Standard operating procedure for receipt,issuance,storage & handling of solvents.
1.0 Purpose
The purpose of this SOP is to develop a standard procedure for receipt,issuance,storage & handling of solvents.
2.0 Scope
This SOP is applicable for the procedure used for receipt, issuance,storage & handling of solvents in pharmaceutical industries.
3.0 Responsibility
3.1 Dispensing operator is responsible for cleaning the solvent drums & dispensing activities.
3.2 The QC assistant is responsible for sampling the solvents.
3.3 The Store Manager is responsible for ensuring the implementation of this SOP.
3.4 Q.A. Officer monitors the compliance of this SOP.
4.0 Procedure
4.1 Receipt
4.1.1 When a consignment vehicle reaches the facility the store supervisor shall verify all the required documents i.e COA,material list,delivered from approved vendor, manufacturing & expiry date.
4.1.2 When all the requirements are fulfilled the solvent drums shall be offloaded in the solvent cleaning area.
4.1.3 The store supervisor shall examine all the drums physically for any damage & if any damage found immediately report to the supply chain department.
4.1.4 The dispensing operator shall clean all the solvent drums with lint free cloth soaked in purified water.
4.1.5 After cleaning, the store personnel shall check the product name,mfg & expiry date & gross weight of all the solvent drums.
4.1.6 Give receiving to the vehicle driver,enter all the required data i.e GRN in SAP/manual system as per in-house SOP.
4.1.7 Shift all the solvent drums to the solvent quarantine & affix the Quarantine label.
4.1.8 Send the list of received solvent drums to QC department for sampling.
4.1.9 QC assistant shall sample all the containers as per sampling SOP and affix QC sampled label to each drum.
4.1.10 Affix released label to the drums if QC passed the solvent barrels & transfer in release area & affix rejected label if QC failed the solvent drum & transfer in rejected area.
4.2 Issuance
4.2.1 Take line clearance from store & QA offer for issuance/dispensing of the solvent.
4.2.2 Bring solvent drum to the solvent dispensing area having a calibrated weighing balance.
4.2.3 Ensure that the proper system for ventilation is operational in the dispensing area.
4.2.4 The dispensing staff shall wear protective gloves,shoes,and masks.
4.2.5 Place washed cleaned stainless steel container over weighing balance, check its tare weight & mention it on the dispensing label.
4.2.6 Open the lid of the solvent barrel & transfer the solvent with the help of a stainless steel manual barrel transfer pump or through the auto suction transfer pump.
4.2.7 Weight the required quantity of solvent as per manufacturing order (MO) & verify the gross weight by store & QA officer.(Apply conversation factors from Liters to kilograms if required)
4.2.8 Remove the transfer pump & close the lid of the solvent barrel.
4.2.9 Apply loose drum status label to the barrel from which solvent is dispensed & transfer it to its original location.
4.2.10 Close the lid of container in which solvent is dispensed & affix the dispensing label having following information
Product Name,Batch number,lot number, quantity.This container shall be transferred to the dispensed solvent room.
4.2.11 Place back all the safety equipment & transfer pump to its original location.
4.2 12 Note the activity in the dispensing logbook.
4.3 Storage
4.3.1 Store the solvent barrels in the solvent room under lock & key control.
4.3.2 Store all the solvent drums product wise with proper released label.
4.3.3 Place rejected drums in separate rejection area.
4.3.4 Ensure proper closing of the lid of the solvent drum after dispensing or sampling.
Record the activity in logbook.
4.4 Handling
4.4.1 All the electrical equipment used in the solvent room must be flameproof.
4.4.2 Never drop or roll the flame-able solvent drums on the floor,always use a drum transfer trolley.
4.4.3 Solvent dispensing should be done after wearing proper PPEs.
Flammable Solvent must be handled in a well ventilated area.
5.0 Abbreviations
5.1 SOP: Standard Operating Procedure
5.2 QA: Quality Assurance
5.3 MO Manufacturing Order
5.4 PPEs Personal Protective equipment