Final Product Inspection Procedures for MDIs

1) Purpose

The purpose of this SOP is to establish procedures for conducting final product inspection of metered-dose inhalers (MDIs) to ensure compliance with quality standards, specifications, and regulatory requirements before release.

2) Scope

This SOP applies to all personnel involved in final product inspection activities within the MDI production facility, including quality control inspectors, production supervisors, and packaging personnel.

3) Responsibilities

The responsibilities for this SOP include performing final product inspections, verifying compliance with specifications, documenting inspection results, and authorizing product release. Specific roles include:
Quality Control Inspectors: Conduct detailed inspections of finished MDIs against defined criteria.
Production Supervisors: Oversee final inspection processes and ensure timely product release.
Packaging Personnel: Verify packaging integrity and labeling accuracy before final inspection.

4) Procedure

4.1 Inspection Criteria
4.1.1 Define inspection criteria based on product specifications, batch records, and regulatory requirements.
4.1.2 Include visual inspection, functional testing, and compliance with labeling requirements in inspection criteria.
4.2 Inspection Process
4.2.1 Inspect finished MDIs according to approved inspection plans and procedures.
4.2.2 Use calibrated equipment and validated methods for testing and verification.
4.3 Non-Conformance Handling
4.3.1 Identify and document any non-conformances or deviations observed during inspection.
4.3.2 Initiate investigation, corrective actions, and preventive actions (CAPA) for non-conforming products.
4.4 Documentation and Release
4.4.1 Record inspection results, including test methods, equipment used, and inspection outcomes.
4.4.2 Authorize release of conforming MDIs for packaging and distribution.

5) Abbreviations, if any

MDI: Metered-Dose Inhaler
SOP: Standard Operating Procedure
CAPA: Corrective and Preventive Actions

6) Documents, if any

Final product inspection protocols, inspection records, non-conformance reports, and release certificates should be maintained.

7) Reference, if any

Refer to regulatory guidelines from agencies such as the FDA, EMA, and ICH for final product inspection requirements in pharmaceutical manufacturing.

8) SOP Version

Version 1.0