Raw & Primary Packaging Materials, Purpose:
Raw & Primary Packaging Materials, To lay down the procedure for Dispensing of Raw and Primary Packaging Materials used for Manufacturing of Products.
Raw & Primary Packaging Materials, Scope:
This SOP is applicable for the Production Area of General Block of the XX Pharmaceuticals Limited.
Definitions / Abbreviation:
Dispensing: To Prepare and Distribute Medicine.
Responsibilities:
[][]The Roles and Responsibilities are as follows :
Operator
[][]To follow the laid down procedure
Executive, Production
[][]To monitor and check the laid down procedure.
Manager, Production
[][]To implement this correctly
Manager, Quality Assurance
[][]To approve the Document
Annexure:
[][]N/A.
Procedure:
Precautions:
[][]Ensure the cleanliness of Dispensing Area, Weighing Balances, Dispensing Booth, Waste Bin, Pallets before commencing the dispensing activity.
[][]Ensure that Balances are Calibrated and checked for daily accuracy.
[][]Ensure that Dispensing Booth should be switched ‘ON’ 30 minutes before starting dispensing activity.
[][]Ensure that Pressure Differential, Temperature and Relative Humidity of Raw Material (RM) Store, Dispensing and Post Dispensing area are within the specified range. Record details of the same in specified log books.
[][]Executive, Production should obtain Line Clearance from Executive, In-Process Quality Control(IPQC) before dispensing of Batch.
[][]Use separate scoop / spoon for Active Pharmaceutical Ingredient (API) & excipients.
[][]Use hand gloves, mask and eye protector (if required) during weighing and handling of materials.
Dispensing of Raw & Primary Packaging Materials:
[][]Production Personnel shall send the Bill of Material (BOM) along with Batch Manufacturing Record & Batch Packaging Record of respective batch / batches of Product to dispensing unit for dispensing of Raw & Primary Packaging Materials 24 hours in advance.
[][]Upon receipt of BOM Production Personnel shall calculate the quantity of active material for a batch on the basis of potency and other excipient as required.
[][]Operator shall arrange to transfer the required materials from RM & PM Store to ‘Material Staging’ through Air lock corridor.
Material Entry to Dispensing Booth:
[][]Dispensing operator will bring raw materials from ‘Material Staging Area’ to Dispensing Booth through material entry one by one.
[][]Only one raw material shall be dispensed at a time.
[][]Excipients shall be dispensed first and then Active Pharmaceuticals Ingredients (API).
Man Entry to Dispensing Booth:
[][]Dispensing execution team, Executive Quality Compliance, Executive Production and Production Operator will enter in the Dispensing booth through man entry with proper gowning.
[][]Operator shall take the required number of clean and dried Stainless Steel (SS) Scoops/Spatula/ Spoon for dispensing of materials.
Dispensing of Raw Materials :
[][]Obtain Line Clearance approval from Executive, Quality Compliance before starting the dispensing activity.
[][]Operator shall check status labels affixed on the container & simultaneously checked by Executive, Production and Executive, Quality Compliance.
[][]Keep the clean container/drum & polybag in the room.
[][]Fresh double polybags shall be used for holding dispensed materials.
[][]In case of spillage of any raw material during dispensing, collect and weigh the quantity of spillage and destroy.
[][]During weighing of each material, ensure zero on weighing scale before proceeding for dispensing.
[][]Weight the empty Polybag and tare the weight by pressing ‘Tare’ button. Then record in ‘MATERIAL DISPENSING SLIP’
[][]Loose container/ bag should be taken first for dispensing.
[][]Transfer the required quantity of material into tare polybag as per BOM and record the weight in ‘MATERIAL DISPENSING SLIP’.
[][]Remove the issued material of polybag from the weighing balance and keep them on the respective material holding SS Cage Trolley.
[][]After completion of weighing of all materials transfer into the ‘Dispensed Material Staging’ Area & keep the room locked.
[][]In case any quantity of the material is left in original container / bag, affix ‘LOOSE LABEL’ on container/bag.
[][]Keep the Loose bags or containers in ‘Broken Bulk’ room. Send back them to RM Store through Airlock corridor except active material.
[][]At the time of Dispensing, Operator shall fill the details of each dispensed material in the BOM and simultaneously cross checked by Executive, Production and Executive, Quality Compliance.
[][]Dispensing operator shall prepare ‘MATERIAL DISPENSING SLIP’ for each dispensed Materials and which shall be simultaneously checked by Executive, Production and verified by Executive, QA.
[][]Operator shall sign in the column marked as ‘Dispensed by’ in BOM after issue of each and every raw material at the time of dispensing.
[][]Executive, Production shall sign in the column marked as ‘Checked by’ in BOM against each and every raw material.
[][]Executive, Quality Compliance shall sign in the column marked as ‘Checked by’ in BOM against each and every raw material.
[][]In case of any adverse observation, report to Executive, In-Process Quality Compliance (IPQC) for corrective action.
[][]Deface all the labels of empty containers / polybags / boxes / plastic tie with cross marking and transfer them to the scrap area through designated route.
[][]On completion of Dispensing, clean the dispensing area, booth, balances, and utensils as per respective cleaning procedures & record the same in log book. Hang the status label ‘CLEANED’ outside the door.
Dispensing of Primary Packaging Materials :
[][]Obtain Line Clearance approval from Executive, Quality Compliance before starting the dispensing activity.
[][]Operator shall bring required primary packaging materials from ‘Material Staging Area’ and transfer them one by one to dispensing area.
[][]Operator shall check status labels affixed on the container & simultaneously checked by Executive, Production and Executive, Quality Compliance.
[][]In case of spillage of any primary packaging material during dispensing, collect and weigh the quantity of spillage and destroy.
[][]During weighing of each material, ensure zero on weighing scale before proceeding for dispensing.
[][]Weight the empty Polybag and tare the weight by pressing ‘Tare’ button. Then record in ‘MATERIAL DISPENSING SLIP’.
[][]Loose container/ bag should be taken first for dispensing.
[][]Transfer the required quantity of material into tare polybag as per BOM and record the weight in ‘MATERIAL DISPENSING SLIP’.
[][]Remove the issued material from the weighing balance and keep them on the respective material holding SS Cage Trolley.
[][]After completion of weighing of all materials transfer into the ‘Dispensed Material Staging’ Area & keep the room locked.
[][]In case any quantity of the material is left in original container / bag, affix ‘LOOSE LABEL’ on container/bag.
[][]Keep the Loose bags or containers in ‘Broken Bulk’ room. Send back them to PM Store through Airlock corridor.
[][]At the time of Dispensing, Operator shall fill the details of each dispensed material in the BOM and simultaneously cross checked by Executive, Production and Executive, Quality
Assurance
[][]Operator shall prepare ‘MATERIAL DISPENSING SLIP’ for each dispensed Materials and which shall be simultaneously checked by Executive, Production and verified by Executive, QA
[][]Operator shall sign in the column marked as ‘Dispensed by’ in BOM after issue of each and every primary packaging material at the time of dispensing.
[][]Executive, Production shall sign in the column marked as ‘Checked by’ in BOM against each and every primary packaging material.
[][]Executive, Quality Assurance shall sign in the column marked as ‘Checked by’ in BOM against each and every primary packaging material.
[][]In case of any adverse observation, report to Executive, Assurance for corrective action.
[][]Deface all the labels of empty containers / polybags / boxes with cross marking and transfer them to the scrap area through designated route.
[][]On completion of Dispensing, clean the dispensing area, booth and balances as per respective cleaning procedures & record the same in log book. Hang the status label ‘CLEANED’ outside the door.