Hi All,
I would like to know what is ambient condition in warehouse, and how we can determine at uncontrolled areas?
Is there any reference about it ? I searched in WHO,GMP , But I coulden’t find anything about it.
You need to look PDA technical report 58: Risk management and Temperature-Controlled distribution.
i found the answer
temperature specifications
European Pharmacopoeia
Deep frozen - 15 to 0 °C
Refrigerator 0 to + 6 °C
Cold + 6 to + 15 °C
Room temperature + 15 to + 25 °C
temperature specifications
WHO Good Storage Practice
Normal storage conditions 15 to 25 °C
(up to 30 °C in exceptional cases)
Defined storage conditions
(in accordance with
declaration on container)
Do not store above 30 °C + 2 to + 30 °C
Do not store above 25 °C + 2 to + 25 °C
Do not store above 15 °C + 2 to + 15 °C
Do not store above 8 °C + 2 to + 8 °C
Do not store below 8 °C + 8 to + 25 °C
Protect from moisture £ 60 % rel. humidity under normal storage conditions; to be handed
to the patient in moisture-tight containers
Protect from light To be handed to the patient in light-proof containers