I am writing a water system PQ for a labscale water system, I am a aware of a phased approach to PQ for full size water systems; i.e. Phase 1: monitor the performance of each water system component and overall performance; Phase 2: monitor performance of water system and ‘tweak’; update SOPs on sanitisation and cleaning etc. Phase 3: continued routine monitoring on system.
Can somebody tell me where this phased approach comes from; what regulation or guideline; can’t find it in any of the EU guidelines…
[quote=Niamh]I am writing a water system PQ for a labscale water system, I am a aware of a phased approach to PQ for full size water systems; i.e. Phase 1: monitor the performance of each water system component and overall performance; Phase 2: monitor performance of water system and ‘tweak’; update SOPs on sanitisation and cleaning etc. Phase 3: continued routine monitoring on system.
Can somebody tell me where this phased approach comes from; what regulation or guideline; can’t find it in any of the EU guidelines…
thanks, Niamh[/quote]
Dear Niamh,
You can refer WHO TRS-937 and FDA guidelines , where you will find it.
[quote=Niamh]I am writing a water system PQ for a labscale water system, I am a aware of a phased approach to PQ for full size water systems; i.e. Phase 1: monitor the performance of each water system component and overall performance; Phase 2: monitor performance of water system and ‘tweak’; update SOPs on sanitisation and cleaning etc. Phase 3: continued routine monitoring on system.
Can somebody tell me where this phased approach comes from; what regulation or guideline; can’t find it in any of the EU guidelines…
thanks, Niamh[/quote]
Phased qualification of water sytem is mentioned in Annexure 3 of WHO TRS 929 , if you require I shall send it to your mail ID send your contact
water ssytem design mentioned in WHO TRS 929 annex 3 , where you will find all the detail sregarding design requirements , installation and operation checks and performance requirements ( Philosophy )
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