Standard Operating Procedure for Raw Material Storage

1) Purpose

The purpose of this SOP is to establish procedures for the proper storage of raw materials to ensure their quality and integrity are maintained until they are used in the manufacturing process.

2) Scope

This SOP applies to all personnel involved in the storage of raw materials for the production of intramuscular, subcutaneous, and intravenous injection products.

3) Responsibilities

The responsibilities of this SOP include:
– Warehouse Personnel: Proper storage and handling of raw materials.
– Quality Assurance (QA) Department: Inspecting and approving storage conditions and ensuring compliance with SOP.

4) Procedure

4.1 Receipt and Inspection of Raw Materials
4.1.1 Upon receipt, inspect raw materials for damage and verify against purchase orders and specifications.
4.1.2 Record the receipt of raw materials in the inventory system and assign a unique identification number.
4.2 Storage Conditions
4.2.1 Store raw materials in designated areas based on their storage requirements (e.g., temperature, humidity).
4.2.2 Ensure that storage areas are clean, organized, and free from contamination.
4.2.3 Maintain appropriate environmental conditions as specified for each type of raw material (e.g., refrigerated, ambient).
4.3 Inventory Management
4.3.1 Implement a first-expiry-first-out (FEFO) system to ensure materials with the earliest expiration dates are used first.
4.3.2 Conduct regular inventory checks to verify quantities and conditions of stored materials.
4.3.3 Record any discrepancies or damages in the inventory system and report to QA.
4.4 Labeling and Segregation
4.4.1 Label all raw materials with the unique identification number, date of receipt, and expiration date.
4.4.2 Segregate raw materials by type, status (quarantine, released, rejected), and any specific storage conditions.
4.4.3 Store rejected or expired materials in a separate area to prevent accidental use.
4.5 Handling and Safety
4.5.1 Follow proper handling procedures to avoid contamination, damage, or degradation of raw materials.
4.5.2 Use appropriate personal protective equipment (PPE) when handling raw materials.
4.5.3 Ensure material safety data sheets (MSDS) are accessible and understood by all relevant personnel.

5) Abbreviations, if any

– QA: Quality Assurance
– FEFO: First-Expiry-First-Out
– PPE: Personal Protective Equipment
– MSDS: Material Safety Data Sheets

6) Documents, if any

– Inventory Records
– Inspection Reports
– Material Safety Data Sheets (MSDS)

7) Reference, if any

– Good Manufacturing Practices (GMP) Guidelines
– International Organization for Standardization (ISO) Standards

8) SOP Version

Version 1.0