MDI Packaging Procedures
1) Purpose
The purpose of this SOP is to define the packaging procedures for metered-dose inhalers (MDIs) to ensure product integrity, safety, and compliance with regulatory requirements.
2) Scope
This SOP applies to all personnel involved in the packaging of MDIs at the manufacturing facility, including packaging operators, supervisors, and quality assurance staff.
3) Responsibilities
The responsibilities for this SOP include ensuring proper packaging of MDIs, maintaining packaging equipment, and documenting the packaging process. Specific roles include:
Packaging Operators: Execute the packaging steps as outlined.
Supervisors: Oversee the packaging process and ensure compliance.
Quality Assurance: Inspect and document the packaging process.
4) Procedure
4.1 Preparation
4.1.1 Verify the packaging materials against the bill of materials.
4.1.2 Clean and set up the packaging equipment as per the standard operating procedure.
4.2 Packaging Process
4.2.1 Load the MDIs onto the packaging line.
4.2.2 Ensure the correct labeling of each MDI unit.
4.2.3 Pack the labeled MDIs into the primary packaging (e.g., boxes).
4.2.4 Conduct in-process checks to ensure packaging accuracy.
4.3 Secondary Packaging
4.3.1 Transfer
4.3.2 Pack the primary packages into shipping boxes or cartons.
4.3.3 Label the secondary packages with batch information and handling instructions.
4.4 Final Inspection
4.4.1 Inspect the packaged MDIs for any defects or inconsistencies.
4.4.2 Record the inspection results in the packaging log.
4.5 Storage and Handling
4.5.1 Store the packaged MDIs in designated storage areas.
4.5.2 Ensure proper handling and transportation conditions to maintain product integrity.
5) Abbreviations, if any
MDI: Metered-Dose Inhaler
6) Documents, if any
Packaging records, equipment maintenance logs, and inspection reports should be maintained.
7) Reference, if any
Refer to regulatory guidelines from agencies such as the FDA, EMA, and ICH for packaging standards.
8) SOP Version
Version 1.0
