacity
To prevent unacceptable microbial, chemical and
physical contamination during production, storage
and distribution
To monitor system performance, storage and
distribution systems
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VALIDATION CYCLE:
It includes four major steps-
Determination of Quality Attributes
Steps of Validation
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DETERMINATION OF QUALITY ATTRIBUTES
The quality attributes, is gaining a clear
understanding of the required quality of water and
its intended use
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THE VALIDATION PROTOCOL
A written plan stating how validation will be
conducted and defining acceptance criteria for
quality.
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ALERT AND ACTION LEVELS:
Alert and action levels are distinct from process
parameters and product specifications.
They are used for monitoring and control rather than
accept or reject decisions.
The levels should be determined based on the statistical
analysis of the data obtained by monitoring at the PQ
step.
Alert levels are levels or ranges that when exceeded
indicate that a process may have drifted from its normal
operation condition.
Alert levels indicate a warning and do not necessarily
require a corrective action. Exceeding an action level
indicates that corrective action should be taken to bring
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the process back into its normal operating range.
SYSTEM QUALIFICATION
Validation Master Plan
Design Qualification
Installation Qualification
Operation Qualification
Performance Qualification
Re- Qualification. 23
DESIGN QUALIFICATION OF WATER SYSTEM
Based on the URS, supplier designs the equipment.
This is 1st step in the qualification of new water supply
systems.
Define process schematically by use of PFD and P&IDs.
Installation Verification-
Systematic range of adjustments, measurements
and tests should be carried out to ensure proper
installation.
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Conti…
• IQ Document should contain,
Instrument name, model, I.D. No., Personnel
responsible for activities and Date.
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.
Verification of Materials of construction.
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OPERATION QUALIFICATION
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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Conti…
Operation Qualification Checks-
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PERFORMANCE QUALIFICATION
The purpose of PQ is to verify and document that
water supply system provides acceptable control
under ‘ Full Operational ‘ conditions.
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Conti…
PQ is used to demonstrate consistent achievement of
critical parameters over time.
(such as pH, TOC, conductivity)
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QUALIFICATION PHASES
Three phase approach recommended according to
WHO Technical Report Series 929 to prove
reliability and robustness.
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Conti…
Sample daily from-
incoming feed-water
after each step in the purification process
each point of use and at other defined sample
points
Develop:
appropriate operating ranges
and finalize operating, cleaning, sanitizing
and maintenance procedures
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Conti…
Phase-2 demonstrates:
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Phase 3
Over 1 year after the satisfactory completion of
phase 2
Water can be used for manufacturing purposes
during this phase
Demonstrate:
extended reliable performance
that seasonal variations are evaluated
Sample locations, sampling frequencies and tests
should be reduced to the normal routine pattern
based on established procedures proven during
phases 1 and 2
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MONITORING
Monitoring and feed back data are important in maintaining
the performance systems. Monitoring parameters include:
Flow, pressure, temperature, conductivity, TOC
Samples taken:
From points of use, and specific sample points
In a similar way how water is used in service
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MAINTENANCE
System sanitization and bioburden control
Systems in place to control proliferation of microbes
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VALIDATION REPORT
Written at the conclusion of the equipment IQ, OQ
and at completion of process validation.
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VALIDATION REPORT
STANDARD FORMAT
1. Executive summary
2. Discussion
3. Conclusions & recommendation
4. List of attachment
Topic should be presented in the order in which they
appear in the protocol.
Protocol deviation are fully explained & justified.
The report is signed & dated by designated representatives
of each unit involved in water system validation.
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Complete Documentation
Verification of design documentation, including
◦ Description of installation and functions
◦ Specification of the requirements
Instructions for performance control
Operating procedures
Maintenance instructions
Maintenance records
Training of personnel (program and records)
Environmental records
Inspection of plant
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THANK YOU
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