SOP-PCM-045.01.
Standard Operating Procedure (SOP)
for
Pest Control & Monitoring
SOP-PCM-045.01.1
YIXING JIANGSHIAN BIO-TECH CO. LTD.
Address: Xudu Village, Zhoutie Town, Yixing City, Jiangsu Province
Tel: +86-510-87571899; +86-510-87579012
Email:
[email protected] SOP-PCM-045.01.1
1. Purpose
To establish a comprehensive system for the prevention, control, and monitoring of pests
within the pharmaceutical manufacturing plant, ensuring product quality, safety, and
compliance with regulatory requirements.
2. Scope
This SOP applies to all areas within the pharmaceutical plant, including production,
warehousing, laboratories, offices, and surrounding outdoor areas.
3. Responsibilities
Pest Control Contractor: Responsible for implementing pest control measures,
maintaining records, and providing training to plant personnel.
Production/Warehouse Personnel: Responsible for reporting any signs of pest
activity (e.g., sightings, droppings, damage).
Quality Control/Assurance Department: Responsible for reviewing pest control
records and ensuring compliance with this SOP.
4. Procedures
4.1. Pest Control Program
Selection of Pest Control Contractor:
o Select a reputable and licensed pest control contractor with experience in
pharmaceutical environments.
o Ensure the contractor uses Integrated Pest Management (IPM) principles,
which emphasize prevention and minimize the use of pesticides.
Pest Control Treatment:
o The pest control contractor shall conduct regular inspections and treatments as
per a predetermined schedule.
o Treatment methods may include:
Physical Control: Trapping, exclusion (e.g., sealing entry points),
sanitation.
Chemical Control: Use of approved pesticides in accordance with
label instructions and safety guidelines.
Pest Control Records:
o The pest control contractor shall maintain detailed records of all pest control
activities, including:
Date of service
Areas treated
Pesticides used (including name, concentration, and quantity)
Observations (e.g., pest sightings, droppings)
Corrective actions taken
YIXING JIANGSHIAN BIO-TECH CO. LTD.
Address: Xudu Village, Zhoutie Town, Yixing City, Jiangsu Province
Tel: +86-510-87571899; +86-510-87579012
Email:
[email protected] SOP-PCM-045.01.1
4.2. Monitoring and Inspections
Routine Inspections:
o Plant personnel shall conduct daily visual inspections of designated areas for
signs of pest activity.
o Focus on areas with potential pest harborages (e.g., corners, cracks, crevices).
Pest Control Contractor Inspections:
o The pest control contractor shall conduct regular inspections to assess pest
activity and adjust treatment plans as needed.
Monitoring Devices:
o Utilize monitoring devices such as glue traps, bait stations, and insect light
traps to detect and monitor pest activity.
4.3. Good Housekeeping Practices
Maintain a clean and sanitary environment throughout the plant.
Promptly address any spills or leaks.
Store food and other attractants properly.
Keep outdoor areas free of debris and vegetation that can harbor pests.
4.4. Training
Provide training to all plant personnel on:
o Good housekeeping practices
o Recognition of pest signs
o Reporting procedures
o Safety procedures related to pest control
5. Records
Maintain accurate and complete records of all pest control activities, including:
o Pest control service reports
o Inspection reports
o Monitoring data
o Training records
Store all records in a secure and easily accessible location.
6. Deviations and Corrective Actions
Investigate any unexpected pest activity or deviations from the established
procedures.
Implement corrective and preventive actions to prevent recurrence.
7. Review
Review the pest control program periodically to ensure its effectiveness.
Update the SOP as needed to reflect changes in pest activity, regulatory requirements,
or best practices.
YIXING JIANGSHIAN BIO-TECH CO. LTD.
Address: Xudu Village, Zhoutie Town, Yixing City, Jiangsu Province
Tel: +86-510-87571899; +86-510-87579012
Email:
[email protected] SOP-PCM-045.01.1
YIXING JIANGSHIAN BIO-TECH CO. LTD.
Address: Xudu Village, Zhoutie Town, Yixing City, Jiangsu Province
Tel: +86-510-87571899; +86-510-87579012
Email:
[email protected]