Standard Operating Procedure for Reconciliation of Raw Materials and Packing Materials
1. Purpose:
To lay down a procedure for reconciliation of raw material and packing materials in pharmaceutical warehouse.
2. Scope
The scope this document is to provide the procedure for reconciliation of raw material and packing material in pharmaceutical warehouse.
3. Responsibility
Warehouse personnel: Reconciliation of raw materials and packing materials
Head – warehouse: To ensure the compliance of SOP and supervision of the operation.
4. Definitions
Not applicable
5. Procedure
• When stock of material consumed, reconciliation of material shall be done against material issued and material received and logged in the material management system.
• Material shall be kept in the warehouse with adequate arrangement (batch wise) at respective locations.
• Print the material movement details and stock details from material management system.
• Check the remaining quantity of material of particular batch number from the material management system.
• Computer system stock shall be verified against actual stock. In case when stock is not matching, check for any calculation error and do the required corrections as per good documentation practice. Ensure that there is no impact on any batch produced where material issued. In case of any potential impact, deviation needs to be logged and investigated to identify root cause as well as to perform the product quality risk assessment.
• Balance raw material in the last container shall be weighed and recorded.
• Packing material shall be counted and details shall be recorded. In case of Foils (Aluminum) and Films (PVC, PCV-PVdC, etc.) materials shall be weighed and recorded.
• While reconciliation, ensure that all the logs related to material movements and respective batch numbers are updated in the Material Management System.
• Reconciliation shall be done at the completion of each and every batch number.
• The person responsible for the reconciliation shall record the information in format no. 7.1 and calculate the percentage excess or shortages and record the details in the logbook.
• Acceptable limit for all raw material and packing material, for shortage or excess is given below. [Note: Rationale for deciding the limit shall be based on the quality risk management document of respective organization]
• Shortages for active: NMT 1 % of receipt quantity and for micronized active material NMT 2% of receipt quantity.
• Shortages for Excipient and Packing Material: NMT 3% of receipt quantity. For the material that have tendency of evaporation shall be NMT 5%.
• Excess for active: NMT 1 % of receipt quantity.
• Excess for Excipient and Packing Material: NMT 3% of receipt quantity except bulky materials. For Bulky material Excess shall be NMT 5%. (Example: Starch)
• If the raw and packing material shortage or excess are not within limit then record the details in format No. 7.2.
• For such cases, investigation needs to be done by initiating deviation and investigate the root cause for shortage or excess.
• On the closure of deviation after the completion of investigation for shortage or excess, QA shall approve the format No. 7.2.
• Based on the outcome of an investigation and risk assessment do the rectification of stock details in the material in material management system. After the material of the batch number is totally consumed stock should be zero in material management system.
• Shortages for active: NMT 1 % of receipt quantity and micronized active material NMT 2% of receipt quantity.
• Shortages for Excipient and Packing Material: NMT 3% of receipt quantity. For the material that have tendency of evaporation shall be NMT 5%.
• Excess for active: NMT 1 % of receipt quantity.
• Excess for Excipient and Packing Material: NMT 3% of receipt quantity except bulky materials. For Bulky material Excess shall be NMT 5%. (Example: Starch)
6. Frequency
• At the end of stock for each control number of material.
7. Formats
7.1 Log book for raw materials and packing materials within limit for shortage or excess quantity.
7.2 Format for raw materials and packing materials not within limit for shortage or excess quantity
7.1 Log book for raw materials and packing materials within limit for shortage or excess quantity.
Sr. No.
Item Code
Item Name
Control No.
Received Quantity
Material management system stock
Physical Stock
Excess/ Short (Kg/ Nos.)
Excess/ Short %
Investigation required
Yes / No
Done by
Entered in material management system by
Checked by
Remarks
7.2 Format for raw materials and packing materials not within limit for shortage or excess quantity
Goods Receipt Number
Date of material receipt
Material Name
Material Code
Batch Number
Manufacturer
Received Quantity
Excess or Short % or No. of Receipt quantity
Physical Verification Date
Value
Document Number
Limit: For Raw Material/ Packing Material
Prepared By
Checked by:
Deviation No.
Deviation Close on:
Approved by:
