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
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 |