This document summarizes water validation and the types of water used in pharmaceuticals. It discusses the reasons for performing water validation when installing a new water system or making changes. The types of water according to IP, BP, and USP standards are described. The key steps in water purification and validation are outlined, including design qualification, installation qualification, operational qualification and performance qualification. Sampling programs are discussed to demonstrate a system is operating under the same conditions as validation. In conclusion, the document covers water standards, uses, equipment, manufacturing processes, and grades of pharmaceutical water specified in key pharmacopeias.

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WATER VALIDATION
Presented by:
Anurag Jain
COLLEGE OF PHARMACY
IPS ACADEMY,INDORE (M.P.)
2006-2007
Supervised by:
Mr. Aakash Singh Panwar

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Key points
Validation
Water validation
Reasons for performing water validation
When and why it is perform?
Types of water as per IP
Types of water as per BP
Types of water as per USP

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Continue….
Quality of water for pharmaceuticals
Steps of Water Purification
Steps of water validation
Sampling
Conclusion
References

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Validation
Validation is the act of demonstrating and
documenting that a procedure operates
effectively. Process validation is the
means of ensuring and providing
documentary evidence that process are
capable of consistently producing a
finished product of required quality1.

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Water Validation
Water validation is used for monitoring the
performance qualifications of purified water.
It establishes documented evidence which
provides a high degree of assurance that a
specific process will consistently produce a
product meeting its pre-determined specifications
and quality attributes.

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Reasons for performing a water
validation
Qualification of a new piece of equipment
New process implementation
Equipment relocation or process change
Major maintenance of equipment2

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. When and why water validation is
perform?
It is performed when the new water system is
installed in the company or there is something
change in the existing water system.
It is performed because the regulatory
requirement which will give the good quality
of water in the future.

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Types of water as per IP
Water for injection
 Purified water
 Water for injection bulk3

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Types of water as per BP
Purified water
Purified water in bulk
Water for injection in bulk
Sterile water for injection4

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Types of water as per USP
Water for injection
Bacteriostatic Water for injection
Sterile water for injection
Sterile water for irrigation
Purified water5

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Quality of water for pharmaceuticals
Medicinal products Min. accepted quality
of water
Parenteral WFI
Ophthalmic Purified
Irrigation solution WFI
Nasal/Ear preparation Purified
Cutaneous preparation Purified
Oral preparation Purified

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Steps of Water Purification
Dechlorination
Carbon bed
Cation bed
Anion bed
Mix bed
Filteration
Reverse Osmosis
Distillation

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Steps of water validation
Design qualification
Installation qualification
Operational qualification
Performance qualification6

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Sampling Program
The purpose of a sampling program is to be
able to demonstrate that a system is operating
under the same conditions as existed during
the validation.
If a system design is such that the system does
not operate consistently, then the reliance on a
small sample as an assurance of quality is
totally unacceptable7.

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Conclusion
This project comprises of different
standards formulation procedures, uses,
equipment used manufacturing processes of
different grades of pharmaceutical water
which are official in Indian Pharmacopoeia,
British Pharmacopoeia and United State
Pharmacopoeia.

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REFERENCES
1. http://www.PDH.center.com (accessed on 24 Aug
2006)
2. http://www.vectorcorporation.com.(accessed on 6
Sep. 2006)
3. Indian Pharmacopoeia, 1996, Purified Water,
Published by the controller of Publication, Govt. of
India; Ministry of Health and Family Welfare –Vol
I, P-807.(accessed on 20 Sep.2006)
4. British Pharmacopoeia, 1998, Water, Published by
The Stationary office under license from the
controller of Her Majesty’s Stationary Office for
the Department of Health on behalf of the Health
Minsters, Vol II, P.A-90.(accessed on 2 Oct. 2006)

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5. http://www.novatx.com/processwater.
Com.(accessed on 9 Oct 2006)
6. http://www.pti-international.com. (accessed on 24
Oct 2006)
7. http:// www.scinces.uts.edu.(accessed on 30 Oct
2006)

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