Minimum requirements in Warehouse for Oral solid Dosages forms
This article describes about the Minimum requirements in Warehouse for Oral solid Dosages forms as per Regulatory Requirements :
Requirements in Warehouse for Oral solid Dosages forms :
1) Raw Material Store :
a) Unloading area
b) Dedusting area
c) Quarantine area
d) Under Test Area
e) Approved Area
f) Rejection Room
g) Dispensing area
2) Packing Material Store :
Below Areas are Common for among all packing material store areas :
i) Unloading area (Can be Common for all Packing Materials)
ii) Dedusting area (Can be Common for all Packing Materials)
iii) Rejection Room (Can be Common for all Packing Materials)
Primary packing material Area :
a) Quarantine area
b) Under Test Area
c) Approved Area
d) Dispensing area
e) Primary Packing and Printed Packing area shall be in Lock and Key Shall be controlled
Secondary packing material Area :
a) Quarantine area
b) Under Test Area
c) Approved Area
d) Dispensing area
e) Printed Labels shall be in lock and key if any
Tertiary packing material Area :
a) Quarantine area
b) Under Test Area
c) Approved Area
d) Dispensing area
3) Finished Goods Store :
a) Quarantine Area
b) Approved Area
c) Rejected Area
d) Loading/Dispatch Bay
Bare minimum requirement for documents and Practices :
- Area Cleaning Frequency including wall, floor and ceilings
- Racks Cleaning Procedure
- Racks should be installed in store area in such as way that walls shall be cleaned thoroughly.
- Temperature mapping in Raw and Packing material area.
- Hot spot Location Diagram and Hygrometer Location
- 24 Hours AHU/AC/Ventilation running, if any excursion what is handling procedure during Non office Hours. Is there any annunciation system.
- How do you do the Reconciliation/EMRM of Sticker label
- Where do you do the cleaning of Dispensed utensils/ Is dedicated scoops are used for API dispensing
- Vacuum cleaner shall be available for dedusting of Material
- Insectocutors shall be available before the Unloading/Loading bay
- For weighing of materials balance shall be available as per the material availability.
- Material MSDS shall be available in Store area
- Approved Vendor List for RM/PM shall be available
