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

1. 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.
2. Document the deviation immediately, including the affected process, batch number, date, and a description of the issue (Annexure-1).
3. Notify the QA Manager and Process Owner of the deviation as soon as it is identified.

5.2 Documentation of Process Deviation

1. 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
2. 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

1. 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).
2. Collaborate with the Production Team and Process Owners to identify potential root causes, such as equipment malfunction, raw material defects, or human error.
3. Use investigation tools such as fishbone diagrams or 5 Whys to determine the root cause of the deviation.

5.4 Corrective Actions

1. 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
2. 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

1. The QA Manager and relevant stakeholders, including the Process Owner, must review the investigation results and the corrective actions taken to address the deviation.
2. Approve the deviation and corrective actions if the investigation is thorough, and the corrective actions are deemed sufficient to prevent recurrence (Annexure-5).
3. Ensure that the approval is documented, and all records are maintained in accordance with GMP guidelines.

5.6 Communication of Deviation Resolution

1. Once the process deviation has been resolved and the corrective actions approved, communicate the resolution to the Production Team and other relevant departments.
2. Update the affected batch records and process documentation to reflect the corrective actions taken.

5.7 Documentation and Record Keeping

1. 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.
2. 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

1. Process Deviation Log (Annexure-2)
2. Root Cause Investigation Report (Annexure-3)
3. Corrective Action Report (Annexure-4)
4. Process Deviation Approval Log (Annexure-5)
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