Inventory Management Procedures for MDI Production
1) Purpose
The purpose of this SOP is to establish procedures for inventory control in metered-dose inhaler (MDI) production to ensure accurate tracking, storage, and management of materials and finished products.
2) Scope
This SOP applies to all inventory management activities within the MDI production facility, including raw materials, intermediates, packaging materials, and finished products.
3) Responsibilities
The responsibilities for this SOP include maintaining inventory accuracy, conducting regular counts, ensuring proper storage conditions, and documenting all inventory transactions.
4) Procedure
4.1 Inventory Tracking
4.1.1 Implement an inventory management system to track the receipt, storage, and usage of materials and finished products.
4.1.2 Assign unique identification numbers or barcodes to all inventory items for accurate tracking and traceability.
4.2 Receiving Materials
4.2.1 Verify the quantity and quality of incoming materials against purchase orders and specifications upon receipt.
4.2.2 Record all received materials in the inventory management system and update stock levels accordingly.
4.3 Storage Conditions
4.3.1 Store materials and finished products under appropriate conditions to maintain their quality and integrity, following specified storage requirements such as temperature, humidity, and light exposure.
4.3.2 Segregate materials based on their status (e.g., quarantined, approved, rejected) and compatibility to prevent cross-contamination.
4.4 Inventory Issuance and Usage
4.4.1 Implement procedures for
4.4.2 Monitor inventory usage regularly to detect discrepancies and take corrective actions if necessary.
4.5 Inventory Counts
4.5.1 Conduct regular physical inventory counts (e.g., monthly, quarterly) to verify actual stock levels against recorded levels in the inventory management system.
4.5.2 Investigate and resolve any discrepancies identified during inventory counts, documenting the findings and corrective actions taken.
4.6 Disposal of Obsolete or Expired Inventory
4.6.1 Identify and segregate obsolete, expired, or damaged materials and products for proper disposal according to regulatory requirements and company policies.
4.6.2 Update the inventory management system to reflect the disposal and adjust stock levels accordingly.
4.7 Documentation and Records
4.7.1 Maintain accurate records of all inventory transactions, including receipts, issuances, returns, and disposals.
4.7.2 Document any deviations from SOPs related to inventory control and implement corrective actions as necessary.
5) Abbreviations, if any
MDI: Metered-Dose Inhaler
SOP: Standard Operating Procedure
6) Documents, if any
Inventory management system records, receiving logs, inventory count sheets, disposal records, and corrective action reports should be maintained as part of the inventory control process.
7) Reference, if any
Refer to inventory management guidelines from regulatory agencies, industry standards (e.g., GMP), and internal quality management procedures.
8) SOP Version
Version 1.0
