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.