SOP Guide for Pharma

SOP for Inventory Reconciliation

SOP for Inventory Reconciliation

Inventory Reconciliation – Standard Operating Procedure

1) Purpose

To establish guidelines for reconciling physical inventory counts with inventory records to ensure accuracy and compliance within the inventory management department.

2) Scope

This SOP applies to the process of reconciling inventory counts and records to maintain accurate inventory levels and comply with regulatory requirements.

3) Responsibilities

Inventory Management Team: Responsible for conducting inventory reconciliation activities.
Quality Assurance Team: Responsible for verifying the accuracy and completeness of inventory reconciliation.

4) Procedure

4.1) Cycle Counting:
4.1.1) Conduct regular cycle counts of inventory items based on predefined schedules.
4.1.2) Select inventory items for counting based on criteria such as value, usage frequency, and risk.

4.2) Physical Inventory Count:
4.2.1) Perform physical inventory counts to determine actual quantities of inventory on hand.
4.2.2) Record counts accurately and immediately update inventory records.

4.3) Comparison and Analysis:
4.3.1) Compare physical inventory counts with electronic or manual inventory records.
4.3.2) Investigate discrepancies and identify root causes (e.g., errors in counting, issues with transactions).

4.4) Resolution of Discrepancies:
4.4.1) Implement corrective actions to resolve inventory discrepancies promptly.
4.4.2) Update inventory records and documentation

based on corrected inventory counts.

4.5) Documentation and Records:
4.5.1) Maintain accurate records of inventory reconciliation activities, including cycle count results and discrepancy resolutions.
4.5.2) Document root cause analyses and corrective actions taken for future reference and audits.

5) Abbreviations, if any

N/A

6) Documents, if any

  • Inventory Reconciliation Reports
  • Cycle Count Schedules
  • Discrepancy Investigation Reports
  • Corrective Action Plans and Verification Records

7) Reference, if any

Regulatory Guidelines: FDA CFR Part 211. Inventory Control, ISO 13485:2016
Industry Standards: Good Distribution Practice (GDP)

8) SOP Version

Version 1.0

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