| Title: Pest Control | |||||
| Guidance Number: 075 | |||||
| Prepared by: | Date: | Supersedes: | |||
| Checked by: | Date: | Date Issued: | |||
| Approved by: | Date: | Review Date: | |||
Pest Control
Introduction
This document provides guidance in the implementation and maintenance of pest control program for buildings and facilities at a GMP Site and Logistics Centers that are used for production, testing, or storage of the following:
- Raw Materials,
- Starting Materials,
- In-Process Materials,
- Intermediates,
- Active Pharmaceutical Ingredients (API),
- Drug Products,
- Over-The-Counter (OTC) Products,
- Cosmetic products,
- Biologics, or
- Medical Devices.
1. Each Site Pest Control Program should be supervised by a qualified Site Pest Control Coordinator who should ensure that the program is coordinated among departments, the Site Quality Team and any contracted pest control service employees allowed on Site.
2. Chemical Application should be restricted to areas not used for production, testing, and/or storage of items listed above without prior written approval of the Site Quality Team.
3. Contractor Employees Applying Pesticides should be accompanied by a Site employee escort when pesticides are applied in areas of potential product exposure or in production areas.
4. All Pest Control Treatments and Inspections should be recorded and the records maintained in a manner approved by the Site Pest Control Coordinator. Records should display the location, date, and time of treatment or inspection, the chemicals applied, traps and equipment inspected, the name of the individual making the application or inspection, and, when an escort is required, the name of the Site employee who served as escort.
5. The Frequency of Inspection of Rodent Traps Inside Buildings used for production, testing, and/or storage of items listed above and rodent traps used outside such buildings should not exceed one month.
6. The Frequency of Inspection, Emptying and Cleaning of Bug Lights should not exceed one month. Inspection frequencies should be increased whenever conditions, such as seasonal increases in insect population, warrant it. Bug light bulbs should be changed annually and positioned to avoid attracting outdoor insects toward the building.
7. Where Installed, Air Curtains should be tested for proper performance upon installation. Periodically, at least monthly, air curtains should be inspected to confirm they are operating properly. One example of verifying proper operation is the paper test (open the door, stand outside, toss paper and it should come back to you).
8. Material Safety Data Sheets for each pest control chemical used should be maintained and available at the Site for reference.
9. Periodic Inspections should be conducted at least annually by qualified pest control experts to determine the effectiveness of pest control practices and integrity of buildings at each Site.
10. Pest Control Contractor Agreements should require:
- Written evidence of the qualifications of the contractor firm and each contractor employee;
- Schedules of treatments, inspections, and other services;
- Commitment to provide samples of pest control chemicals used at the Site, when requested for analytical testing; and
- Commitment to provide written procedures for approval by the Site Quality Team that describe the operating and reporting practices to be followed by contractor employees, including those for spill cleanup and other emergencies.
11. Building Openings should be screened and doorframes, window frames, and openings for utility services sealed to prevent the ingress of insects or other pests. Air handler intakes and exhausts should be designed to prevent entry of insects.
12. Steel Panel Buildings should be sealed at the footings, and all other seams inspected and sealed as necessary to minimize the vulnerability of typical steel panel construction to the entry of wall climbing insects and other pests.
13.
13. Direct-Access Exterior Doors should be prohibited from production areas where APIs, drug products, or medical devices may be exposed, or designated for emergency use only.
14. A No-Vegetation Buffer Zone should be provided at the exterior perimeter of every building used for production, testing, and/or storage of items listed above.
15. Inspection and Maintenance Frequency should be increased when specific practices or events occur that contribute to potential pest invasion. Such specific practices include, and are not limited to:
- Food service within a production building where food waste may attract pests;
- Warehouses which open to the outdoors allowing entry of pests;
- Rain creating breeding conditions for pests;
- The presence of nearby construction which can create migrations of rodents and insects; and
- Heat-shrink operations conducted after dark that can attract insects.