1. PURPOSE
2. SCOPE
3. RESPONSIBILITIES
4. MATERIAL & EQUIPMENT
5. PROCEDURE
Storage Condition |
Description |
Room
Temperature |
20 to 25°C (Excursion permitted
between 15-30°C) |
Cool
Condition |
8
to 15°C |
(Refrigerator)
Cold Condition |
2
to 8°C |
Freezer
Storage |
-25
to -10°C |
Section |
Area |
Temperature |
Relative Humidity |
Tablet
/ Bolus |
Manufacturing |
15 - 30°C |
NMT 60 % |
Compression & Blistering |
15 - 30°C |
NMT 50 % |
|
Packaging |
15 - 30°C |
NMT 60 % |
|
Powder |
Manufacturing to Filling |
15 - 30°C |
NMT 45 % |
Packaging |
15 - 30°C |
NMT 60 % |
|
Capsule |
Manufacturing to Blistering |
15 - 30°C |
NMT 45 % |
Packaging |
15 - 30°C |
NMT 60 % |
|
Syrup
/ Drench |
Manufacturing
to Packaging |
15 - 30°C |
NMT 60 % |
Injectable
/Aerosol |
Manufacturing
to Filling |
15 - 25°C |
NMT 60 % |
Packaging |
15 - 30°C |
NMT 60 % |
|
Warehouse |
RM
/ FG Warehouse |
15 - 30°C |
NMT 60 % |
Dispensing Areas |
15 - 30°C |
NMT 45 % |
|
QC/Micro |
Retained Samples Area |
15 - 30°C |
NMT 70 % |
QC Hall |
15 - 30°C |
NMT 70% |