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types of validation, validation


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WATER SYSTEM VALIDATION CONTENTS: Objectives Introduction Validation & System Qualification Monitoring Maintenance Revalidation & Change control Validation documentation

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OBJECTIVE To understand: The need for water quality manual. Reason for usage of pharmaceutical water supply systems. The technical requirements for water supply systems. Different types of water supply systems. Validation requirements. Qualification & inspection requirement

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INTRODUCTION 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 the pharmaceutical manufacturing such as a major component in injectable products and in cleaning of manufacturing equipment . It is one of the raw material that is usually processed by the pharmaceutical manufacturer prior to use because it cannot be supplied by the vendor. Water is thus an important raw material in GMP and in validating the manufacturing process.

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Quality of water should be specific for product quality. Water contains , Organic and inorganic impurities, Microbial contamination, Endotoxin, Particulate contamination. Low quality of water can lead to product degradation, product contamination, loss of product and profit .

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Different grades of Water for Pharmaceutical Purposes- 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 Auxiliary equipment

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WATER STORAGE AND DISTRIBUTION CONSIDERATIONS Materials of Construction (Chemical and Heat Compatibility) Stainless Steel (316 or 316L) Teflon, Silicone, Viton (gaskets, diaphragms) Minimize Dead Legs Smooth Surfaces (Mechanical Polish , Electropolish ) Clean joints (sanitary Tri®Clamp , automatic orbital welding) Passivate interior surfaces to form barrier between water and free iron (0.5 to 1% alkali at 160ºF for 30 minutes followed by 1% Phosphoric Acid or Nitric Acid at 150ºF to 180º F for 10 minutes.)

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Design of the following should be appropriate to prevent recontamination after treatment- 1. Vent filter Sanitary overflow Tank : UV light 2. Conical Bottom : Steam sterilization Combination of on-line (TOC, Conductivity meter etc.) and off-line monitoring (lab testing by proper sampling) to ensure compliance with water specification.


VALIDATION CONCEPT To prove the performance of processes or systems under all conditions expected to be encountered during future operations. To prove the performance, one must demonstrate (document) that the processes or systems consistently produce the specified quantity and quality of water when operated and maintained according to specific written operating and maintenance procedures. Validation involves proving- 1. Engineering design 2.Operating procedures and acceptable ranges for control parameters 3. Maintenance procedures to accomplish it

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The system must be carefully, Designed Installed Tested during processing, after construction, and under all operating conditions. Variations in daily, weekly and annual system usage patterns must be validated.


NEED OF 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


SYSTEM QUALIFICATION : DQ, IQ, OQ AND PQ 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. It is documented the design of the system & will include : Functional Specification.(Storage, purification, etc ) Technical/Performance specification for equipment.(requirements of water volume and flow, define pumps and pipe sizes ) Detailed layout of the system. Design must be in compliance with GMPs and other regulatory requirements.


INSTALLATION QUALIFICATION IQ is in the form of checklist 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

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Cont …. Installation of system as per Design requirements. Installation Verification- Systematic range of adjustments, measurements and tests should be carried out to ensure proper installation. Documentation include details of completed installation.

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Cont …. 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.


OPERATION QUALIFICATION The purpose of OQ is to establish, through documented testing, that all critical components are capable of operating within established limits and tolerances. It is the functional testing of system components mainly the critical components. The purpose of OQ is also to verify and document that the water supply system provides acceptable operational control under “at-rest” conditions.

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Cont …. 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. Ability to maintain any critical parameters(pH, TOC, endotoxin, microbial level, conductivity etc ).

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Cont …. PQ is used to demonstrate consistent achievement of critical parameters over time. (such as pH, TOC, conductivity).


QUALIFICATION PHASES Three phase approach recommended according to WHO Technical Report Series 929 to prove reliability and robustness. To demonstrate that water system is under control and producing water of specified quality for prolonged period of time. Commissioning of water system includes startup of water system with documenting the performance of all system parameters.

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Phase 1 (investigational phase): A test period of 2-4 weeks – monitor the system to operate continuously without failure or performance deviation ,Chemical and microbiological testing should include in accordance with a defined plan.

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Cont …. Sample is taken 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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Cont …. Demonstrate production and delivery of water of the required quality and quantity Use and define the standard operating procedures (SOPs) for operation, maintenance, sanitization and troubleshooting Verify provisional alert and action levels, Develop and define test-failure procedure

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Phase 2(verification step) A further test period of 2-4 weeks – further intensive monitoring of the system Utilization of all the SOPs after the satisfactory completion of phase 1 Sampling scheme generally the same as in phase 1 Water can be used for manufacturing purposes during this phase

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Phase-2 demonstrates : Consistent operation within established ranges. so it demonstrate that the system is in control. Consistent production and delivery of water of the required quantity and quality when the system is operated in accordance with the SOPs.

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Phase 3 (verifying long term control ): 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


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 Tests should include physical, chemical and microbial attributes For example, stable state can be achieved by applying automatic continuous monitoring of TOC and conductivity of the water system. They are the major quality attributes of water by which organic and inorganic impurities can be determined .


MAINTENNCE A controlled, documented maintenance covers Defined frequency with plan and instructions. Calibration programme. SOPs for tasks. Record and review of problems and faults during maintenance.

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Cont …. System sanitization and bioburden control. Systems in place to control proliferation of microbes. Techniques for sanitizing or sterilization. Consideration already during design stage – then validated. Special precautions if water not kept in the range of 70 to 80 c.


REVALIDATION & CHANGE CONTROL Once the validation is completed, the standard operating procedures (SOPs) are formalized. Routine operation should be performed according to the established SOP. If any deviation from SOP observed, determine the change and their impact on whole system. Revalidation and evaluation should be performed depending upon the impact of the change on system.


VALIDATION REPORT Written at the conclusion of the equipment IQ, OQ and at completion of process validation. Will serve as primary documentation for FDA regulatory inspection Will serve as reference document when changes to the system are occurred and revalidation is needed.

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