Equipment Revalidation - Refrigerated rooms (2°C – 8°C)

[fheatherly]

I am the QA/RA Manager for a pharmaceutical distribution company. We distribute directly for the manufacturer, therefore they come and audit us prior to doing business with us as well as annually.
We recently had an audit by a potential client. The final report came to us and the auditor wrote a finding that said:
"The validation program is not stringent enough to ensure absolute level of equipment performance.
Validation of refrigerated rooms (2°C – 8°C) did not include partial and loaded chamber during temperature mapping. The empty chamber mapping shows temperature uniformity but does not represent normal usage.
The Master Validation Policy currently requires periodic revalidation of storage areas every five (5) years.
Periodic revalidation is undertaken to ensure that these areas remain capable of achieving the intended results and revalidation in a five (5) year cycle is too long to confirm that the refrigerated rooms are functioning in accordance with specifications.
Changes may occur gradually even if the refrigerated rooms are operated according to established methods. Similarly, equipment wear may also cause some gradual changes."

Our Master Validation Plan states that the areas will be revalidated every 5 years. Which we had a validation consultant come in 4 years ago and help us us get the temperature controlled areas validation the first time and he said that every 5 years is sufficient. We have a continuous monitoring system that would detect any "gradual changes". We check the monitoring system charts on a daily basis and then do an annual trending analysis, plus we have a reduntant monitoring system through our security system that would also detect any changes. We also have a preventive maintenance program that checks the refrigerator units each quarter.

We conducted the validations in an empty chamber because that is the worse case scenerio. Does anyone see a problem with this and if so why?

Does anyone know if this is too long or where I can find specific requirements on when equipment should be revalidated?

We are audited by each of our 30 clients on an annual basis and this is the first time that anyone has questioned the 5 year plan or the empty chamber validation.

[Jim Wynne]

Originally Posted by fheatherly

Validation of refrigerated rooms (2°C – 8°C) did not include partial and loaded chamber during temperature mapping. The empty chamber mapping shows temperature uniformity but does not represent normal usage.

Unless the auditor can reference some accepted standard to support these contentions, then there should be no issue. If the customer has specific standards or expectations and you don't meet them, then it becomes a matter of negotiation.

Originally Posted by fheatherly

Our Master Validation Plan states that the areas will be revalidated every 5 years. Which we had a validation consultant come in 4 years ago and help us us get the temperature controlled areas validation the first time and he said that every 5 years is sufficient. We have a continuous monitoring system that would detect any "gradual changes". We check the monitoring system charts on a daily basis and then do an annual trending analysis, plus we have a reduntant monitoring system through our security system that would also detect any changes. We also have a preventive maintenance program that checks the refrigerator units each quarter.

Do you have 5 years worth of data? The general method for establishing such intervals is to start with relatively short spans of time, expanding them only when the data supports such a decision. It will be difficult to argue 5-year efficacy if you don't have 5 years worth of data.

Originally Posted by fheatherly

We are audited by each of our 30 clients on an annual basis and this is the first time that anyone has questioned the 5 year plan or the empty chamber validation.

It doesn't make any difference what all the other customers say if one particular potential customer doesn't like it. Your issue is with that potential customer, and you need data if you want to prove him wrong.