SOP of Dispensing of Solvent Liquid Materials
To lay down the procedure for dispensing of solvent / liquid materials.
Scope
This SOP is applicable for dispensing of solvent / liquid materials in warehouse at (Pharmaceutical Company Name).
Responsibility
Raw material Store personnel shall be responsible to follow the procedure mentioned in this SOP.
Raw material Store in-charge shall be responsible for implementation of the procedure mentioned in this SOP.
Accountability
Concerned Department Head and QA Head shall be accountable for implementation of this SOP.
Abbreviations and Definitions
IPQA – In-process Quality Assurance
AR.NO. – Analytical Report Number
S.S. – Stainless Steel
WT – Weight
FIFO – First in first out
FEFO – First Expiry first out
RM – Raw Material
D/Booth – Dispensing Booth
QA – Quality Assurance
Procedure
General Condition and Precaution:
Before entering into solvent storage area, inspect quantitatively for nil evidence of solvent leakage / spillage.
All the weighing balances shall be verified & calibrated.
Dispensing area must be cleaned before start of the activity.
Barrel pump must be cleaned.
Ensure to wear secondary gowning, safety boot, hand gloves, nose masks and protective goggle in solvent dispensing area.
Ensure that approved materials to be dispensed.
Loose pack(s) of the liquid materials should take first.
Clean the drums with dry lint free cloth and transfer approved materials along with loose pack (if any) from solvent storage area to dispensing area with hand trolley.
Dispensing Operation:
Dispensing area shall be free from any material of the previous batch.
Check the status of dispensing booth and ensure that ‘CLEANED’ label duly filled and signed is displayed.
Switch ON the light by pressing button on the panel.
Switch ON the RLAF 15 minutes before starting the dispensing activity.
Wait till the differential pressure shows constant pressure drop.
Check available quantity to be issue to facilitate and follow FEFO/FIFO principle.
Before dispensing of the Solvent material, clean the drums with dry lint free cloth.
Approved material shall be shifted one by one for dispensing nearby weighing balance.
Take clean S.S container and place it on the balance to record the tare weight of container on “Dispensed” tag.
Tare the SS container & dispense the net weight of solvent as mentioned in dispensing sheet.
Dispense the solvent with dedicated barrel pump in the clean S.S container placed on the balance.
Remove barrel pump from drum & close the solvent drum tightly with lid. Keep barrel pump into poly bag for further cleaning.
Unload SS container from weighing balance platform slowly to avoid any loss of dispensed quantity of solvent. After completion of dispensing activity, respective area shall be cleaned.
The dispensed qty. duly checked by Production personnel and verified by IPQA personnel & “Dispensed” tag duly filled & signed by respective personals to be affixed on to the respective container.
Remove and dispose off used hand gloves in waste bin.
BMR shall be duly signed by warehouse, production & IPQA personnel during activity.
Dispensing log of solvents shall be maintained refer Annexure-I.
Fill the usage of barrel pump in Barrel Pump usage and cleaning log refer Annexure -II
Note: – Barrel pump is dedicated for each solvent material.
Forms and Records (Annexures)
Dispensing Log of solvents – Annexure-I
Barrel Pump usage and Cleaning log – Annexure-II
Distribution
Master copy – Quality Assurance
Controlled copies – Quality Assurance, Production, Stores.
History
| Date | Revision Number | Reason for Revision |
| – | – | New SOP |
Annexure-I
Equipment ID No.:
Location:
| Date
|
Product Name
|
Batch No | Dispensing time | Dispensed by | Cleaning time | Cleaned by
|
||
| From | To | From | To | |||||
Annexure-II
| Date
|
Product Name
|
Batch No | Barrel Pump usage time | Used by | Barrel Pump cleaning time | Cleaned by
|
||
| From | To | From | To | |||||
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