SOP Guide for Pharma

SOP on Raw Material Destruction Procedure

Purpose:

The purpose of this SOP is to establish procedures for the destruction of raw materials that are no longer usable or have expired, to ensure they are disposed of in a safe and environmentally-friendly manner.

Scope:

This SOP applies to all raw materials that are in possession of the facility and need to be destroyed.

Responsibilities:

The Quality Control (QC) department is responsible for the identification, segregation, and documentation of the raw materials that require destruction. The Production department and/or a external disposal contractor is responsible for the actual destruction of the materials in accordance with this SOP.

Procedure:

1. QC will identify any raw material that has expired or is no longer usable and segregate it from other materials. Expired raw materials will have a red tag placed on them, while materials that are no longer usable will be marked with a black tag.

2. The QC department will fill out a Raw Material Destruction Form. The form will include the raw material name, batch number, quantity, reason for destruction, and date.

3. The Production department will be notified about the raw materials that need to be destroyed.

4. The Production department will weigh the materials and record the weight on the Raw Material Destruction Form.

5. The Production

department will transfer the materials to a designated area for destruction.

6. The external disposal contractor will destroy the materials using appropriate methods that adhere to all local, state, and federal regulations, and dispose of them in an environmental-friendly manner.

7. The Production department will record the destruction of the materials on the Raw Material Destruction Form, including the date, time, and method of destruction.

8. The Quality Assurance department will review and approve the Raw Material Destruction Form.

9. The Raw Material Destruction Form will be kept in the company records.

Conclusion:

This SOP ensures that raw materials are destroyed in a safe and environmentally-friendly manner, and that all requirements of local, state, and federal regulations are met.

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