thoroughly investigated, documented, and resolved. QA ensures that corrective and preventive actions (CAPA) are implemented and that the final resolution complies with regulatory requirements.

Management Team: Responsible for ensuring that proper resources are available to address deviations and that corrective actions are effectively implemented.

4. Accountability

The Production Manager is accountable for identifying and reporting deviations during production. The QC Manager is responsible for investigating the deviations and ensuring that any required testing or analysis is completed. The QA Manager is responsible for ensuring compliance with this SOP and for approving corrective actions.

5. Procedure

5.1 Identifying and Reporting Deviations

1. During the production process, if any deviation from the approved procedures, specifications, or standards occurs, the production team must immediately report it to the QC and QA teams.
2. Deviations can include, but are not limited to, incorrect raw materials, improper processing parameters (e.g., temperature, pH, mixing time), equipment malfunction, or out-of-specification test results.
3. Document the deviation in the Deviation Report (Annexure-1), including the nature of the deviation, the affected batch, time of occurrence, and any immediate corrective actions taken by the production team.

5.2 Documenting Deviations

1. The Deviation Report (Annexure-1) must include the following details:
   • Batch number
   • Deviation description
   • Date and time of occurrence
   • Initial corrective actions taken
   • Potential impact on product quality
   • Investigating team (QC/QA)
2. The completed Deviation Report must be submitted to the QA team for further investigation and approval.

5.3 Investigating Deviations

1. The QA team is responsible for conducting a thorough investigation into the deviation. The investigation should address the following:
   • Root cause analysis to identify why the deviation occurred (e.g., human error, equipment failure, raw material issue).
   • Assessment of the impact of the deviation on product quality, safety, and compliance.
   • Evaluation of the risk to other batches or future production runs.
2. The QC team will support the investigation by conducting any required testing or analysis to assess the quality of the affected batch, such as retesting raw materials or rechecking product specifications.
3. If the cause of the deviation cannot be immediately identified, a more detailed investigation may be required, including the review of historical data, equipment maintenance logs, and personnel training records.

5.4 Implementing Corrective Actions

1. Based on the findings of the investigation, the QA team will determine the appropriate corrective actions to prevent recurrence of the deviation. These actions may include, but are not limited to:
   • Adjusting production procedures or equipment settings
   • Replacing or recalibrating faulty equipment
   • Re-training production staff on the correct procedures
   • Changing raw material suppliers if the deviation is related to material quality
2. Corrective actions should be implemented immediately and must be documented in the Deviation Report.
3. The QA team must ensure that all corrective actions are verified for effectiveness and that the batch is re-evaluated to confirm that the deviation has been resolved.

5.5 Preventive Actions

1. After addressing the immediate deviation, the QA team will evaluate whether preventive actions are required to reduce the likelihood of similar deviations occurring in the future.
2. Preventive actions can include process changes, equipment upgrades, or enhanced quality control checks. These actions should be documented in the Corrective and Preventive Action (CAPA) log (Annexure-2).
3. Once preventive actions are implemented, they must be monitored to ensure their effectiveness and be periodically reviewed during internal audits or management reviews.

5.6 Closing the Deviation Report

1. Once corrective and preventive actions have been implemented, and the batch is verified to be in compliance, the deviation report can be closed.
2. The final report, including investigation findings, corrective actions, preventive actions, and any other relevant information, must be reviewed and approved by the QA Manager.
3. The completed Deviation Report and associated documentation must be filed and stored in accordance with GMP guidelines for future reference and audit purposes.

5.7 Documentation and Record-Keeping

1. Ensure that all deviation-related documentation, including the Deviation Report, CAPA log, investigation reports, and corrective action records, are stored for a minimum of two years or as required by regulatory guidelines.
2. All deviation records should be easily accessible for internal audits, external inspections, and regulatory reviews.
3. Ensure that all records are signed and dated by the responsible parties to maintain accountability and traceability.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QC: Quality Control
• QA: Quality Assurance
• PPE: Personal Protective Equipment
• CAPA: Corrective and Preventive Action

7. Documents

1. Annexure-1: Deviation Report
2. Annexure-2: CAPA Log

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• FDA Guidance for Industry: Deviations Handling in Pharmaceutical Manufacturing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Deviation Report

Batch Number	Deviation Description	Corrective Action Taken	Resolved By	Resolution Date
12345	Deviation in pH during mixing	Adjusted mixing process, re-tested pH	QA Head	22/01/2026

Annexure-2: CAPA Log

Corrective Action Description	Preventive Action Description	Implementation Date	Responsible Person
Recalibrated mixing equipment	Scheduled regular equipment calibration	23/01/2026	Maintenance Supervisor

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/03/2024	1.0	Initial Version	New SOP Creation	QA Head
01/03/2025	2.0	Format Revision and Updates	Standardization of Document	QA Head