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