Standard Operating Procedure Vendor Data Integrity

Purpose

The purpose of this SOP is to establish procedures for ensuring the integrity of data received from vendors within the pharmaceutical manufacturing facility. This includes data related to raw materials, components, and services supplied by external vendors.

Scope

This SOP applies to all personnel involved in the procurement, quality control, and quality assurance of materials and services provided by external vendors.

Responsibilities

• Procurement Department: Responsible for establishing and maintaining a vendor qualification process, including the assessment of vendors’ data integrity practices.
• Quality Control Personnel: Responsible for conducting inspections and testing of materials received from vendors, ensuring compliance with data integrity standards and specifications.
• Quality Assurance Personnel: Responsible for overseeing the overall vendor data integrity program, conducting audits, and ensuring compliance with regulatory requirements.

Procedure

1. Vendor Qualification: Establish a vendor qualification process that includes an assessment of the vendor’s data integrity practices. Ensure that vendors adhere to applicable regulatory requirements and industry standards.
2. Vendor Agreement: Include clauses related to data integrity in vendor agreements. Clearly outline expectations regarding the accuracy, completeness, and security of data provided by the vendor.
3. Data Verification: Verify the accuracy and completeness of data provided by vendors, including certificates of analysis, batch records, and other relevant documents. Cross-check data against established specifications and standards.
4. Audit Trail Review: Conduct periodic reviews of audit trails associated with data provided by vendors. Ensure that audit trails are secure, complete, and provide a reliable record of data changes.
5. Secure Data Transmission: Implement secure methods for the transmission of data between the vendor and the pharmaceutical facility. Utilize encryption and other measures to protect data integrity during transit.
6. Data Storage: Establish secure data storage practices for vendor-supplied information. Ensure that data is stored in a controlled environment with appropriate access controls and backup procedures.
7. Periodic Vendor Audits: Conduct periodic audits of vendors to assess their data integrity practices. Verify that vendors have adequate controls in place to ensure the accuracy and reliability of the data they provide.
8. Non-Conformance Handling: Develop procedures for handling instances of data non-conformance from vendors. Clearly define the steps to be taken, including communication with the vendor and initiation of corrective actions.
9. Documentation: Maintain detailed records of vendor qualifications, data verification activities, audit trail reviews, and any corrective actions taken. Ensure that documentation is easily retrievable for regulatory inspections.
10. Training: Provide training to personnel involved in vendor management on data integrity principles, regulatory requirements, and the importance of accurate and reliable data from vendors.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Vendor Qualification Records
• Vendor Agreements
• Data Verification Logs
• Audit Trail Review Reports
• Vendor Audit Reports
• Non-Conformance Records

Reference

ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

SOP Version

Version 1.0