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View Full Version : Validation of water system in API (Active Pharmaceutical Ingredients) unit


tighara
29th August 2009, 02:04 AM
Hello Friends,

My self Pramod I am Working as a quality Assurance officer in API unit(pharma), If any one have information regarding how to make water validation then please help me out. I am looking for guideline for water validation in pharma.






Best Regards,


Pramod

Jennifer Kirley
31st August 2009, 07:41 AM
Welcome to the Cove :bigwave: Now that it is Monday morning, I will bring this up again.

Does anyone have some advice for Pramod?

BradM
31st August 2009, 08:02 AM
Hello Friends,

My self Pramod I am Working as a quality Assurance officer in API unit(pharma), If any one have information regarding how to make water validation then please help me out. I am looking for guideline for water validation in pharma.






Best Regards,


Pramod

Hello, Pramod!:bigwave:

What exactly are you trying to validate? Is this a Water for Injection system? Is the water being made currently qualify as WFI?

harry
31st August 2009, 08:20 AM
To my knowledge, these kind of systems are usually supplied by specialist who design, install and finally validate the output before handing over to the user. You should have technical manuals. specs, etc to fall back to.

alex.Kennedy
3rd September 2009, 11:48 AM
Hi
First you need to sort out what water you are validating.