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Protocol No.: ############
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Protocol For The Water System Validation In The Pilot Plant Number of Review: NA
Validation protocol for water purifying system
1.0 Aim..................................................................................................................................3
2.0 Scope...............................................................................................................................3
2.1 System component incorporated in this validating protocol............................................3
2.2 Overview of process and system description...................................................................3
3.0 Roles and Responsibilities...................................................................................................5
4.0 Rationale for system validation............................................................................................6
4.1 Validation of system IQ and OQ......................................................................................6
4.2 Rationale of system validation.........................................................................................7
4.3 Execution of validation....................................................................................................8
4.4 Operational protocol.........................................................................................................8
5.0 Sampling..............................................................................................................................8
5.1 Sampling procedures........................................................................................................8
5.2 Point of sample collection................................................................................................8
5.3 Test to be performed........................................................................................................9
5.3.1 Log entry for equipment and instruments calibration...............................................9
5.4 Acceptable criterion for end product of purified water....................................................9
6.0 Log verification entry...........................................................................................................9
7.0 Preconditions for verification.............................................................................................10
8.0 Execution of protocol for purified water system................................................................10
9.0 Portable water purification.................................................................................................10
9.1 Objectives.......................................................................................................................10
9.2 Procedure........................................................................................................................10
10.0 Conclusions and Summary...............................................................................................11
11.0 Protocol deviation form....................................................................................................11
12.0 Log entry for deviation.....................................................................................................11
13.0 Attachments......................................................................................................................11
14.0 References........................................................................................................................12

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