SOP for Reconciliation of raw and packaging materials stock

1.0 OBJECTIVE
To ensure the procedure of physical stock checking and reconciliation of raw and packaging material stock at the time of verification.

2.0 SCOPE
This procedure is applicable for physical stock checking and reconciliation of raw and packaging materials stock.

3.0 RESPONSIBILITY
3.1 Warehouse officer shall be responsible to follow the laid down procedure.
3.2 Manager, Warehouse shall be responsible for effective implementation of procedure.

4.0 ACCOUNTABILITY
4.1 Manager, Warehouse.

5.0 PRECAUTIONS
5.1 Ensure the calibration due date of weighing balance before physical stock checking of raw and packaging materials.
5.2 Ensure that shortage & excess of materials are within specified limit against each consignment respectively. 

6.0 PROCEDURE
6.1 Instruction for physical stock checking of raw and packaging materials
6.1.1 Warehouse officer shall check physical stock of raw and packaging materials (active & inactive raw materials / primary & printed packaging materials) within first week of every month which materials used for production in last month.
6.2 Physical stock taking procedure
6.2.1 According to material issue record from Inventory Management System (IMS), Warehouse officer shall check physical stock of selected raw and packaging materials. Materials are to be carried on floor on the day of checking.
6.2.2 In presence of warehouse officer operator shall weigh materials (raw material, foils and films) on the balance one after another and count intact printed packaging materials as per pack size and loose materials as per stock return label. Warehouse officer shall record observed data in Physical Stock Checking Sheet (FWH/041).After completion of physical stock checking, warehouse officer confirmed the procedure with checked by signature & date on the stock checking sheet.
6.2.3 After completion of checking of warehouse stock, warehouse officer will contact with concern production officer for checking of materials kept (if any) in dispensing area. Dispensing operator will weigh (raw material, foils and films) and count printed packaging materials in presence of production officer. Production officer send stock report to warehouse with production officer checked by signature & date. Warehouse Officer shall combine production stock with warehouse stock.
6.2.4 Warehouse, Manager to find out the variation in quantity between physical stock and Inventory stock. As per stock variation adjust the excess/shortage quantity, if next lot is not available in warehouse, otherwise materials will be adjusted after completion of running A.R.
6.3 Instruction for reconciliation of raw and packaging material stock
6.3.1 Ensure that shortage & excess of materials are within below mentioned specified limit against each consignment respectively.
6.3.1.1 Active Pharmaceutical Ingredients  0.5 %.
6.3.1.2 Inactive raw materials  1.0 %.
6.3.1.3 Pregelatinized Starch and Microcrystalline Cellulose up to + 4.0%
6.3.1.4 Foil/PVDC and Printed packaging materials  5.0 %.
6.4 Reconciliation of raw materials stock after dispensing
6.4.1 Production officer shall reconcile all issuance against total receipts at the end of running A.R No. and prepare “Shortage/Excess Information Form (FWH/009)”.
6.4.2 Production officer shall inform to QA officer for verification and approval of Shortage/Excess quantity through “Shortage/Excess Information Form” After QA approval, Production officer shall send duly signed “Shortage/Excess Information Form “to warehouse dept.
6.4.3 After receipt of Shortage/Excess Information Form, warehouse officer shall check the calculated percentage of shortage/excess materials in the Information Form against receipt quantity of each A.R. If the calculated percentage is within specified limit, he shall prepare ‘Stock Adjustment Memo’ for excess of material (FWH/033) /shortage of material (FWH/022) and get the approval from Unit Head.
6.4.4 In case of any discrepancy beyond specified limit Production officer shall inform to Manager Warehouse, Head of Production and QA for further action and do not dispense balance quantity from that consignment till the discrepancy is resolved.
6.4.5 QA, Production and Warehouse shall jointly investigate the matter as per failure investigation procedure. (SOP No.: QA010)
6.4.6 After receipt of approval from QA, warehouse officer shall prepare ‘Stock Adjustment Memo’ for excess of material (FWH/033) /shortage of material (FWH/022) and get the approval from Unit Head.
6.4.7 Warehouse officer shall update stock in “Inventory Management System (IMS)”
6.5 Reconciliation of packing materials stock after dispensing
6.5.1 Follow the step No. 6.4.1 to 6.4.6

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