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Dispensing of Solvent Liquid Materials

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

 

Checked by

 

Remarks

 

From To From To
                     

 

Annexure-II

Date

 

Product Name

 

Batch No Barrel Pump usage time Used by Barrel Pump cleaning time Cleaned by

 

Checked by

 

Remarks

 

From To From To
                     

 

 

 

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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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