Standard Operating Procedure for Data Integrity in Equipment Use
1) Purpose
The purpose of this SOP is to establish procedures for ensuring data integrity in the use of equipment during the manufacturing of dental dosage forms, including pastes, gels, and mouthwashes. The goal is to maintain accurate, complete, and reliable records throughout the equipment lifecycle to support product quality and regulatory compliance.
2) Scope
This SOP applies to all equipment and instrumentation used in pharmaceutical manufacturing processes for dental dosage forms. It includes procedures for data entry, recording, review, storage, and retention to prevent data integrity issues.
3) Responsibilities
The Quality Assurance (QA) Department is responsible for overseeing and enforcing data integrity practices. The Engineering and Production Departments are responsible for ensuring proper data recording and compliance with data integrity procedures. All personnel involved in equipment operation and data recording are responsible for adhering to these procedures and reporting any deviations promptly.
4) Procedure
4.1 Data Entry and Recording
4.1.1 Use validated electronic systems or approved paper-based forms for recording equipment operation data, including parameters, settings, and observations.
4.1.2 Record data promptly and accurately at the time of observation or operation, ensuring entries are attributable, legible, contemporaneous, original, and accurate (ALCOA).
4.1.3 Use electronic signatures
4.2 Review and Approval
4.2.1 Review recorded data for completeness, accuracy, and compliance with predefined specifications and procedures.
4.2.2 Obtain appropriate approvals for recorded data from authorized personnel, ensuring that any corrections or amendments are documented with an explanation and justification.
4.2.3 Implement controls to prevent unauthorized access, modification, or deletion of recorded data.
4.3 Data Storage and Retention
4.3.1 Store electronic records in secure, validated systems with access controls to prevent unauthorized alteration or deletion.
4.3.2 Archive and retain records in accordance with established retention schedules and regulatory requirements.
4.3.3 Ensure the integrity and accessibility of archived records throughout their retention period.
4.4 Data Integrity Checks
4.4.1 Perform regular data integrity checks and audits to verify the accuracy, completeness, and consistency of recorded data.
4.4.2 Investigate and resolve any discrepancies or anomalies identified during data integrity checks, documenting investigation findings and corrective actions taken.
4.5 Training and Documentation
4.5.1 Provide training to personnel involved in equipment operation and data recording on data integrity principles, procedures, and regulatory requirements.
4.5.2 Maintain documented procedures and work instructions for data entry, recording, review, and data integrity practices.
5) Abbreviations, if any
SOP – Standard Operating Procedure
QA – Quality Assurance
ALCOA – Attributable, Legible, Contemporaneous, Original, Accurate
6) Documents, if any
Data Integrity Policy
Data Entry Forms or Electronic Systems
Data Review and Approval Records
Data Integrity Audit Reports
Training Records
7) Reference, if any
Good Documentation Practices (GDP)
Regulatory guidelines for data integrity in pharmaceutical manufacturing
Industry best practices for electronic record keeping and data integrity
8) SOP Version
Version 1.0
