Standard Operating Procedure for Inventory Control System in Ocular Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to establish procedures for the control and management of inventory in the manufacturing of ocular dosage forms to ensure accurate tracking, storage, and availability of materials and products.

2) Scope

This SOP applies to all inventory control activities and measures implemented within the facility to manage raw materials, packaging components, and finished products used in the production of ocular dosage forms.

3) Responsibilities

Inventory managers and warehouse personnel are responsible for implementing and maintaining compliance with this SOP. Production and quality control personnel are responsible for providing accurate inventory data and monitoring inventory usage.

4) Procedure

4.1 Receipt and Inspection of Incoming Materials

1. Receive incoming materials and components according to approved procedures and documentation.
2. Inspect received materials for quantity, condition, and compliance with specifications.
3. Label and quarantine materials as necessary pending inspection and testing.

4.2 Storage and Handling

1. Store materials and products in designated areas according to specified storage conditions (e.g., temperature, humidity).
2. Use appropriate storage methods and equipment to prevent contamination, damage, or deterioration.
3. Implement FIFO (First In, First Out) and FEFO (First Expired, First Out) principles for inventory management.

4.3 Inventory Tracking and Control

1. Maintain accurate inventory records using a validated inventory management system.
2. Regularly update inventory records to reflect movements (receipts, issues, transfers) and current stock levels.
3. Conduct periodic physical inventory counts and reconcile discrepancies with inventory records.

4.4 Inventory Disposal and Obsolescence

1. Identify and segregate obsolete or expired materials for proper disposal or return to suppliers.
2. Document and implement procedures for handling and disposing of hazardous or non-conforming materials.
3. Ensure compliance with environmental and regulatory requirements for material disposal.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

1. Inventory management records
2. Material inspection reports
3. Disposal and destruction certificates

7) Reference, if any

Good Manufacturing Practice (GMP) guidelines for pharmaceutical manufacturing

8) SOP Version

Version 1.0