SOP for Contamination Control

1) Purpose

To establish procedures for controlling contamination in pharmaceutical manufacturing processes to ensure product quality and regulatory compliance.

2) Scope

This SOP applies to all personnel involved in manufacturing, packaging, and testing of pharmaceutical products within the facility.

3) Responsibilities

Quality Assurance: Responsible for implementing and monitoring contamination control measures.
Manufacturing Personnel: Responsible for adhering to contamination control procedures during all manufacturing operations.
Facility Management: Responsible for maintaining clean and controlled environments.
Validation Team: Responsible for validating cleaning procedures and monitoring environmental conditions.

4) Procedure

1. Environmental Monitoring:
   1. Establish a monitoring program to assess cleanliness of critical areas and equipment.
   2. Monitor airborne particles, viable and non-viable particles, temperature, humidity, and differential pressure.
   3. Document monitoring results and take corrective actions as necessary.
2. Cleaning and Disinfection:
   1. Develop and validate cleaning procedures for equipment, surfaces, and facilities.
   2. Use appropriate disinfectants and cleaning agents approved for use in pharmaceutical manufacturing.
   3. Implement cleaning schedules and ensure compliance with frequency requirements.
3. Personnel Hygiene:
   1. Establish gowning procedures for personnel entering controlled areas.
   2. Provide training on proper gowning practices, hand hygiene, and behavior in cleanroom environments.
   3. Monitor and enforce hygiene practices to prevent contamination.
4. Raw Material and Packaging Material Control:
   1. Establish procedures for receipt, inspection, and storage of raw materials and packaging materials.
   2. Ensure materials are stored under appropriate conditions to prevent contamination.
   3. Implement controls to prevent mix-ups and cross-contamination.

5) Abbreviations, if any

SOP – Standard Operating Procedure

QA – Quality Assurance

6) Documents, if any

• Environmental Monitoring Reports
• Cleaning Validation Reports
• Training Records
• Gowning Procedures

7) Reference, if any

ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

8) SOP Version

Version 1.0