1. Purpose:
The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the raw material inspection procedure and to provide assurance that all raw materials used in the manufacturing process meet the specifications for quality, safety, and effectiveness.
2. Scope:
This procedure applies to all raw materials received by the manufacturing facility, including active pharmaceutical ingredients, excipients, and packaging materials.
3. Responsibilities:
3.1 The Quality Control (QC) department is responsible for the inspection of all raw materials.
3.2 The Warehouse department is responsible for receiving and storing raw materials in accordance with established guidelines.
3.3 The Purchasing department is responsible for ensuring that raw materials are purchased from approved suppliers.
4. Procedure:
4.1 Upon receipt of raw materials, the Warehouse department will verify the accompanying documents against the purchase order and notify the QC department.
4.2 The QC department will perform a visual inspection of the raw materials and verify the identity, quantity, and condition of each item.
4.3 If the raw materials pass the visual inspection, the QC department will perform the required tests according to the specifications established in the product Quality Control Record (QCR).
4.4 If the raw materials fail the visual inspection or tests, the QC department will reject the material and notify the Warehouse and Purchasing departments.
4.5 The QC department will maintain records of all raw materials inspections and test results.
5. Abbreviations: N/A
6. Documents:
6.1 Purchase Orders
6.2 Quality Control Record
6.3 Inspection Checklist
6.4 Material Specification Sheet
7. Reference: N/A
8. SOP Version: x.x
