3. Responsibilities

• Warehouse/Production Staff: Identify and report signs of pest activity immediately to QA and EHS.
• Pest Control Contractor: Conduct preventive and corrective pest control as per schedule.
• QA Officer: Monitor records, trends, and audit pest control activities for GMP compliance.

4. Accountability

The EHS Manager is accountable for implementing and maintaining the pest control program, while the QA Manager ensures its compliance with GMP standards.

5. Procedure

5.1 Selection of Pest Control Service Provider

1. Only licensed, GMP-compliant pest control service providers shall be contracted.
2. Service provider shall submit:
   • Service contract
   • Material safety data sheets (MSDS) for chemicals used
   • Pest control layout plan

5.2 Pest Control Schedule

1. Activities include:
   • Rodent baiting – Monthly
   • Insecticidal spray – Fortnightly
   • Glue trap replacement – Weekly
   • Fogging (if required) – Quarterly or during infestation
2. Display the “Pest Control Calendar” at entrance of each zone (Annexure-1).

5.3 Monitoring Tools

1. Place pest control devices at:
   • Entry/Exit points
   • Raw material and finished goods storage areas
   • Utility and HVAC rooms
   • Drainage and wash areas
2. Assign device IDs as per location (e.g., RT01, GT05).
3. Maintain “Pest Control Monitoring Log” (Annexure-2) after each visit.

5.4 Record Review and Trending

1. QA to review the pest activity reports monthly for:
   • Pest type and location
   • Repetition of activity
   • Corrective action implemented
2. Initiate “Pest Incident Investigation Form” (Annexure-3) for repeated activity in same location.
3. Evaluate need for fogging or increased frequency based on trend.

5.5 Precautions During Pesticide Application

1. Ensure materials are covered or removed before pesticide application.
2. Do not spray in open production or sampling areas during operational hours.
3. Post signage during fogging or chemical application: “PESTICIDE IN USE – ENTRY RESTRICTED.”

6. Abbreviations

• SOP: Standard Operating Procedure
• MSDS: Material Safety Data Sheet
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• EHS: Environment, Health & Safety

7. Documents

1. Pest Control Calendar (Annexure-1)
2. Pest Control Monitoring Log (Annexure-2)
3. Pest Incident Investigation Form (Annexure-3)

8. References

• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• WHO TRS 961 – Annex 9: Good Storage and Distribution Practices
• 21 CFR Part 211.56 – Sanitation

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Pest Control Calendar

Month	Service Date	Service Type	Area Covered	Performed By
April 2025	05/04/2025	Rodent Baiting	Warehouse & Utility

Annexure-2: Pest Control Monitoring Log

Date	Device ID	Location	Pest Count	Corrective Action	Remarks
12/04/2025	RT03	Raw Material Bay	2	Glue Trap Replaced	Rodents observed

Annexure-3: Pest Incident Investigation Form

Date	Location	Type of Pest	Investigation Summary	Corrective Action	Verified By
10/04/2025	Sampling Room	Cockroach	Drain opening near entry point	Sealed drain, repeated fogging

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2022	1.0	Initial Release	GMP Requirement	QA Head
13/04/2025	2.0	Added Incident Investigation Annexure	Audit Observation	QA Head