Standard Operating Procedure for QA Oversight During Process Validation Studies
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/207/2025 |
| Supersedes | SOP/TAB/207/2022 |
| Page No. | Page 1 of 7 |
| Issue Date | 01/03/2026 |
| Effective Date | 06/03/2026 |
| Review Date | 01/03/2027 |
1. Purpose
This SOP outlines the process by which the QA team provides oversight during the process validation studies. The goal is to ensure that the manufacturing processes are adequately validated, that the process consistently produces products meeting quality standards, and that all regulatory requirements are met.
2. Scope
This SOP applies to all process validation activities conducted within the tablet manufacturing department. It includes QA involvement during the design, execution, and documentation of process validation studies for raw materials, in-process materials, and finished tablet products.
3. Responsibilities
- Quality Assurance (QA) Manager: Responsible for overseeing the process validation process and ensuring that all activities are conducted in compliance with internal and regulatory standards.
- Process Validation Team: Responsible for designing and conducting process validation studies, while ensuring that QA oversight is incorporated into the study.
- Production Team: Responsible for executing the process steps as defined in the validation protocol and ensuring accurate documentation throughout the process.
- Regulatory Affairs: Ensures that the validation process adheres to regulatory guidelines such as ICH, USP, and FDA requirements.
4. Accountability
The QA Manager is accountable for ensuring that QA oversight is integrated into every stage of the process validation. The Process Validation Team is responsible for executing the validation protocols and collaborating with QA for documentation and compliance verification.
5. Procedure
5.1 Preparation for Process Validation
- Ensure that a formal process validation protocol is developed, outlining the process steps, validation parameters, equipment requirements, and acceptance criteria (Annexure-1).
- QA must review and approve the process validation protocol before any validation activities begin.
- Ensure that all necessary equipment, raw materials, and personnel are available and ready for the process validation study.
- Confirm that the appropriate stability study and batch records are in place for the validation batches to be used in the study (Annexure-2).
5.2 QA Oversight During Execution of Process Validation
- During process validation execution, QA must oversee the process to ensure that all steps are followed as per the validation protocol.
- Monitor the execution of the process validation study and ensure that all equipment is calibrated and working properly.
- Verify that the critical process parameters, such as temperature, pressure, and mixing speed, are within the validated ranges during each batch of the study.
- Ensure that sampling is done at appropriate time points and that samples are sent to the QC laboratory for analysis (Annexure-3).
- Document any deviations observed during the execution of the process and ensure corrective actions are taken immediately (Annexure-4).
5.3 Data Collection and Review
- QA must ensure that all process validation data is collected, recorded, and analyzed according to the established protocol.
- Ensure that the data reflects the actual process conditions and that any deviations are properly investigated and documented.
- Once the validation batches are completed, review the collected data for completeness and accuracy. Confirm that all test results meet the predefined acceptance criteria (Annexure-5).
- If any data points fall outside of the acceptable limits, work with the Process Validation Team to assess whether the batch needs to be reprocessed or discarded.
5.4 Final Approval of Process Validation
- Once the validation data has been reviewed, QA must give the final approval for the process validation report (Annexure-6).
- If the process validation is successful and all criteria are met, QA will approve the process and release it for routine production use.
- If the validation fails, QA and the Process Validation Team will work together to identify corrective actions and perform additional validation runs if necessary.
- Ensure that the final validation report, including all test results, deviations, and corrective actions, is signed off by the QA Manager.
5.5 Documentation and Record Keeping
- Ensure that all process validation records, including protocols, data, reports, and deviation logs, are properly documented and archived according to regulatory requirements.
- Ensure that all records are signed, dated, and stored in a secure and accessible location for future audits and inspections (Annexure-7).
- Review the process validation records periodically to ensure compliance with the original protocol and regulatory guidelines.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- QC: Quality Control
- CAPA: Corrective and Preventive Action
- FDA: Food and Drug Administration
- ICH: International Council for Harmonisation
- USP: United States Pharmacopeia
7. Documents
- Process Validation Protocol (Annexure-1)
- Stability Study and Batch Records (Annexure-2)
- Sampling Log (Annexure-3)
- Deviation Report (Annexure-4)
- Process Validation Report (Annexure-5)
- Final Validation Approval (Annexure-6)
- Process Validation Records Archive (Annexure-7)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- USP <1225> – Validation of Analytical Methods
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Process Validation Protocol
| Batch Number | Validation Steps | Acceptance Criteria | Test Method |
|---|---|---|---|
| Batch-12345 | Process Step 1, Process Step 2 | Yield > 95% | Dissolution, Assay |
Annexure-2: Stability and Batch Records
| Batch Number | Test Parameter | Test Results | Storage Conditions |
|---|---|---|---|
| Batch-12345 | Assay | 99.8% | 25°C ± 2°C, 60% RH |
Annexure-3: Sampling Log
| Sample ID | Sample Date | Sampled By | Test Method |
|---|---|---|---|
| Sample-123 | 01/03/2026 | John Doe | Dissolution |
Annexure-4: Deviation Report
| Deviation ID | Deviation Description | Root Cause | Corrective Action |
|---|---|---|---|
| DEV-001 | Deviation in temperature | Equipment malfunction | Recalibrate equipment |
Annexure-5: Process Validation Report
| Batch Number | Validation Results | Approval Status |
|---|---|---|
| Batch-12345 | Pass | Approved |
Annexure-6: Final Validation Approval
| Approval ID | Approved By | Approval Date |
|---|---|---|
| VAL-001 | Jane Smith | 01/04/2026 |
Annexure-7: Process Validation Records Archive
| Document | File Location | Retention Period |
|---|---|---|
| Process Validation Report | Document Archive A | 5 years |
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 | Updated process validation protocol | Added new validation parameters | QA Head |