Lab water purification system PQ

GOOD VALIDATION PRACTICE (cGVP) EQUIPMENT VALIDATION
1

Dear all,
I’m going to do qualification of lab water purification system, and there is a question: should I use a three phases approach while performing PQ as WHO recommends or there is another way of doing PQ for lab water treatment systems?
May be it will be enough to use routine sampling plan, and monitor system for a year? So may be it is ok to skip phase I and phase II in this case?
Thanks

2

What regulatory body or bodies are you governed by? What type of product(s) do you manufacture? These are important questions to help answer your question and should have been know prior to executing the validation. There should have been a plan that spelled out what you are going to do and why.

As far as monitoring goes. You will always have to monitor that is phase three (Continued Process Verification) in the FDA’s guidance for process validation and for good reason. After a year of good data you should be able to scale about your routine monitoring with a study that supports your reasoning to do so.

3

seal,
thank you for reply!
I’m currently in Russia, so there are only ФС 42-2619-97 which is for purified water and ФС 42-2620-97 for water for injections on the other hand, requirements for water for laboratory use are not covered at all.

We are using type 1 water for QC laboratory tests for oral solid dosage forms and for ointments.

For now I’ve already come to decision to do all 3 stages after evaluating risks.

4

[quote=20011]seal,
thank you for reply!
I’m currently in Russia, so there are only ФС 42-2619-97 which is for purified water and ФС 42-2620-97 for water for injections on the other hand, requirements for water for laboratory use are not covered at all.

We are using type 1 water for QC laboratory tests for oral solid dosage forms and for ointments.

For now I’ve already come to decision to do all 3 stages after evaluating risks.[/quote]

Glad to see you made a determination based on a risk assessment. Please don’t forgot to document the risk assessment and keep it with the validation paperwork as it is part of the validation life cycle.