SOP Guide for Pharma

Elixir Department: SOP for Notification Protocol for IPC Failures – V 2.0

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Elixir Department: SOP for Notification Protocol for IPC Failures – V 2.0

Standard Operating Procedure for Notification Protocol for IPC Failures in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/209/2025
Supersedes SOP/ELX/209/2022
Page No. Page 1 of 8
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To define the procedure for immediate and structured notification in the event of In-Process Control (IPC) test failures during the manufacturing of elixirs. This ensures timely action, traceability, and regulatory compliance.

2. Scope

This SOP applies to all IPC failures observed during elixir manufacturing, including physical, chemical, and microbiological test results that fall outside predefined specifications or control limits.

3. Responsibilities

  • QC Analyst:
    • Identify, document, and immediately report IPC test failures to designated personnel.
  • Production Supervisor:
    • Halt the process upon notification and assist in sample re-testing and batch segregation.
  • QA Officer:
    • Initiate deviation report and conduct impact assessment on product quality.
See also  Elixir Department: SOP for Preservative Content Assay - V 2.0

4. Accountability

The QA Head is accountable for reviewing IPC failures and authorizing further action. The QC Head ensures appropriate documentation and investigation initiation.

5. Procedure

5.1

Identification of IPC Failure
  1. If a test result deviates from the defined specification in the Batch Manufacturing Record (BMR) or product standard:
    • Flag the result as IPC failure.
    • Repeat the test once using the same sample to confirm the observation.

5.2 Immediate Notification

  1. Notify the following personnel verbally and via email or documented log entry within 15 minutes:
    • Production Supervisor
    • QA Officer
    • QC Head
  2. Document the initial failure in the IPC Failure Notification Form (Annexure-1).

5.3 Action Upon Notification

  1. Production must:
    • Pause the batch process immediately.
    • Quarantine the batch and affected materials.
  2. QA must:
    • Review IPC results and start a preliminary investigation.
    • Decide on next steps: retesting, resampling, or deviation initiation.

5.4 Investigation and Documentation

  1. Complete a Deviation Form and assign a unique deviation number.
  2. Include:
    • Date and time of failure
    • Test parameter and method
    • Batch number and product details
    • Initial result and retest result
    • Impact assessment and immediate actions
  3. Attach this documentation to the BMR.

5.5 Resolution and Final Disposition

  1. Based on investigation outcome, QA decides:
    • Reprocessing
    • Rejection
    • Batch continuation (with justification)
  2. Communicate final disposition in writing to all stakeholders.

6. Abbreviations

  • IPC: In-Process Control
  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • QC: Quality Control
  • BMR: Batch Manufacturing Record

7. Documents

  1. IPC Failure Notification Form (Annexure-1)
  2. Deviation Report Form
  3. Batch Manufacturing Record (BMR)

8. References

  • 21 CFR Part 211.192 – Production Record Review
  • ICH Q10 – Pharmaceutical Quality System
  • 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 Failure Notification Form

Date & Time Batch No. Test Parameter Result Specification Notified To Initial Action
11/04/2025, 10:30 AM ELX-0425-027 pH 8.2 6.5 – 7.5 Sunita Reddy (QA) Process Paused

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Release New SOP QA Head
11/04/2025 2.0 Included mandatory response timelines and escalation list Regulatory Alignment QA Head
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