Material Inspection and Acceptance – Standard Operating Procedure

1) Purpose

To establish guidelines for inspecting and accepting materials to ensure they meet quality standards and specifications within the pharmaceutical purchase department.

2) Scope

This SOP applies to the inspection and acceptance of materials received by the pharmaceutical purchase department.

3) Responsibilities

Quality Assurance Team: Responsible for inspecting materials.
Purchasing Team: Responsible for coordinating with suppliers and managing acceptance criteria.

4) Procedure

4.1) Inspection Planning:
4.1.1) Plan inspections based on material type, supplier history, and regulatory requirements.
4.1.2) Define inspection methods, sampling plans, and acceptance criteria.

4.2) Pre-Inspection Activities:
4.2.1) Review supplier documentation including certificates of analysis and compliance.
4.2.2) Prepare inspection area and equipment as needed.

4.3) Material Inspection:
4.3.1) Conduct visual and dimensional inspections of materials.
4.3.2) Perform functional or performance tests as applicable.

4.4) Acceptance Decision:
4.4.1) Compare inspection results against acceptance criteria.
4.4.2) Make acceptance or rejection decision based on inspection findings.

4.5) Documentation and Records:
4.5.1) Document inspection results including deviations or non-conformances.
4.5.2) Maintain records of accepted materials and rejections.

4.6) Material Segregation:
4.6.1) Segregate accepted materials from rejected or pending materials.
4.6.2) Ensure proper labeling and storage of segregated materials.

5) Abbreviations, if any

N/A

6) Documents, if any

• Inspection Plans
• Certificates of Analysis
• Inspection Reports
• Material Acceptance Records

7) Reference, if any

Regulatory Guidelines: FDA CFR Part 211.84, ICH Q10
Industry Standards: ISO 13485:2016

8) SOP Version

Version 1.0