Dear Aii,
Can anybody please tell me the frequency of sampling of water during validation phase? Can we decrease the frequency of sampling in 2nd phase in comparision of 1st phase?
If yes, then what is the reference?
Thanks & regards
Divan Singh
Pulse
[COLOR=“black”]Phase 1. A test period of 2–4 weeks should be spent monitoring the system intensively. During this period the system should operate continuously without failure / performance deviation. The following procedures should be included in the testing approach.
• Undertake chemical and microbiological testing in accordance with a defined
plan.
• Sample the incoming feed-water to verify its quality.
• Sample after each step in the purification process daily.
• Sample at each point of use and at other defined sampling points daily.
• Develop appropriate operating ranges.
• Develop and finalize operating, cleaning, sanitizing and maintenance
procedures.
• Demonstrate production and delivery of product water of the required
quality and quantity.
• Use and refine the standard operating procedures (SOPs) for operation,
maintenance, sanitization and troubleshooting.
• Verify provisional alert and action levels.
• Develop and refine the test-failure procedure.
Phase 2. A further test period of 2–4 weeks should be spent carrying out further intensive monitoring while deploying all the refined SOPs after the satisfactory completion of phase 1. The sampling scheme should be generally the same as in phase 1. Water can be used for manufacturing purposes during this phase.
The approach should also:
— demonstrate consistent operation within established ranges; and
— demonstrate consistent production and delivery of water of the required quantity and quality when the system is operated in accordance with the SOPs.[/color]
Hi All,
Very Good explanation based on WHO technical reports for approaches. Just to add that " One can define the sampling frequency & No. of samples based on the risk assessment & scientific rational based Justification in Performance qualification protocol". There may be the cases where the Phase-1 sampling may differ from the phase-2 sampling but this difference should be evaluated, recorded & justified. It is well acceptable by the agencies as well. Please go through the requirements by FDA guidance “Inspection Guides > High Purity Water Systems (7/93)”.
We can challenge the agencies if we have the logic & Justification. The point is you have to convince more…sometime it becomes difficult or leads to un-necessary delays / debates.
Happy Reading !