MDI Storage Conditions Procedures
1) Purpose
The purpose of this SOP is to define the procedures for the storage of metered-dose inhalers (MDIs) to ensure product stability, integrity, and compliance with regulatory requirements.
2) Scope
This SOP applies to all personnel involved in the storage of MDIs at the manufacturing facility, including warehouse personnel, quality control staff, and production supervisors.
3) Responsibilities
The responsibilities for this SOP include ensuring proper storage conditions, monitoring environmental parameters, and documenting storage activities. Specific roles include:
Warehouse Personnel: Store MDIs according to specified conditions.
Quality Control Staff: Monitor storage conditions and conduct periodic checks.
Production Supervisors: Ensure MDIs are stored in designated areas and comply with storage requirements.
4) Procedure
4.1 Storage Area Designation
4.1.1 Designate specific storage areas for different types of MDIs (e.g., finished products, raw materials).
4.1.2 Ensure storage areas are clean, dry, and free from contaminants.
4.2 Environmental Monitoring
4.2.1 Monitor temperature and humidity levels regularly using calibrated monitoring devices.
4.2.2 Record environmental conditions in the storage logbook.
4.3 Storage Conditions
4.3.1 Store MDIs at specified temperature and humidity conditions as per product
4.3.2 Protect MDIs from light, moisture, and other environmental factors that may affect product quality.
4.4 Handling and Movement
4.4.1 Handle MDIs with care to avoid damage during storage and retrieval.
4.4.2 Follow proper procedures for movement and transfer of MDIs between storage areas.
4.5 Inventory Management
4.5.1 Maintain accurate records of MDI inventory, including batch numbers and expiry dates.
4.5.2 Conduct periodic stock checks and reconcile inventory discrepancies.
4.6 Documentation
4.6.1 Document all storage activities, including temperature logs and inventory records.
4.6.2 Ensure all documentation is reviewed and approved by designated personnel.
5) Abbreviations, if any
MDI: Metered-Dose Inhaler
6) Documents, if any
Storage logs, environmental monitoring records, inventory reports, and temperature mapping studies should be maintained.
7) Reference, if any
Refer to regulatory guidelines from agencies such as the FDA, EMA, and ICH for storage conditions of pharmaceutical products.
8) SOP Version
Version 1.0