Standard Operating Procedure for Handling and Storage of Raw Materials
1) Purpose
The purpose of this SOP is to ensure proper handling and storage of raw materials used in the manufacturing of dental dosage forms to maintain their quality and prevent contamination.
2) Scope
This SOP applies to all raw materials used in the manufacturing of dental pastes, gels, and mouthwashes within the pharmaceutical industry.
3) Responsibilities
The Warehouse Department is responsible for the proper handling and storage of raw materials. The Quality Assurance (QA) Department is responsible for monitoring and ensuring compliance with the SOP.
4) Procedure
4.1 Receipt of Raw Materials
4.1.1 Verify the identity and quality of raw materials upon receipt.
4.1.2 Check the packaging for integrity and any signs of damage.
4.1.3 Record the receipt of raw materials in the inventory log.
4.2 Handling
4.2.1 Use appropriate personal protective equipment (PPE) when handling raw materials.
4.2.2 Follow specific handling instructions provided by the manufacturer.
4.2.3 Minimize exposure to air, light, and moisture to preserve material integrity.
4.3 Storage
4.3.1 Store raw materials in designated areas with appropriate environmental controls (e.g., temperature, humidity).
4.3.2 Label all storage containers clearly with the material name, batch number, and expiration date.
4.3.3 Rotate stock using the First-In-First-Out (FIFO) method to ensure older materials are used first.
4.4 Documentation
4.4.1 Maintain records of all raw materials, including receipt, handling, and storage details.
4.4.2 Conduct regular inventory checks to ensure accuracy and compliance.
5) Abbreviations, if any
PPE – Personal Protective Equipment
FIFO – First-In-First-Out
6) Documents, if any
Inventory Log
Material Receipt Records
7) Reference, if any
Current Good Manufacturing Practices (cGMP) guidelines
8) SOP Version
Version 1.0
