Standard Operating Procedure for Review and Approval of Process Deviations
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/212/2025 |
| Supersedes | SOP/TAB/212/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 01/03/2026 |
| Effective Date | 06/03/2026 |
| Review Date | 01/03/2027 |
1. Purpose
This SOP outlines the procedure for reviewing and approving process deviations during tablet manufacturing. It ensures that any deviations from approved processes are documented, investigated, and addressed in compliance with GMP and regulatory requirements.
2. Scope
This SOP applies to all deviations from established tablet manufacturing processes, including those related to raw materials, equipment, environmental conditions, and procedures. It covers the review, investigation, approval, and corrective actions associated with process deviations.
3. Responsibilities
- Quality Assurance (QA) Manager: Responsible for overseeing the review and approval of process deviations and ensuring that corrective actions are implemented.
- Production Team: Responsible for identifying, documenting, and reporting process deviations during tablet manufacturing.
- Regulatory Affairs Team: Ensures that the process deviation procedures comply with relevant regulatory guidelines and requirements.
- Process Owners: Responsible for providing input during the investigation of process deviations and suggesting corrective actions.
4. Accountability
The QA Manager is accountable for ensuring that process deviations are reviewed and approved in compliance with GMP and regulatory standards. The Production Team and Process Owners are responsible for identifying deviations and participating in investigations.
5. Procedure
5.1 Identification of Process Deviations
- Identify any deviation from the established tablet manufacturing process, including but not limited to equipment malfunctions, raw material issues, environmental conditions, and procedural non-conformances.
- Document the deviation immediately, including the affected process, batch number, date, and a description of the issue (Annexure-1).
- Notify the QA Manager and Process Owner of the deviation as soon as it is identified.
5.2 Documentation of Process Deviation
- Document the process deviation in the Process Deviation Log (Annexure-2), ensuring that all relevant information is included, such as:
- Batch number and manufacturing date
- Description of the deviation
- Root cause analysis (if known)
- Impact assessment
- Ensure that all entries in the Process Deviation Log are reviewed by the QA team for completeness and accuracy.
5.3 Investigation of Process Deviations
- QA will initiate an investigation into the cause of the process deviation, including reviewing the batch records, equipment logs, and environmental conditions during the affected production run (Annexure-3).
- Collaborate with the Production Team and Process Owners to identify potential root causes, such as equipment malfunction, raw material defects, or human error.
- Use investigation tools such as fishbone diagrams or 5 Whys to determine the root cause of the deviation.
5.4 Corrective Actions
- Once the root cause has been identified, implement corrective actions to address the deviation and prevent recurrence. Corrective actions may include:
- Equipment repairs or recalibrations
- Changes to raw material specifications or suppliers
- Process adjustments or employee retraining
- Document the corrective actions taken in the Corrective Action Report (Annexure-4) and ensure that they are approved by the QA Manager.
5.5 Review and Approval of Process Deviation
- The QA Manager and relevant stakeholders, including the Process Owner, must review the investigation results and the corrective actions taken to address the deviation.
- Approve the deviation and corrective actions if the investigation is thorough, and the corrective actions are deemed sufficient to prevent recurrence (Annexure-5).
- Ensure that the approval is documented, and all records are maintained in accordance with GMP guidelines.
5.6 Communication of Deviation Resolution
- Once the process deviation has been resolved and the corrective actions approved, communicate the resolution to the Production Team and other relevant departments.
- Update the affected batch records and process documentation to reflect the corrective actions taken.
5.7 Documentation and Record Keeping
- Ensure that all documents related to the process deviation, investigation, corrective actions, and approvals are maintained for a minimum of 5 years or as required by regulatory guidelines.
- Store all records in a secure and easily accessible location for future audits and inspections (Annexure-6).
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- GMP: Good Manufacturing Practice
- CAPA: Corrective and Preventive Action
- FDA: Food and Drug Administration
7. Documents
- Process Deviation Log (Annexure-2)
- Root Cause Investigation Report (Annexure-3)
- Corrective Action Report (Annexure-4)
- Process Deviation Approval Log (Annexure-5)
- Process Deviation Records (Annexure-6)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- ISO 9001 – Quality Management Systems
- GMP Guidelines for Pharmaceutical Industry
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 Deviation Log
| Batch Number | Deviation Description | Investigation Date | Resolution |
|---|---|---|---|
| Batch-12345 | Deviation in coating uniformity | 01/03/2026 | Corrective action implemented |
Annexure-2: Process Deviation Investigation Report
| Deviation ID | Root Cause | Corrective Actions | Responsible Person | Completion Date |
|---|---|---|---|---|
| DEV-001 | Incorrect coating solution concentration | Adjusted formulation | Production Lead | 05/03/2026 |
Annexure-3: Corrective Action Report
| Action ID | Action Description | Completion Date |
|---|---|---|
| CAP-001 | Adjusted coating solution concentration | 05/03/2026 |
Annexure-4: Process Deviation Approval Log
| Approval Date | Approved By | Approval Status |
|---|---|---|
| 06/03/2026 | QA Manager | Approved |
Annexure-5: Process Deviation Records
| Batch Number | Deviation Type | Action Taken |
|---|---|---|
| Batch-12345 | Coating Defect | Re-formulated coating solution |
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 procedure for investigating deviations | Clarified responsibilities and actions | QA Head |