In this slide contains details about Pharmaceutical validation of water system Presented by: K VENKATSAI PRASAD (Department of pharmaceutical analysis and quality assurance).RIPER, anantapur

1. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Validation of Pharmaceutical
Water System
A Seminar as a part of curricular requirement
for M. Pharm I year II semester
Presented by
K.VenkataSai Prasad (20L81S0402).
Department of Pharmaceutical Quality Assurance.
1

2. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Content Table
2
S.No Content
1 Introduction
2 Grades of Water
3 Different Techniques and Equipments
4 System Qualification
5 Design Qualification
6 Installation Qualification
7 Operation Qualification
8 Performance Qualification
9 Complete Documentation
10 References

3. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Introduction
3
• High-quality water is essential for the manufacturing of
pharmaceuticals. Water is the most commonly used raw material
in pharmaceutical manufacturing.
• Water is directly or indirectly used in pharmaceutical
manufacturing such as major component in injectable products
and in cleaning of manufacturing equipment.
• Water is thus an important raw material in GMP and in validating
the manufacturing process.

4. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 4
Validation of Pharmaceutical
Water System

5. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Validation of Pharmaceutical Water System
• Water is a component of every pharmaceutical product, so Water
system must be validated to ensure the consistent production of
high quality water.
• The pharmaceutical industry places a high priority on the quality
of water used in the production of finished product, intermediate
reagent preparation and analytical processes and especially in case
of parenteral products where quality of water must be as per
pharmacopoeia.

6. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Grades of water Specified in the USP are
classified as
1.Potable water
2.Purified water
3.Water for injection
4.sterile water for injection
5.sterile water for inhalation
6.sterile water for irrigation
7.sterile bacterial static water for injection.

7. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
 The quality attributes of water for a particular application are dictated by
the requirement of its usage. Sequential steps that are used for treating
water for different pharmaceutical purposes are shown in the figure below.

8. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Different Techniques used for Water Treatment
• De-chlorination
• Filtration
• Ultra Filtration
• Softening
• Demineralization
• Reverse Osmosis
• UV Treatment
• Deionization
• Ozonization
8

9. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Different Equipments & Components for Water
System
• Piping
• Valves
• Pumps
• Pressure gauges
• Heat exchangers
• Distillation
• Filters
• Sensors
• Auxiliary equipments
9

10. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Steps of Validation
• Establishing standards for quality attributes.
• Defining system and subsystem.
• Designing equipment, control, & monitoring technologies.
• Establishing standards for operating parameters.
• Developing an IQ stage & OQ stage.
• Establishing alert and action levels
• Developing a prospective PQ stage.
• Completing protocols and documenting each steps.
10

11. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
System Qualification
Validation Master Plan
User Requirements Specifications
Design Qualification
Installation Qualification
Operation Qualification
Performance Qualification
Re-Qualification
11

12. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Design qualification (DQ)
Based on the URS supplier designs the equipment
• This is the 1st step in the qualification of new water supply
system.
• It is documented the design of the system & will include :
- Functional Specifications. (storage, Purification, etc )
- Technical/ Performance specification for equipment.
(requirements for water volume and flow, define pumps
and pipe sizes)
- Detailed layout of the system
• Preliminary preventive maintenance procedures.
• Design must be in compliance with GMPs and other regulatory
requirements.

13. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Installation Qualification
IQ is in the form of check list and it should include
• Instrumentation checked against current engineering drawings
and specifications.
• Review of P&ID.
• Verification of materials of construction.
• Installation of equipment with piping.
• Calibration of measuring instruments.
• Collection and collation of supplier operating and working
instructions and maintenance requirements.

14. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Conti...
• Installation of system as per Design requirements.
• Installation verification-
-System range of adjustments, measurments
and tests should be carried out to ensure
proper installation.
• Documentation include details of completed
installation.

15. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Conti...
IQ Documents should contain
Instrument name, model, I.D. No, Personal responsible for
activities and Date.
A fully verified installation that complies with the documented
design.
All equipments documentation and maintenance requirements
would be documented.
Completed calibration of measuring instruments.
Verification of Materials of construction.

16. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 16
Definition: The purpose of OQ is to establish, through
documented testing, that all critical components are capable of
operating within establibshed limits and tolerances.
•It is the functional testing of system components mainly the
critical components.
Operation Qualification

17. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Conti...
17
Operation Qualification Checks-
• Ability to provide water of sufficient quality and quantity to
ensure achievement of specifications.
• Ability to maintain general parameters like temperature, pressure,
flow at set points.
• Includes the tests that have been developed from knowledge of
processes, systems and equipment.
• Tests include a conditionor a set of condition with upper and
lower operating limits, sometimes referred to as ‘worst case’
conditions.

18. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Performance Qualification
• The purpose of PQ is to verify and document that water supply
system provides acceptable control under ‘Full Operational’
conditions.
• PQ should follow successful completion of IQ and OQ.
According to FDA’s advice
“ The observed variability of the eqipment between and within
runs can be used as a basis for determining the total number of
trails selected for the subsequent PQ studies of the process”

19. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
• Three phases approach recommended according to WHO
Technical Report series 929 to prove reliability and
robustness.
Phase 1 (Investigational Phase)
Test shall be 2-4 weeks (14 days minimum) for monitoring
the system intensively. During this period The system should
operate continuously without failure and performance
deviation.
19
Qualification Phases

20. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Phase 2 (Verification Step)
• A further test period of 2-4 weeks (30 days) should be spent
carrying out further intensive monitoring, while developing all
the refined SOP’s after the satisfactory completion of phase 1.
water can be used for manufacturing purpose during this
phase.
Phase 3
• Phase 3 typically runs for one year after the satisfactory
completion of phase 2. Water can be used for manufacturing
purpose during this phase. After the completion of phase three
of the qualification programme of water system a routine plan
should be established based on the results on phase three.

21. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Validation Report
• Written at the conclusion of the eqipment IQ, OQ and at
completion of process validation.
• Will serve as primary documentation for FDA regulatory
inspection.
• Will serve as reference documet when changes to the system
are occured and revalidation is needed.
21

22. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
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
• Environmental records
• Inspection of plant
Finally certificate (Sign Off) by Engineering, User
(Production) and QA Heads.

23. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
REFERENCES
1. Nash R. A. and Wachter A. H. "Pharmaceuticals Process
Validation"; An international 3rd edition page no. 401-442.
2. Quality Assurance of Pharmaceuticals volume-II GMP &
Inspection WHO.
3. https://bharathpharmacist/water-system-validation.
23

24. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 24