Dear forum Experts,
In our sister concern we have find one difficult situation during the WHO GMP audit preparation regarding Purified water system. We are going to face the WHO GMP audit within 20 days.
There purified water system is not having any Phase-I & Phase-II validations but it was having Purified water quality review for three consecutive years. Now concern is how can we manage this situation during the audits? Can we perform the Phase-I & Phase-II validation with close monitoring? But we do not have sufficient time to finish in this time. We have 3 years Quality review. Can we consider it as a Phase-III validation as it was evaluated seasonel variations?
If auditors ask can we give the commitment to perform the Phase-I & Phase-II validation now?
Our purfied water system is having online Temperature, Conductivity, Turbidity and free residual chlorine monitoring and documented same.
We are looking valuable suggestions from our experts to avoid the observations.
Thanks in advance.
Pulla Reddy Karnati.
If you have a 3 years Quality review- It might certainly contain all the reports that are necessary for evaluation of
-Feed water characteristics-Normal & Seasonal
-Feed water regular counts (Microbial)
-Purified water counts (Microbial)
-Storage conditions
-Tank passivation and start-up conditions
-UV light source and its log book about intensity
-Regular sampling conditions and limits (Alert & Action limits)
-Installation plan
-Commissioning plan
-Qualification plan both (IQ & OQ) -(Phase 1)
-Operational plan (Phase-2 & Phase 3)
-Monitoring since 1.5 years (Phase-3-Continuous monitoring)
-Change controls
-Material certifications
-Calibration sheets
-Boroscopy, weld and contact material certifications.
-Valves and seal material certifications
-Measures to prevent rouge and Maintenance procedures.
-Spares and Material qualification.
-Distribution loop qualification and monitoring speeds and circulation capacities and Head capacity of Pumps.
-P&I Diagrams & Dead legs and Drain valves.
-Outlet monitoring or waste water monitoring
-Temperature & Conductivity reports.
-Hardness of water report and its silicon content in water(Initial testing reports)
-Scheme of Generation of Purified water and Material balance considerations including selection based on quality of feed and quality of output water based on compendial recommendations.
All these might have had respective place in your Quality review.
Dig them out and compile them as per the Guidance and make a report.
Be honest with WHO auditors and show your quality review you have.
I do not recommend you to cook a report and sign on back dates.
If you have a Quality review report containing above basic list, your case might be considered.
Regards