Standard Operating Procedure for Rodent and Pest Control in pharmaceutical facility
1. Purpose
To provide a standard operating procedure for Rodent and Pest Control in pharmaceutical facility.
2. Scope
The scope of this SOP is applicable Rodent and Pest Control in pharmaceutical facility at [company name].
3. Responsibility
Licensed Rodent and Pest Control agency:
● To perform pest control activity.
● To procure and bring required chemicals and tools for rodent and pest control activity
● To maintain antidotes with chemicals and pesticides.
● To impart training to the personnel who does rodent and pest control in the facility with authorized and certified trainers.
● To consult and suggest Company Authority regarding any excursion in Rodent and Pest.
● To consult and suggest Company Authority revision with respect to required revision in the SOP depending on need and trend.
● To maintain Material Safety Data Sheet (MSDS) at site.
HR and Administration department:
● To monitor and supervise the operations.
● To ensure compliance of the SOP.
● To trend the rodent and pest control data and analyze it for excursions.
● To review day to day data for adequacy and routine operation and review records.
● HR technician to carryout support day to day activity of verification and data recording.
● To audit pest control agency and periodic basis along with Quality Assurance department.
4. Definitions
Rodent: Rodents are small mammals which have sharp front teeth that include rats, mice, squirrels, hamsters, porcupines, and their relatives.
Pest: Pest is a destructive insect or other animal that attacks crops, food, livestock, etc.
5. Procedure
5.1 Pest Control
● Pest control in the pharmaceutical manufacturing facility shall be done using the following three-layered approach.
● Pest control outside the factory building and surrounding the building shall be done every week. The Pest control of surroundings is essential to control the pest in the periphery of the facility.
● Second layer of pest control is done using physical control, sanitization, and fly killing. Physical control is done using an air curtain at entry points, tightly closed doors, and airlock facility. [Air curtain and airlocks also play an important role in contamination control].
● Sanitization of door entry points, platforms (for e.g. receiving and dispatch bay), airlock, and inside the facility play a vital role in controlling pest intrusion. Maintaining cleanliness at the entry point reduces attraction and the possibility of instruction inside the facility. In addition, locating UV light-based fly killers at both sides of the doors (outer side of the manufacturing, warehouse) will attract flies towards fly killers and prevent its intrusion.
● Third layer of protection is sanitization of the inside facility, fly killer (inside airlocks and inside warehouse door (both sides of door)), and to some extent, glue trap will further help to reduce the pest intrusion inside the manufacturing, warehouse and other areas if it enters by crossing first and second layer of protection.
● Fly killers and glue traps shall be monitored on a daily basis for the number of flies killed by counting them in the tray and stuck on a glue trap.
● For the pest control in the periphery of the plant, pest control agency personnel shall visit the factory premises as per frequency of pest control defined in the SOP.
● Pest control activity shall be done outside the building and in cafeteria.
● Before doing pest control in the cafeteria, all the eatables, drinkables and utensils should be removed and after pest control, eatable, drinkables and utensils should be taken back after resting period suggested by the pest control agency.
● Personnel Protective Equipment and clothing process must have to adhere by involved personnel in the activity.
● The person from the pest control agency shall prepare required solution as per concentration defined in the respective format.
● The pest control agency personnel shall spray the solution as per listed area in the SOP.
● Record for solution preparation and pest control activity shall be maintained.
● HR personnel shall review the activity done as intended and shall do the signature in the record after review.
| Months | Malathion 50% EC w/w | Cypermethrin 10% EC w/w | Chlorpyriphos 20% EC | Pine oil | Bromadiolone | Glue pad |
| Use | General Arthropoda | To control broad-spectrum insects | Termite control | Mosquito Control | Rodenticide | To control rodent |
| Frequency | Fortnightly | Fortnightly | Fortnightly | Fortnightly | Daily | Daily |
| January | X | — | X | X | X | X |
| February | — | X | — | X | X | X |
| March | X | — | X | X | X | X |
| April | X | X | — | X | X | X |
| May | X | X | X | X | X | X |
| June | — | X | — | X | X | X |
| July | X | — | X | X | X | X |
| August | X | X | — | X | X | X |
| September | X | X | X | X | X | X |
| October | — | X | — | X | X | X |
| November | X | X | — | X | X | X |
| December | X | X | X | X | X | X |
● Fly killers and glue traps shall be monitored on a daily basis for the number of flies killed by counting them in the tray and stuck on a glue trap.
● The record of the above observation shall be maintained and shall be trended. The record of fly killers and glue traps record is an indicator of seasonal variation and effectiveness of pest control measures.
● Once the seasonal trend is available, action and alert limit can be defined and monitored on daily basis to track if any spike observed during routine monitoring.
● Depending on the seasonal and overall trend, the frequency of pest control treatment can be re-defined.
● Fly killer UV lights shall be replaced every six-monthly (or recommended by UV light manufacturer).
5.2 Rodent Control
● Roda Box, Rodent Bait Station or Glue Pads are used for rodent control in the factory premises.
● Roda Box, Rodent Bait Station or Glue Pads are placed as per location chart and location map.
● Observation with respect to rodent shall be recorded on daily basis.
● The record shall consist of details such as availability of poison cake (yes/ no) and any rodent identified or not.
● In case, rodent is observed, it shall be collected into polybag shall be handed over to pest control agency to dispose it.
● The fresh Glue pad shall be placed at the designated location if rodent found trap on it and record the observation in respective logbook.
5.3 above procedure shall control rodents such rat, mice, lizard, and pest and Insects such as spider, flies, mosquito, cockroach etc.
5.4 Record of all the activities shall be maintained in respective log books.
5.5 General antidotes shall be maintained at site as recommended by pest control agency and factory medical officer.
5.6 In case of any accidental exposure of pest control chemical, person shall be taken to the nearest hospital. Antidotes shall be carried to the hospital along with patient and handed over to the doctor. Based on the doctor’s diagnosis, it may be helpful to the patient.
5.7 List of available antidotes and its validity shall be maintained at site.
6. Frequency
Pest Control – Fortnightly
Monitoring of Rodent – Daily
Monitoring of Glue Trap – Daily
Monitoring of insectocutor – Daily
Trending of data:
Rodent data trending: Yearly
Glue trap data trending: Yearly
Insectocutor data trending: Yearly
7. Formats
Format for Pest Control Solution Preparation
Format for Pest Control
Format for verification of Rodent Bait Station
Format for verification of Glue trap
Format for Rodent Bait Station and Glue trap location chart
Format for trending of rodent, insect and flies
Format for list of antidotes