SOP of Dispensing of Solvent Liquid Materials
To lay down the procedure for dispensing of solvent / liquid materials.
This SOP is applicable for dispensing of solvent / liquid materials in warehouse at (Pharmaceutical Company Name).
- 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.
- 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
- 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.
- General Condition and Precaution:
- 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
- Master copy – Quality Assurance
- Controlled copies – Quality Assurance, Production, Stores.
Reason for Revision
Equipment ID No.:
|Batch No||Dispensing time||Dispensed by||Cleaning time||Cleaned by|
|Batch No||Barrel Pump usage time||Used by||Barrel Pump cleaning time||Cleaned by|
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