pH, temperature, LOD, reaction time, and assay values. It includes initial detection, documentation, investigation, and resolution.

3. Responsibilities

• Production Chemist: Immediately report any deviation in IPC parameters, document initial observations, and stop further processing if required.
• QC Analyst: Verify parameter results and assist in evaluation of deviation cause.
• QA Officer: Log the deviation, initiate investigation, ensure impact assessment, and recommend CAPA if needed.

4. Accountability

The QA Head is accountable for ensuring deviation reporting, tracking, closure, and trend analysis. The Production Head is accountable for initiating immediate action in the event of any IPC deviation.

5. Procedure

5.1 Identification of IPC Deviations

1. During IPC checks, if any parameter is found outside the established acceptance criteria:
   • Immediately stop further processing of the affected batch stage.
   • Mark the equipment status as “ON HOLD.”
2. Document the deviation in the batch manufacturing record and notify QA and the production supervisor without delay.

5.2 Documentation and Notification

1. Record the following in the IPC Deviation Reporting Form (Annexure-1):
   • Batch No., Stage, Date & Time
   • Parameter and Observed Value
   • Expected Range
   • Instrument used and person reporting
2. QA shall assign a deviation number and initiate preliminary assessment.

5.3 Investigation and Evaluation

1. QA along with production and QC shall:
   • Conduct a root cause analysis (RCA)
   • Determine whether the deviation is minor, major, or critical
   • Evaluate the impact on product quality and other batches, if applicable
2. QA shall document findings in the deviation section of the IPC logbook and update the Deviation Register.

5.4 Corrective and Preventive Action (CAPA)

1. If required, CAPA shall be initiated to:
   • Correct the current issue (corrective action)
   • Prevent recurrence in future batches (preventive action)
2. QA shall track CAPA implementation and assess effectiveness.
3. All CAPAs shall be recorded in the CAPA Log and linked with the deviation report.

5.5 Deviation Closure

1. QA shall ensure that:
   • All investigations are complete
   • Impact assessment is documented
   • CAPAs are implemented and verified
2. Deviation shall be closed formally in the Deviation Register, signed by QA Head.

5.6 Trending and Review

1. QA shall conduct monthly/quarterly review of IPC deviations to:
   • Identify recurrence patterns
   • Assess system gaps or training needs
   • Improve processes accordingly
2. Deviations trending report shall be shared during management reviews.

6. Abbreviations

• IPC: In-Process Control
• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• RCA: Root Cause Analysis
• CAPA: Corrective and Preventive Action

7. Documents

1. IPC Deviation Reporting Form (Annexure-1)
2. Deviation Register
3. CAPA Log
4. BMR (Batch Manufacturing Record)

8. References

• ICH Q10 – Pharmaceutical Quality System
• 21 CFR Part 211 – cGMP for Finished Pharmaceuticals
• WHO TRS 986 – GMP Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: IPC Deviation Reporting Form

Date	Batch No.	Parameter	Observed Value	Expected Range	Stage	Reported By	Remarks
13/04/2025	API-20250413	pH	4.1	5.0–6.0	Post-Reaction	Ravi Kumar	Deviation Logged

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP Release	Compliance Requirement	QA Head
13/04/2025	2.0	Expanded CAPA and trending sections	Regulatory Audit Observation	QA Head