A Pest Control program needs to look at not only rodent control, but also flying and crawling insects. The program needs to be adequate to ensure that these contaminations are minimized to the lowest level possible.
Buildings used in the processing of a drug product are not maintained in a good state of repair.
The firm lacks an effective pest control plan, including controls for flying insects in the uncontrolled warehouse adjacent to the pharmacy area. The uncontrolled warehouse is used to
In the initial development of a plan with a licensed contractor, the chemicals and application process used need to be evaluated to ensure that they do not contaminate product for sale.
The control plan should contain a placement map of mechanical trap and spray pattern locations. Each mechanical trap should be located in a position that protects the trap from damage and loss and will be in a location of the pest activity that is being controlled. Traps should be designed for the environment they are placed in. Checks of each trap should be documented and the results recorded. Weather extremes are no excuse for the skipping of a routine check of an outdoor trap.
The process should be documented in an SOP to detail vendor, frequency and the actions to be taken for trap inspection results. All activities should be recorded in a log with a documentation of services provided and recording of any control findings by the vendor. Vendor provided documentation should be stored per corporate records retention policy. After receipt, these findings should be reviewed by facility management to acknowledge the issues and follow SOP actions for the findings.
Included in the binder should be the current state registered spray license of each person performing work for the vendor. Temporary replacements need to be documented to ensure that they are trained and familiar with the individual process.
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