Standard Operating Procedure for Data Review and Approval Workflow

Purpose

The purpose of this SOP is to establish procedures for the systematic review and approval of electronic data within the pharmaceutical manufacturing facility. This ensures data accuracy, integrity, and compliance with regulatory requirements.

Scope

This SOP applies to all personnel involved in the generation, processing, and approval of electronic data, including operators, quality control personnel, and quality assurance personnel.

Responsibilities

• Data Owners: Responsible for ensuring the accuracy and completeness of data within their respective areas and initiating the data approval process.
• Quality Control Personnel: Responsible for conducting routine data reviews, documenting observations, and recommending corrective actions when necessary.
• Quality Assurance Personnel: Responsible for the final approval of electronic data, ensuring compliance with regulatory standards and providing oversight of the data review process.

Procedure

1. Identification of Data for Review: Collaborate with data owners to identify electronic data that requires review and approval. Categorize data based on its impact on product quality and regulatory compliance.
2. Data Review Plan: Develop a data review plan outlining the objectives, scope, timelines, resources, and responsibilities for the review process. Include risk assessments and mitigation strategies.
3. Initiation of Data Review: Data owners initiate the data review process by submitting the relevant data for review to the designated quality control personnel.
4. Data Review by Quality Control: Quality control personnel conduct a thorough review of the submitted data, ensuring accuracy, completeness, and compliance with established procedures. Document observations and recommendations for corrective actions if needed.
5. Correction of Identified Issues: If issues are identified during the review process, data owners are responsible for implementing corrective actions promptly. Document the corrective actions taken.
6. Final Approval by Quality Assurance: Quality assurance personnel conduct a final review of the data, including the findings and corrective actions from quality control. Approve the data for further use or request additional actions if necessary.
7. Documentation of Review and Approval: Maintain detailed records of all data review and approval activities, including the review plan, review logs, corrective action records, and final approval records.
8. Communication: Communicate the completion of data review and approval to relevant stakeholders. Provide information on the status of the data and any actions taken to address identified issues.
9. Periodic Review of the Workflow: Conduct periodic reviews of the data review and approval workflow to assess its effectiveness. Address any identified issues and update the procedures accordingly.
10. Training: Provide training to personnel involved in data review and approval activities to ensure a thorough understanding of the procedures and the importance of data integrity.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Data Review Plan
• Data Review Logs
• Corrective Action Records
• Final Approval Records

Reference

ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

SOP Version

Version 1.0