Standard Operating Procedure for Data Validation and Verification

Purpose

The purpose of this SOP is to establish procedures for the systematic validation and verification of electronic data within the pharmaceutical manufacturing facility. This ensures the accuracy, reliability, and integrity of data used for decision-making and regulatory compliance.

Scope

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

Responsibilities

• Data Owners: Responsible for identifying critical data elements, defining validation criteria, and ensuring the accuracy of data within their respective areas.
• Quality Control Personnel: Responsible for executing routine data validation activities, ensuring compliance with established procedures, and reporting any deviations or discrepancies.
• Quality Assurance Personnel: Responsible for conducting periodic reviews and audits of data validation processes to ensure compliance with regulatory requirements.

Procedure

1. Identification of Critical Data Elements: Collaborate with data owners to identify critical data elements that require validation. Prioritize data elements based on their impact on product quality and regulatory compliance.
2. Definition of Validation Criteria: Clearly define validation criteria for each identified data element. This may include accuracy, completeness, consistency, and timeliness. Document the validation criteria in a standardized format.
3. Validation Plan: Develop a validation plan outlining the objectives, scope, timelines, resources, and responsibilities for the validation process. Include risk assessments and mitigation strategies.
4. Data Sampling: Select representative samples of data for validation, ensuring coverage of different batches, production shifts, or relevant time periods. The sampling plan should be statistically justified.
5. Validation Testing: Execute validation tests according to the defined criteria. This may involve comparison with reference data, calculation of derived values, or verification against predefined limits. Document the testing procedures and results.
6. Documentation of Deviations: In case of deviations or discrepancies identified during validation testing, document the details, including the nature of the deviation, its impact on data integrity, and proposed corrective actions.
7. Validation Report: Compile a validation report summarizing the testing procedures, results, and any deviations. Include conclusions and recommendations for process improvements if applicable.
8. Periodic Review: Conduct periodic reviews of validation reports to assess the ongoing effectiveness of validation processes. Address any identified issues and update the procedures accordingly.
9. Training: Provide training to personnel involved in data validation 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 Validation Criteria Document
• Validation Plan
• Validation Test Records
• Validation Report

Reference

ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

SOP Version

Version 1.0