Warehouse temperature & humidity validation

GOOD VALIDATION PRACTICE (cGVP)
#1

I’m doing a EU GMP program, but the warehouse is not validated.
But I’ve no idea about the validation,
1.how long is acceptable, 8 hours per day for 3 days? Record every 30 minutes?
2.If it is designed for 0~6℃,45%~75%, what is acceptable for max & min? And how do you determin the value?
3.Is it approval to record by man but by machine on line?
4.etc…

Your help will be highly appreciate.

send me a template if possible. THX A LOT AGAIN!

my E-mail: 94roger+000@gmail.com

By the way :Can I do this validation with IQ/OQ/PQ together?

#2

Hi,

1.how long is acceptable, 8 hours per day for 3 days? Record every 30 minutes?
There is no limits specified, its common practice to map the conditions for 7 days, the interval of 30 sounds about right, most loggers allow you to collect more data (e.g. 1 datapoint per 10 min).

2.If it is designed for 0~6℃,45%~75%, what is acceptable for max & min? And how do you determin the value?
You need to stick to the specified limts! Specify a permitted time out of range if you have to and base it on product specification. Otherwise you ned a good written justification for the regulator.

3.Is it approval to record by man but by machine on line?
This question I don’t undertstand, can you specify?

As to you “BTW”, IQ/OQ/PQ are teh validation procedure, so yes, the temperature and humidity validation is part and consists of IQ/OQ/ and PQ.

Regards,
Herbert

#3

Dear Texag,

 Please find answer for query below
 1.how long is acceptable, 8 hours per day for 3 days? Record every 30         minutes? It depends on your validation policy but suggests i should         at       least one week data and also perform temperature monitoring concurently for entire one year and established Kineteic mean temperature.

2.If it is designed for 0~6℃,45%~75%, what is acceptable for max & min? And how do you determin the value?
For relative humidity of warehouse, the acceptance crietria for alert limit is ± 3% RH and action ±5% and for temperature 1.5 °C for alert and 2.5°C for action limit.

3.Is it approval to record by man but by machine on line?
Both monitoring must be initiated by man and by data logger at different points.
Yes, you can do IQ/OQ simaltaneously.

If you have any further query, you can e mail me freely.

www.shahnawaz.sajid@yahoo.com

Regards

[quote=TEXAG]I’m doing a EU GMP program, but the warehouse is not validated.
But I’ve no idea about the validation,
1.how long is acceptable, 8 hours per day for 3 days? Record every 30 minutes?
2.If it is designed for 0~6℃,45%~75%, what is acceptable for max & min? And how do you determin the value?
3.Is it approval to record by man but by machine on line?
4.etc…

Your help will be highly appreciate.

send me a template if possible. THX A LOT AGAIN!

my E-mail: 94roger+000@gmail.com

By the way :Can I do this validation with IQ/OQ/PQ together?[/quote]

#4

I think things are being put out of sequence.

If your warehouse stores regulatory controlled product - then it is that product’s storage requirements, which dictate what conditions must be maintained within the warehouse. If the product has restriction on storage temperature and or humidity, then you must verify through validation that while the product is stored in the warehouse it will be stored within the stipulated temperature and humidity parameters.

So, if the product has no limitations, then there is no validation required. If the product has limitations, then you design you qualifying protocols to show that the product is always maintained within the required parameters.

It is up to you to develop a justification for the time between logging parameters. Experiment - leave the door open or turn the HVAC plant off - then note how long it takes for the system to sense the change. If the system takes 30 minutes to notice a 1% change, and your tolerance is plus or minus 3%. Then you could quite easily justify logging parameters every 15 minutes. What ever you do, document and justify it in your OQ.

Total logging time - log for two complete weeks to cover all dynamic times when the warehouse is in use and all the static times when it is out of use.

If you have a critical product - then you will have to verify the above, during the hottest, driest, coldest and wettest local ambient climatic conditions the warehouse will have to operate in.

This usually means running the two week (minimum) logging exercise, when you are validating and then again once, or twice more. Or however often is required to verify that storage conditions were not compromised by local external ambient weather conditions. You are also required to verify that these runs were actually executed during these adverse climatic conditions. So you need to log the outside climatic ambient conditions.

Alex Kennedy
CEO

#5

now i have a problem about my homework with the logistic subject

could you explain me?

1.what’s the warehouse temperature?

2.could you tell me case study?

3.what kind of the good warehouse?

4.how about warehouse’s temperature process?

if you don’t mind. please send your answer to just_change@hotmail.com

thank you a lot

#6

I live in Fl where its 90 humidity a few times per week and Ive never had a problem. You should be fine.

#7

please find attached a template.

regards,

nagesh
GM CQA

temp mapping.doc (59.5 KB)