To lay down a procedure for Receipt, Issuance, Storage and Handling of solvent.
This SOP shall be applicable for Receipt, Issuance, Storage and Handling of solvent at Stores Department.
Stores Officer/ Assistant
Head of Department
5.1.1 After receipt of the consignment every document should be examined carefully as per checklist
• Whether the material belongs to us
• Delivery Challan.
• Whether the material is received as per Purchase Order.
• Whether the material received from Approved Vendors.
• Cenvat Copy / Bill of Entry.
• Mfg. COA.
5.1.2 Before unloading, store person shall inspect the vehicle for cleanliness and allow the vehicle for unloading.
5.1.3 Unload the drums in solvent room and clean the drums by clean dry cloth damped with potable water.
5.1.4 Store person shall check the Item Name, Batch No. and Mfg. Name on each drum and note down the gross weight, tare weight and net weight in physical verification record.
5.1.5 If Mfg. COA is not received with the consignment, store person shall immediately inform to purchase dept.
5.1.6 Store person shall transfer solvent drums in solvent room under lock and key and shall be opened only for dispensing, sampling and cleaning purpose.
5.1.7 Give the acknowledgement to the transporter and record all the details in Raw Material Inward Register.
5.1.8 If any discrepancy found immediately, store person shall prepare the discrepancy note and record all the details of the consignment in physically verification record, for which the discrepancy is found.
5.1.9 Store person shall prepare the GRN in SAP system in MIGO and take the print out of GRN in duplicate copy and send it to Quality Control department along with the Mfg. COA.
5.1.10 Ensure that Quality Control department acknowledges the receipt of GRN in the GRN register.
5.1.11 Enter the GRN detail in respective Bin Cards and affix QUARANTINE label on each drum.
5.1.12 Sampling of solvent shall be done by Q.C. After sampling, Q.C. Dept shall put sticker as “Q.C sampled” on QUARANTINE labels of sampled containers.
5.1.13 After completion of analysis, Q.C person shall affix the “APPROVED” or “REJECTED” label on the “QUARANTINE” label.
5.1.14 Sample quantity of each consignment shall be deducted in respective bin cards by store person immediately.
5.1.15 Store person shall segregate the “Approved” barrel with the “Quarantine” barrel with yellow nylon rope.
• Solvent should issue only in dedicated stainless steel container.
• Solvent should dispense through hand operated barrel pump and pipe.
5.2.1 Store person shall wear safety protective equipment like hand gloves, safety shoes, safety goggle and safety nose mask while dispensing of solvent.
5.2.2 Store person & QA person shall check the label on each barrel for details of Approved Label, Mfg. date and Exp. Date, Material Name and Analytical Report Number.
5.2.3 Remove the solvent with help of stainless steel dedicated barrel pump in cleaned, closed, tared SS container at solvent room.
5.2.3 Clean the stainless steel container with clean dry lint free cloth at receiving way before transfer into the dispensing room.
5.2.4 Place the stainless steel container on weighing balance and adjust the weight as per required qty. and transfer the balance qty. if any in a small closed stainless steel container to original drum
5.2.5 Close the stainless steel container properly with lid, after required quantity of material is dispensed.
5.2.6 Store person shall note down the gross weight and net weight in dispensing slip and sign it with date and countersigned by QA person.
5.2.7 Enter the details of A.R. No. and Net quantity in raw material requisition sheet/ Bill of Material.
5.2.8 Store person shall attach dispensing slip on stainless steel container and Affix the “Under Use”/ Loose quantity label on original barrel. Transfer the barrel into the solvent room
5.2.9 Store person shall keep back all safety protective equipment's to its original place and transfer the barrel pump and pipe to washing area.
5.2.10 Store person shall transfer stainless steel container to dispensed material storage area.
5.3.1 Store the solvent barrel in solvent room only under lock and key.
5.3.2 Store the each type solvent in solvent room item wise & GRN wise.
5.3.3 If material is rejected by QC, segregate the drum from other drums in a solvent room & tied with red color nylon rope. Check rejected label should be affix on each drums.
5.3.4 Close the solvent containers tightly after dispensing / sampling.
5.4.1 Electrical equipment for handling flammable solvent should be of flameproof type.
5.4.2 Flammable solvent drums should be moved using drum trolley and should never be dropped or rolled over the floor.
5.4.3 Whenever it is necessary to transfer solvent from drum into smaller closed containers, appropriate handling equipment should be provided to enable the operation to be carried out with minimum risk of spillage and exposure.
5.4.4 While opening drums and other containers care must be taken for any excess pressure in the form of vapour.
5.4.5 Good ventilation is essential in rooms where flammable solvent are handled to prevent accumulation of flammable vapours.
5.4.6 Personnel handling flammable solvent should wear necessary personal protective equipment including respiratory protective equipment to minimize the risk of exposure.
6.1 SOP – Standard operating procedure
6.2 COA – Certificate of analysis
6.3 QC – Quality control
6.4 QA – Quality assurance
6.5 SS – Stainless steel
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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