Standard Operating Procedure for Pest Control in Creams Production Area
1) Purpose
The purpose of this SOP is to establish guidelines and procedures for pest control in creams production areas to prevent contamination and ensure a hygienic manufacturing environment.
2) Scope
This SOP applies to all areas involved in creams production, including manufacturing, filling, packaging, storage, and quality control areas.
3) Responsibilities
The Facilities and Maintenance department is responsible for implementing and maintaining pest control measures. The Quality Assurance (QA) department is responsible for monitoring the effectiveness of pest control activities and ensuring compliance with regulatory requirements.
4) Procedure
4.1 Pest Control Program
4.1.1 Develop a comprehensive pest control program that includes preventive measures, monitoring, and corrective actions.
4.1.2 Ensure the pest control program is approved by the Facilities, Maintenance, and QA departments.
4.2 Preventive Measures
4.2.1 Maintain cleanliness and sanitation in all areas to eliminate food and water sources for pests.
4.2.2 Seal all entry points, including doors, windows, and vents, to prevent pests from entering the production area.
4.2.3 Install pest-proof screens on windows and vents.
4.2.4 Store raw materials and finished products in pest-proof containers.
4.2.5 Regularly inspect and clean drains and waste disposal areas.
4.3 Monitoring
4.3.1 Set up monitoring devices, such as traps and bait stations, in strategic locations around the production area.
4.3.2 Regularly inspect and maintain monitoring devices to ensure their effectiveness.
4.3.3 Keep records of pest monitoring activities, including the location and number of pests detected.
4.4 Corrective Actions
4.4.1 If pests are detected, immediately implement corrective actions to eliminate the infestation.
4.4.2 Use only approved pest control chemicals and methods that are safe for use in a pharmaceutical manufacturing environment.
4.4.3 Document all pest control activities, including the type of pest, location, method of control, and outcome.
4.5 Training and Compliance
4.5.1 Provide training for personnel on pest control measures, including preventive actions and reporting procedures.
4.5.2 Conduct periodic refresher training and competency assessments for personnel involved in pest control activities.
4.5.3 Ensure compliance with all relevant regulatory requirements and industry standards for pest control in pharmaceutical production areas.
5) Abbreviations, if any
QA: Quality Assurance
6) Documents, if any
Pest Control Program
Pest Monitoring Records
Pest Control Activity Logs
Training Records
7) Reference, if any
US FDA CFR (Code of Federal Regulations) Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
WHO Technical Report Series, No. 961, 2011: Annex 9 – Guidelines on Packaging for Pharmaceutical Products
8) SOP Version
Version 1.0
