Pest Management Procedures in Vaginal Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to establish a comprehensive pest control program to prevent contamination and ensure a hygienic environment in the manufacturing of vaginal dosage forms.

2) Scope

This SOP applies to all areas within the pharmaceutical facility involved in the manufacturing, storage, and packaging of vaginal dosage forms.

3) Responsibilities

It is the responsibility of the Quality Assurance, Maintenance, and Production departments to implement and monitor pest control activities as outlined in this SOP.

4) Procedure

4.1 Pest Control Program Development

1. Develop a pest control program that includes routine inspections, preventive measures, and corrective actions.
2. Ensure the pest control program complies with regulatory requirements and industry standards.

4.2 Selection of Pest Control Service Provider

1. Select a qualified pest control service provider with experience in pharmaceutical facilities.
2. Verify that the service provider uses approved and safe pest control methods.

4.3 Pest Control Inspections

1. Conduct routine inspections of all facility areas, including storage and production zones, for signs of pest activity.
2. Document inspection findings and take immediate action to address any pest issues identified.

4.4 Preventive Measures

1. Implement preventive measures such as sealing entry points, maintaining cleanliness, and proper waste disposal.
2. Install and regularly inspect pest control devices such as traps and bait stations.

4.5 Corrective Actions

1. Develop and implement corrective action plans to eliminate pest infestations promptly.
2. Document all corrective actions taken, including the methods used and the results achieved.

4.6 Record Keeping

1. Maintain detailed records of pest control activities, including inspection reports, service provider logs, and corrective actions.
2. Ensure records are reviewed regularly and retained as per regulatory requirements.

4.7 Training

1. Provide training to personnel on pest control awareness, reporting procedures, and preventive measures.
2. Document training sessions and ensure all relevant staff are trained.

4.8 Monitoring and Review

1. Regularly monitor the effectiveness of the pest control program through audits and reviews.
2. Update the pest control program as needed based on review findings and regulatory changes.

5) Abbreviations, if any

N/A

6) Documents, if any

Pest control program documentation, inspection reports, corrective action logs, training records

7) Reference, if any

FDA Guidance for Industry: Pest Control in Pharmaceutical Manufacturing, WHO Guidelines on Pest Management, EU GMP Annex 1: Manufacture of Sterile Medicinal Products

8) SOP Version

Version 1.0