Standard Operating Procedure for Packaging and Labeling Nebulizer Units
1) Purpose
The purpose of this SOP is to outline the standardized procedures for packaging and labeling nebulizer units to ensure product integrity, compliance with regulatory requirements, and proper identification.
2) Scope
This SOP applies to the packaging and labeling processes for all nebulizer units, including manual and automated operations in the production facility.
3) Responsibilities
Operators: Execute packaging and labeling operations as per the defined procedure.
Quality Assurance (QA): Inspect and approve the packaged and labeled units.
Maintenance Team: Ensure the smooth functioning of packaging and labeling equipment.
4) Procedure
4.1 Pre-Packaging Preparation
- Ensure that all nebulizer units are visually inspected and meet the quality standards before packaging.
- Verify that the packaging materials (e.g., boxes, pouches, seals) match the specifications in the batch packaging record (BPR).
- Check the labeling templates for accuracy, including batch number, expiration date, and regulatory symbols.
- Calibrate and test packaging and labeling machines to ensure proper operation.
4.2 Packaging Process
- Load the nebulizer units onto the packaging line, ensuring correct orientation and alignment.
- Feed the packaging materials into the machine and adjust settings for size and type of packaging.
- Seal the packages using the designated method (e.g., heat sealing,
4.3 Labeling Process
- Ensure the label printer is loaded with the correct label stock and programmed with accurate information.
- Apply labels to the designated areas on the packaging, ensuring alignment and readability.
- Verify the legibility and accuracy of labels, including batch number, manufacturing date, and expiration date.
- Perform random sampling during labeling to check for misaligned or missing labels.
4.4 Post-Packaging and Labeling Activities
- Segregate and label non-conforming packages for rework or disposal.
- Store the packaged units in designated areas with proper identification tags.
- Document all packaging and labeling activities in the Batch Packaging Record (BPR).
4.5 Safety Precautions
- Always wear personal protective equipment (PPE), including gloves and safety glasses, during operations.
- Ensure that all packaging materials are handled in a clean and contamination-free environment.
- Follow lockout/tagout (LOTO) procedures for troubleshooting or machine adjustments.
5) Abbreviations
- QA: Quality Assurance
- BPR: Batch Packaging Record
- PPE: Personal Protective Equipment
6) Documents
The following documents should be maintained:
- Batch Packaging Record (BPR)
- Labeling Log
- Packaging Defect Report
7) References
Relevant regulatory guidelines and references include:
- ISO 13485: Medical Devices Quality Management Systems
- Good Manufacturing Practices (GMP) Guidelines
8) SOP Version
Version: 1.0
Annexure
Annexure Title: Batch Packaging Record (BPR)
| Date | Batch No. | Packaging Material | Quantity Packaged | Operator Initials | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Identifier | Material Description | Units Packaged | Operator Name | Details of operation |
Annexure Title: Labeling Log
| Date | Batch No. | Label Template | Quantity Labeled | QA Approval | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Identifier | Template Name | Units Labeled | QA Name | Details of labeling |
Annexure Title: Packaging Defect Report
| Date | Batch No. | Defect Type | Defective Units | Operator Initials | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Identifier | Defect Description | Number of Units | Operator Name | Details of defect |
