SOP Guide for Pharma

Creams: SOP for Handling Emergencies in Machine Operations – V 2.0

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Creams: SOP for Handling Emergencies in Machine Operations – V 2.0

Standard Operating Procedure for Handling Emergencies in Machine Operations

Department Creams
SOP No. SOP/CRM/120/2025
Supersedes SOP/CRM/120/2022
Page No. Page 1 of 5
Issue Date 21/01/2026
Effective Date 26/01/2026
Review Date 21/01/2027

1. Purpose

The purpose of this SOP is to establish a procedure for effectively handling emergencies during machine operations in the cream manufacturing process. It aims to ensure the safety of personnel and equipment, minimize product loss, and maintain a quick and efficient response to emergency situations.

2. Scope

This SOP applies to all machine operations within the cream manufacturing process, including mixers, homogenizers, filling machines, and other equipment used in the production process. It covers procedures for identifying, responding to, and managing emergencies such as machine malfunctions, power failures, leaks, and spills.

3. Responsibilities

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4. Accountability

The Production Supervisor is accountable for ensuring that emergency response procedures are followed. The Maintenance Supervisor is responsible for resolving the technical aspects of machine malfunctions, and the Safety Officer is responsible for ensuring the safety of personnel during emergency situations.

5. Procedure

5.1 Identifying Emergency Situations

  1. Monitor machine operations continuously during production to detect signs of malfunctions or irregularities.
  2. Emergency situations may include, but are not limited to:
    • Machine failure (e.g., motor breakdown, blade malfunction)
    • Power failure
    • Leaks or spills of cream or other ingredients
    • Overheating or fire hazards
    • Electrical malfunctions
  3. If an emergency is identified, immediately stop the machine to prevent further damage or safety risks.

5.2 Immediate Actions

  1. Press the emergency stop button to halt machine operations immediately.
  2. Disconnect the power supply if the issue involves electrical malfunction or fire hazard.
  3. If there is a risk of fire or explosion, activate the fire suppression system and evacuate personnel if necessary.
  4. For leaks or spills, contain the material to prevent contamination and minimize product loss. Use absorbent materials or designated spill kits for containment.
  5. Alert the Maintenance Team, Safety Officer, and Production Supervisor about the emergency situation and provide details of the issue.

5.3 Diagnostic and Corrective Actions

  1. The Maintenance Team should assess the situation to identify the root cause of the problem, such as mechanical failure, electrical issue, or equipment malfunction.
  2. If the issue can be resolved immediately, the Maintenance Team should perform repairs or adjustments to restore the machine to working condition. This includes replacing faulty components, resetting controls, or recalibrating equipment.
  3. If the equipment cannot be repaired quickly, take the machine out of service and replace it with backup equipment, if available, to minimize production downtime.
  4. Ensure that all repairs are documented in the Equipment Maintenance Log (Annexure-1), including the cause of the emergency, corrective actions taken, and any parts replaced.
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5.4 Post-Emergency Procedures

  1. After resolving the emergency, perform a complete inspection of the equipment to ensure it is safe to resume operations.
  2. Verify that the equipment is functioning properly, and all necessary parameters (e.g., speed, temperature, pressure) are within acceptable ranges before restarting the machine.
  3. Ensure that the production environment is secure and that there are no lingering hazards (e.g., spills, leaks) that could pose a risk to personnel or product quality.
  4. If necessary, conduct a trial run to verify that the equipment is operating at optimal performance levels.
  5. Once the machine is operational, resume production and document the emergency response in the Incident Report Log (Annexure-2).

5.5 Documentation and Record-Keeping

  1. Record the emergency situation, immediate actions, corrective actions, and any deviations from standard procedures in the Incident Report Log (Annexure-2).
  2. Document any maintenance or repairs performed in the Equipment Maintenance Log (Annexure-1) and ensure that these records are reviewed by the Quality Control team for compliance with GMP standards.
  3. Ensure that all records are retained for a minimum of two years or as per regulatory requirements.
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6. Abbreviations

7. Documents

  1. Annexure-1: Equipment Maintenance Log
  2. Annexure-2: Incident Report Log

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: Equipment Maintenance Log

Equipment ID Maintenance Date Maintenance Activity Operator Comments
HM-001 21/01/2026 Replaced faulty motor John Doe Machine running smoothly post-repair

Annexure-2: Incident Report Log

Incident Date Batch Number Incident Description Corrective Actions Operator
21/01/2026 12345 Power failure during mixing Rebooted system, adjusted mixing settings Jane Smith

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/03/2024 1.0 Initial Version New SOP Creation QA Head
01/03/2025 2.0 Format Revision and Updates Standardization of Document QA Head
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