Temp mapping in warehouse

GOOD MANUFACTURING PRACTICE (cGMP)
1

Dear All,

Is the Temp mapping in warehouse is mandatory requirement for regulatory point of view??
If yes then what is the reason?

Regards

Prashant Mhetre

2

Dear Prashant,
Its mandatory
Generally, we keep the temperature guage at one place in the warehouse and will record the value displayed by the guage once or twice in a day. In this scenario, how can you assure that the value recorded by you is the ultimate representative of the temperature in all locations of your storage area? For this purpose, do the temperature mapping, identify the hottest point and keep the guage in that position.

regards
Veerraju

3

Good day Prashant

I am afraid that there are now defined requirements for the validation of drug storage climatic storage conditions.

It has been found that controlled drugs have been damaged by being held in environments that are outside the temperature limits for their safe storage. Either in the production area (obviously as finished product) or in stores, warehouses, during transportation, clinics and retail outlets. This has led to several product recalls.

Validation throughout what is called the COLD CHAIN is now mandatory for drugs with specific storage requirements. For drugs with no specified storage conditions, you are required to validate that your own specific storage conditions will maintain the drugs, the drug packaging and all attendant documentation in the conditions specified, in the User Requirements, for the finished product.

Warehouse validation therefor depends on what condition are specified as required for the drugs, drug containers and all required documentation to be stores safely. Although termed Cold Chain it applies equally to drugs that may be adversely affected by cold conditions.

Alex Kennedy

4

Hi,

Yes it is required, as confirmed by Alex & Ramyaraj. Short term temperature excursions can also be included in validation. Low temperature effect on the drugs, being affected adversely is also important to define specific storage condition & during transportation.

Deepa

5

Yes, it is required in regulated point view.