SOP of Dispensing of Solvent Liquid Materials

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  

Annexure-I

Equipment ID No.:

Location:

Annexure-II

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