MDI Labeling Guidelines
1) Purpose
The purpose of this SOP is to establish the procedures for labeling metered-dose inhalers (MDIs) to ensure accuracy, compliance with regulatory requirements, and clear communication of product information to end users.
2) Scope
This SOP applies to all personnel involved in the labeling of MDIs at the manufacturing facility, including labeling operators, supervisors, and quality assurance staff.
3) Responsibilities
The responsibilities for this SOP include ensuring correct labeling of MDIs, maintaining labeling equipment, and documenting the labeling process. Specific roles include:
Labeling Operators: Perform the labeling operations as outlined.
Supervisors: Monitor the labeling process and ensure compliance.
Quality Assurance: Inspect and verify the labeling process.
4) Procedure
4.1 Preparation MDI: Metered-Dose Inhaler Labeling records, equipment maintenance logs, and inspection reports should be maintained. Refer to regulatory guidelines from agencies such as the FDA, EMA, and ICH for labeling standards. Version 1.0
4.1.1 Verify the labeling materials against the bill of materials.
4.1.2 Set up the labeling equipment according to the manufacturer’s instructions.
4.1.3 Clean the labeling area to prevent contamination.
4.2 Labeling Process
4.2.1 Load the MDIs onto the labeling machine.
4.2.2 Ensure the correct alignment and application of labels on each MDI.
4.2.3 Perform in-process checks to verify label accuracy, position, and adhesion.
4.3 Quality Checks
4.3.2 Record the inspection results in the labeling logbook.
4.4 Reconciliation
4.4.1 Reconcile the number of labels used with the number of MDIs labeled.
4.4.2 Investigate and document any discrepancies.
4.5 Documentation
4.5.1 Maintain records of labeling batch numbers, dates, and quantities.
4.5.2 Ensure all records are reviewed and approved by quality assurance.
5) Abbreviations, if any
6) Documents, if any
7) Reference, if any
8) SOP Version