requiring investigation and corrective action.

3. Responsibilities

• Production Operator: Immediately report any IPC result outside specification or expected range.
• QC Analyst: Verify the result, initiate rechecking if justified, and inform QA for deviation handling.
• QA Officer: Lead the investigation, determine root cause, and initiate CAPA as needed.

4. Accountability

The Production Head and QC Head are accountable for accurate reporting and timely investigation of IPC outliers. QA Head is responsible for closure of investigation and ensuring regulatory compliance.

5. Procedure

5.1 Identification of Outlier Results

1. Any IPC result deviating from the target or defined specification limit must be flagged immediately.
2. Examples include unexpected pH, LOD, yield, color, assay, or TLC/HPLC profiles.
3. Use predefined limits from MFR or IPC test methods for comparison.

5.2 Initial Assessment

1. Production and QC jointly assess potential assignable causes:
   • Instrument error
   • Sampling error
   • Calculation mistake
   • Human error
2. If assignable cause is identified and justifiable, recheck may be allowed with QA approval.

5.3 Repeat Testing Criteria

1. Repeat analysis must be justified and documented in IPC Outlier Investigation Form (Annexure-1).
2. Only two re-tests permitted; original result must not be discarded or replaced without investigation closure.
3. If retest confirms the outlier, initiate deviation and stop further processing if needed.

5.4 Investigation and Documentation

1. QA initiates formal investigation using deviation or non-conformance form.
2. Include details such as:
   • Batch No., IPC test performed, date/time
   • Initial and retest results
   • Possible causes, corrective action, preventive action (CAPA)
3. Root cause analysis may involve tools like 5-Why or Fishbone diagram.

5.5 Disposition and Closure

1. QA Head reviews investigation report and decides on batch status: Reprocess, reject, or proceed.
2. Final decision and justification to be recorded in the batch record.
3. Investigation should be closed within 10 working days.

6. Abbreviations

• IPC: In-Process Control
• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• OOT: Out of Trend
• OOS: Out of Specification
• CAPA: Corrective and Preventive Action

7. Documents

1. IPC Outlier Investigation Form (Annexure-1)
2. Batch Manufacturing Record
3. CAPA Register / Logbook

8. References

• ICH Q7 – GMP for APIs
• ICH Q10 – Pharmaceutical Quality System
• 21 CFR Part 211 – US FDA GMP

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 Outlier Investigation Form

Date	Batch No.	Test Performed	Observed Result	Limit	Re-Test Results	Root Cause	CAPA	Status
13/04/2025	API-20250413	pH	2.1	3.0–5.0	2.1, 2.2	Incorrect neutralization	Training & SOP update	Closed

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP Release	Regulatory Compliance	QA Head
13/04/2025	2.0	Defined retesting limits and deviation timelines	Audit Improvement	QA Head