Standard Operating Procedure for Handling and Storing Raw Materials for Nebulizers

1) Purpose

The purpose of this SOP is to establish a systematic approach for the handling and storage of raw materials used in nebulizer production to ensure material integrity, compliance with quality standards, and prevention of contamination.

2) Scope

This SOP applies to all raw materials, including plastics, metals, adhesives, and chemicals, used in the manufacturing process of nebulizers.

3) Responsibilities

Warehouse Team: Receive, handle, and store raw materials as per guidelines.
Production Team: Use raw materials as per production requirements.
Quality Assurance (QA): Inspect and approve incoming materials and ensure proper documentation.

4) Procedure

4.1 Material Receipt

• Inspect all incoming materials for visible damage or contamination upon delivery.
• Verify the materials against the purchase order and supplier’s Certificate of Analysis (COA).
• Label each material with a unique identification code, receipt date, and batch number.
• Segregate materials that do not meet quality standards and label them as “Quarantined.”

4.2 Handling of Raw Materials

• Wear appropriate personal protective equipment (PPE) while handling raw materials.
• Use only approved tools and equipment for material handling to avoid damage or contamination.
• Follow material-specific handling instructions as per the material safety data sheet (MSDS).
• Ensure proper segregation of incompatible materials to prevent chemical reactions or cross-contamination.

4.3 Storage Guidelines

• Store materials in designated storage areas with appropriate labeling for identification.
• Maintain storage conditions such as temperature and humidity as specified in the material’s MSDS or product specifications.
• Arrange materials on racks or pallets to prevent direct contact with floors or walls.
• Implement a First-In-First-Out (FIFO) system for material usage to avoid expiration or degradation.
• Inspect storage areas regularly for signs of pests, moisture, or contamination.

4.4 Dispensing and Transfer

• Before transferring materials to the production area, verify the batch and quantity against the production order.
• Use sanitized transfer containers or trolleys to transport materials to prevent contamination.
• Document the transfer in the Raw Material Dispensing Log.

4.5 Disposal of Non-Conforming Materials

• Segregate non-conforming or expired materials and label them as “Rejected.”
• Dispose of materials as per the environmental and safety regulations outlined in the waste management policy.
• Document the disposal process in the Non-Conforming Material Disposal Log.

5) Abbreviations

• QA: Quality Assurance
• COA: Certificate of Analysis
• MSDS: Material Safety Data Sheet
• FIFO: First-In-First-Out

6) Documents

The following documents should be maintained:

• Raw Material Receipt Log
• Raw Material Dispensing Log
• Non-Conforming Material Disposal Log

7) References

Relevant regulatory guidelines and references include:

• ISO 13485: Medical Devices Quality Management Systems
• Material Safety Data Sheets (MSDS)
• Good Manufacturing Practices (GMP) Guidelines

8) SOP Version

Version: 1.0

Annexure

Annexure Title: Raw Material Receipt Log

Date	Material Name	Batch No.	COA Verified	Inspector Initials	Remarks
DD/MM/YYYY	Material Identifier	Batch Number	Yes/No	Inspector Name	Details of receipt

Annexure Title: Raw Material Dispensing Log

Date	Material Name	Batch No.	Quantity Dispensed	Operator Initials	Remarks
DD/MM/YYYY	Material Identifier	Batch Number	Quantity (kg)	Operator Name	Details of dispensing

Annexure Title: Non-Conforming Material Disposal Log

Date	Material Name	Batch No.	Reason for Disposal	Disposed By	Remarks
DD/MM/YYYY	Material Identifier	Batch Number	Reason	Operator Name	Details of disposal