Ensuring the integrity of healthcare products is critical. This guide outlines the formal procedure for the management, segregation, and disposal of a rejected and damaged medical device within a regulated supply chain, specifically following GDPMD guidelines.
1. Purpose and Scope
The primary objective of this procedure is to define a standardized method for handling any rejected and damaged medical device to prevent accidental distribution and ensure patient safety.
- Applicability: This SOP applies to all medical devices issued by Aika Ceuticals, Lahore.
- Compliance Reference: This procedure aligns with the Guidelines on Good Distribution Practices for Medical Devices (GDPMD).
2. Roles and Responsibilities
Effective management requires clear accountability across departments:
| Role | Responsibility |
| QA Officer | Oversees strict compliance with the SOP and final disposal. |
| Warehouse Incharge | Responsible for documentation, segregation, and seeking director approval. |
| Sales & Marketing | Coordinates with suppliers and distributors for settlements. |
3. Operational Procedure for Damaged Goods
When a medical device is identified as compromised—whether during transportation from a supplier, market returns, or internal handling—the following steps must be taken:
Step 1: Segregation and Identification
The Warehouse Department must immediately isolate the rejected and damaged medical device from saleable inventory. The Store Incharge is responsible for moving these items to a designated "Rejected/Quarantine" area.
Step 2: Quality Assurance Inspection
The Store Incharge submits a formal request to the Quality Assurance (QA) department. QA will investigate the extent of the damage to determine if the device is fit for use or must be officially rejected.
Step 3: Notification and Settlement
If QA confirms the rejection:
- Internal Notification: Details are sent to the Sales, Marketing, and Accounts departments.
- External Coordination: Marketing informs the distributor (for market returns) or the supplier (for procurement damages) to finalize financial settlements.
Step 4: Secure Destruction and Disposal
Once a device is marked for disposal, the following protocol applies:
- The Store Incharge prepares a Medical Device Destruction Form.
- Upon QA approval, the items are incinerated or disposed of.
- Disposal must follow the specific manufacturer guidelines for that finished product.
- All destruction must be supervised by a QA Officer to ensure the device cannot be diverted back into the market.
4. Documentation and Compliance
If goods become damaged or expire while in the possession of the warehouse, the Store Incharge is required to document the incident and update the SOP logs with QA approval. This ensures a transparent audit trail for every rejected and damaged medical D
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