— including dispensing, mixing, deaeration, filling, and in-process checks — where deviations from predefined specifications may occur.

3. Responsibilities

• Production Personnel: Identify and report deviations promptly.
• Production Chemist: Initiate immediate containment actions and notify QA.
• Quality Assurance (QA): Investigate, evaluate, and document deviations and corrective actions.

4. Accountability

The Head – Manufacturing is accountable for ensuring timely identification, escalation, and resolution of deviations within the Gel Manufacturing Department.

5. Procedure

5.1 Identification of Deviations

1. Monitor for any anomaly or non-conformance in process parameters, environmental controls, equipment functioning, material attributes, or documentation.
2. Examples include: incorrect pH value, over/underweight filling, air entrapment, unexpected color change, equipment malfunction, etc.
3. Immediately record the deviation in the Deviation Log (Annexure-1).

5.2 Initial Containment Actions

1. Halt the process and isolate affected material or batch if critical deviation is observed.
2. Label the material/batch as “Under Investigation.”
3. Retain evidence or samples for QA evaluation.

5.3 Communication Protocol

1. Inform the Production Chemist and QA Officer immediately upon detecting a deviation.
2. QA shall log the deviation and classify it as minor or major.
3. QA will determine whether immediate process resumption is permissible or if full investigation is needed.

5.4 Immediate Corrective Actions

• Adjust machine settings (e.g., fill volume, mixing speed, temperature) within approved ranges.
• Replace or recalibrate faulty instruments if required.
• Reprocess only after QA approval and batch impact assessment.
• Restart operation only after QA line clearance is obtained.

5.5 Documentation and Follow-up

1. Record all corrective actions in the Corrective Action Record (Annexure-2).
2. QA to determine if CAPA (Corrective and Preventive Action) is required.
3. Update Batch Manufacturing Record (BMR) with deviation summary and actions taken.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• BMR: Batch Manufacturing Record
• CAPA: Corrective and Preventive Action

7. Documents

1. Deviation Log – Annexure-1
2. Corrective Action Record – Annexure-2

8. References

• ICH Q10 – Pharmaceutical Quality System
• WHO TRS 986 Annex 2 – GMP Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Deviation Log

Date	Time	Batch No.	Description of Deviation	Reported By	Initial Action	QA Remarks

Annexure-2: Corrective Action Record

Batch No.
Deviation ID
Corrective Action Taken
Person Responsible
Date of Action
QA Approval

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
01/06/2022	1.0	Initial release	New SOP	QA Head
02/06/2025	2.0	Expanded procedure and updated annexures	Process Improvement	QA Head