Standard Operating Procedure for Pest Control in Ointment Formulation

1) Purpose

The purpose of this SOP is to outline procedures for pest control in the ointment formulation area to prevent contamination and ensure a hygienic production environment.

2) Scope

This SOP applies to all areas where ointment formulation and packaging activities occur. It includes preventive measures, monitoring, and control procedures.

3) Responsibilities

– Facilities Management: Responsible for implementing and maintaining pest control measures.
– Quality Assurance (QA): Responsible for monitoring pest control activities and ensuring compliance with SOP.
– Production Staff: Responsible for reporting any pest sightings or issues to Facilities Management.

4) Procedure

1. Preventive Measures:
1.1 Facility Design:
1.1.1 Ensure all entry points are sealed to prevent pest ingress.
1.1.2 Install pest-proof screens on windows and vents.
1.2 Sanitation:
1.2.1 Maintain cleanliness in all production and storage areas.
1.2.2 Dispose of waste promptly and store it in pest-proof containers.

Monitoring:
2.1 Inspection:
2.1.1 Conduct regular inspections of the facility for signs of pests.
2.1.2 Use pest monitoring devices (e.g., traps, baits) to detect pest activity.

2.2 Documentation:
2.2.1 Document all inspection findings and pest control activities.
2.2.2 Maintain records of pest sightings and corrective actions taken.

Control Measures:
3.1 Chemical Control:
3.1.1 Use approved pesticides and pest control agents as per regulatory guidelines.
3.1.2 Apply pesticides safely and in designated areas to avoid contamination.

3.2 Non-Chemical Control:
3.2.1 Use physical barriers and traps to control pests.
3.2.2 Implement biological control methods where appropriate.

Response to Infestation:
4.1 Immediate Action:
4.1.1 Isolate affected areas to prevent the spread of pests.
4.1.2 Contact Facilities Management and QA immediately.

4.2 Remediation:
4.2.1 Clean and sanitize affected areas thoroughly.
4.2.2 Implement additional control measures to eliminate the infestation.

5) Abbreviations, if any

– QA: Quality Assurance
– SOP: Standard Operating Procedure

6) Documents, if any

– Pest Control Logs
– Inspection Records
– Pesticide Usage Records

7) Reference, if any

– FDA Current Good Manufacturing Practice (CGMP) Regulations
– WHO Guide to Good Manufacturing Practice (GMP) Requirements

8) SOP Version

Version 1.0