Qualification of pharmaceutical water system involves three phases:

• Phase -1
• Phase -2
• Phase -3

Phase -1:

A test period of 2-4 weeks should be spent for monitoring the system intensively. During this period the system should operate continuously without failure or performance deviation.Water cannot be used for pharmaceutical manufacturing in this phase.The following should be included in testing approach.

• Under take chemical & microbiological testing in accordance with a defined plan.
• Sample incoming feed water daily to verify its quality.
• Sample each step of purification process daily.
• Sample each point of use daily.
• Develop appropriate OPERATING ranges.
• Demonstrate production and delivery of product water of required quantity and quality.
• Use and refine the SOP’s for operation,maintenance,SANITIZATION and trouble shooting.
• Verify provisional alert and action levels.
• Develop and refine test failure procedure.

Phase -2:

A further test period of 2-4 weeks. Sampling scheme will be same as Phase – 1.Water can be used for manufacturing process in this phase. Approach should also

• Demonstrate consistent operation within established ranges.
• Demonstrate consistent production & delivery of water of required quality and quantity.

Phase - 3:

Phase 3 runs for one year after satisfactory completion of phase-2.Water can be used for manufacturing process during this process.

Objectives & Features of Phase -3:

• Demonstrate extensive reliable performance.
• Ensure that seasonal variations are evaluated.
• The sample locations, sampling frequencies and test should be REDUCED to the normal routine pattern based on established PROCEDURES proven during Phase -1 & phase - 2.

Qualification of pharmaceutical water system involves three phases:

Phase -1:

A test period of 2-4 weeks should be spent for monitoring the system intensively. During this period the system should operate continuously without failure or performance deviation.Water cannot be used for pharmaceutical manufacturing in this phase.The following should be included in testing approach.

Phase -2:

A further test period of 2-4 weeks. Sampling scheme will be same as Phase – 1.Water can be used for manufacturing process in this phase. Approach should also

Phase - 3:

Phase 3 runs for one year after satisfactory completion of phase-2.Water can be used for manufacturing process during this process.

Objectives & Features of Phase -3: