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, adhesive application).
• Inspect the sealed packages at regular intervals for defects, such as improper sealing or damage.

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