SOP Guide for Pharma

API Manufacturing: SOP for Monitoring of Reaction Parameters – V 2.0

Auditor

API Manufacturing: SOP for Monitoring of Reaction Parameters – V 2.0

Standard Operating Procedure for Monitoring of Reaction Parameters in API Manufacturing

Department API Manufacturing
SOP No. SOP/API/022/2025
Supersedes SOP/API/022/2022
Page No. Page 1 of 11
Issue Date 13/04/2025
Effective Date 15/04/2025
Review Date 13/04/2026

1. Purpose

To establish a procedure for consistent and controlled monitoring of critical reaction parameters during API manufacturing to ensure process safety, quality, and reproducibility.

2. Scope

This SOP applies to all chemical reactions conducted in reactor systems within the API manufacturing facility, including pilot and production scale operations.

3. Responsibilities

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4. Accountability

The Production Manager and QA Manager are accountable for ensuring the defined process parameters are maintained, documented, and investigated in case of deviations.

5. Procedure

5.1 Pre-Reaction Verification

  1. Confirm calibration status of temperature sensors, pressure gauges, pH meters, and timers.
  2. Review the BMR for specified setpoints and permissible tolerance limits for:
    • Temperature
    • Reaction time
    • Pressure (if applicable)
    • Agitation speed
    • pH range (for aqueous/acid-base reactions)
  3. Ensure LOTO (Lockout Tagout) is not applied and reactor is safe to operate.

5.2 Parameter Monitoring During Reaction

  1. Temperature:
    • Monitor using digital display or DCS interface.
    • Record every 15 minutes during heating or cooling phase.
  2. Pressure (if applicable):
    • Check gauge pressure continuously in case of closed systems.
    • Log every 30 minutes during pressurized reactions.
  3. pH:
    • Use calibrated pH meter and sample every 30 minutes or as specified in BMR.
    • Record in the “Reaction Monitoring Log” (Annexure-1).
  4. Agitation:
    • Set RPM as per BMR and observe for uniform mixing.
    • Note any noise or unusual vibration and inform engineering immediately.
  5. Time:
    • Note reaction start and end time with operator initials.
    • Ensure minimum and maximum dwell times are followed.
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5.3 Handling Excursions

  1. If any parameter exceeds the acceptable range:
    • Pause the process if it poses safety risk.
    • Document the deviation in the “Reaction Deviation Form” (Annexure-2).
    • Inform the shift supervisor and QA immediately.
  2. Investigate root cause and implement corrective action before resuming process.

5.4 Documentation and Record-Keeping

  1. Record all observations in the BMR and “Reaction Monitoring Log.”
  2. Attach printed trends from automated systems (if available) for archival.
  3. Retain records as per documentation SOP and regulatory retention requirements.

6. Abbreviations

7. Documents

  1. Reaction Monitoring Log (Annexure-1)
  2. Reaction Deviation Form (Annexure-2)
  3. Calibration Certificates (Annexure-3)

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8. References

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Reaction Monitoring Log

Time Temp (°C) pH RPM Pressure (bar) Observed By
09:00 65.0 6.8 120 1.2

Annexure-2: Reaction Deviation Form

Date Batch No. Parameter Deviation Corrective Action Approved By
13/04/2025 API-202504 Temp Exceeded 70°C Reduced heating rate

Annexure-3: Calibration Certificates

Instrument ID Calibrated On Due Date Status
pH Meter PH-002 01/04/2025 01/10/2025 Calibrated

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2022 1.0 Initial Issue New SOP QA Head
13/04/2025 2.0 Added DCS and LOTO Requirements Process Enhancement QA Head
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