Validation plan
Validation plans for water system typically includes the following steps
1.Establishing standards for quality attributes of water to manufacture pharmaceuticals.
2.Defining systems and subsystems suitable to produce the desired water by considering the quality grades of water.
3.Designing equipment, controls and monitoring technologies.
4.Establishing standards for operating parameters of the selected equipment of the system.
5.Developing an IQ stage consisting of instruments calibrations, inspections to verify that the drawings accurately depict the as-built configuration of the system, and special tests to verify that the installation meets design requirements.
6.Developing an OQ stage consisting of tests and inspections to verify that the equipment, system alerts, and controls are operating.
7.Establishing alert and action levels for the operational standards and routine control. This phase of qualification may overlap with aspects of the next step.
8.Developing a prospective PQ stage to confirm the appropriateness of critical process parameter operating ranges. System reproducibility is to be demonstrated in this stage over an appropriate time period. During this phase of validation, alert and action levels for key quality attributes of water, such as TOC, pH particles and microbes are verified.
9.Supplementing a validation maintenance program that includes a mechanism to control changes to the system and establishes and carries out scheduled preventive maintenance, including recalibration of instruments.
10.Instituting a schedule for periodic review of the system performance and requalification.
Completing protocols and documenting steps 1 through 10.
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