Standard Operating Procedure for Ensuring Data Integrity in Tablet Manufacturing Processes
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/189/2025 |
| Supersedes | SOP/TAB/189/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 01/03/2026 |
| Effective Date | 06/03/2026 |
| Review Date | 01/03/2027 |
1. Purpose
To establish procedures that ensure data integrity throughout the tablet manufacturing process, including accurate recording, maintenance, and validation of all data generated during production, testing, and packaging.
2. Scope
This SOP applies to all departments involved in tablet manufacturing, including production, quality control, packaging, and quality assurance. It ensures that all data related to manufacturing processes, including raw material testing, process monitoring, and final product inspection, is accurate, reliable, and traceable.
3. Responsibilities
- Quality Assurance (QA): Responsible for overseeing the implementation of this SOP, ensuring the integrity of data across all stages of tablet manufacturing, and conducting audits to verify compliance.
- Production Team: Responsible for ensuring that all process data, including machine settings, production quantities, and environmental conditions, is accurately recorded and verified.
- Quality Control (QC): Responsible for maintaining accurate records of raw material testing, in-process testing, and final product testing, and ensuring that data integrity is maintained during all testing activities.
- IT Department: Responsible for ensuring the security, backup, and accessibility of electronic data systems used in tablet manufacturing.
4. Accountability
The QA Manager is accountable for ensuring that all data generated during tablet manufacturing processes is accurate, reliable, and traceable, and for ensuring that all relevant personnel adhere to the data integrity policies set forth in this SOP.
5. Procedure
5.1 Data Collection and Recording
- All data related to the tablet manufacturing process, including production parameters, testing results, and environmental conditions, must be recorded accurately in the designated logbooks or electronic systems (Annexure-1).
- Ensure that all data entries are legible, signed, and dated by the responsible personnel. In the case of electronic data, ensure that the systems used have secure login protocols to track user activity.
- In the case of electronic records, ensure that the system has a validated audit trail feature that records all changes made to the data, including who made the change, when it was made, and the reason for the change.
5.2 Data Validation
- Data must be validated for accuracy and completeness at each stage of the tablet manufacturing process. This includes validating raw material test results, in-process testing data, and final product testing data (Annexure-2).
- Ensure that validation checks are conducted regularly and that any discrepancies are investigated and corrected. For electronic systems, ensure that appropriate validation protocols (such as 21 CFR Part 11 compliance) are followed.
- For manual records, perform periodic checks to ensure that the data is correctly recorded and in compliance with GMP standards.
5.3 Data Security and Access Control
- Ensure that all data, whether electronic or paper-based, is securely stored and protected from unauthorized access, modification, or deletion.
- Implement access controls to restrict access to sensitive data. Only authorized personnel should have the ability to modify or delete data records. Maintain logs of all data access activities.
- Ensure that electronic records are backed up regularly, and maintain a disaster recovery plan in case of system failure or data loss.
5.4 Data Integrity Audits
- Conduct regular audits of data records to verify compliance with data integrity policies. Audits should include both electronic and paper records, and should cover all areas where data is generated or stored (e.g., production, QC, packaging) (Annexure-3).
- Audits should be conducted by personnel who are independent of the data collection process to ensure impartiality. Audit findings should be documented and reviewed by senior management.
- Any deviations from data integrity policies must be immediately addressed, and corrective actions should be implemented to prevent recurrence.
5.5 Corrective and Preventive Actions (CAPA)
- If any data integrity issues are identified during audits or through regular monitoring, a CAPA plan must be developed and implemented (Annexure-4).
- The CAPA plan should include an investigation into the root cause of the data integrity issue, corrective actions to address the immediate issue, and preventive actions to prevent similar issues in the future.
- Document all CAPA activities, including the root cause analysis, corrective actions, preventive actions, and verification of effectiveness.
5.6 Training and Awareness
- All personnel involved in data recording, validation, or monitoring should receive training on the importance of data integrity and the procedures outlined in this SOP.
- Training should be conducted initially and on a regular basis to ensure that personnel are aware of the latest data integrity requirements and best practices.
- Document all training activities, including the date, content, and participants (Annexure-5).
5.7 Documentation and Record Keeping
- Ensure that all records related to data integrity, including audit reports, CAPA plans, training records, and validation logs, are maintained for the required retention period (minimum of five years or as required by regulatory authorities).
- Ensure that all records are easily accessible for review during internal audits and regulatory inspections.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- QC: Quality Control
- CAPA: Corrective and Preventive Action
- FDA: Food and Drug Administration
7. Documents
- Data Integrity Log (Annexure-1)
- Validation Report (Annexure-2)
- Data Integrity Audit Log (Annexure-3)
- CAPA Report (Annexure-4)
- Training Record Log (Annexure-5)
8. References
- 21 CFR Part 11 – Electronic Records; Electronic Signatures (US FDA)
- ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- ISO 9001 – Quality Management Systems
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Data Integrity Log
| Record ID | Data Type | Entered By | Date | Comments |
|---|---|---|---|---|
| REC-001 | Production Data | John Doe | 01/03/2026 | Data entered manually in system |
Annexure-2: Validation Report
| Validation ID | System Tested | Validation Performed By | Date | Outcome |
|---|---|---|---|---|
| VAL-001 | Production System | Jane Smith | 01/03/2026 | Validation Passed |
Annexure-3: Data Integrity Audit Log
| Audit ID | Audit Date | Auditor | Findings | Corrective Action |
|---|---|---|---|---|
| AUD-001 | 01/03/2026 | John Doe | No discrepancies found | N/A |
Annexure-4: CAPA Report
| CAPA ID | Issue | Corrective Action | Responsible Person | Completion Date |
|---|---|---|---|---|
| CAPA-001 | Data discrepancy | Retraining of staff on data entry | Jane Smith | 01/03/2026 |
Annexure-5: Training Record Log
| Training ID | Training Date | Trainer | Participants | Topic |
|---|---|---|---|---|
| TRN-001 | 01/03/2026 | John Doe | All Production Staff | Data Integrity Procedures |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP Creation | QA Head |
| 01/02/2025 | 2.0 | Enhanced data integrity practices | Improved data validation and audit procedures | QA Head |