Material Specification and Quality Requirements – Standard Operating Procedure

1) Purpose

To define the process for establishing material specifications and quality requirements to ensure consistency and compliance in procurement.

2) Scope

This SOP applies to the specification and quality requirements for materials purchased by the pharmaceutical purchase department.

3) Responsibilities

Quality Assurance Team: Responsible for defining material specifications and quality standards.
Purchasing Team: Responsible for ensuring procurement meets specified requirements.

4) Procedure

4.1) Material Specification Development:
4.1.1) Define material attributes such as chemical composition, physical properties, and packaging requirements.
4.1.2) Establish acceptance criteria based on regulatory standards and internal quality policies.

4.2) Supplier Communication:
4.2.1) Communicate material specifications to suppliers during the sourcing process.
4.2.2) Obtain confirmation of supplier capability to meet specifications.

4.3) Quality Agreement:
4.3.1) Establish quality agreements with suppliers outlining responsibilities and expectations.
4.3.2) Include specifications and quality assurance measures in the agreement.

4.4) Compliance Verification:
4.4.1) Verify supplier compliance with agreed-upon specifications through audits and inspections.
4.4.2) Document verification results and deviations.

5) Abbreviations, if any

N/A

6) Documents, if any

• Material Specification Sheets
• Quality Agreements
• Supplier Confirmation Records

7) Reference, if any

Regulatory Guidelines: FDA CFR Part 211.84, ICH Q7
Industry Standards: ISO 13485:2016

8) SOP Version

Version 1.0