Standard Operating Procedure for Contamination Control

1) Purpose

This SOP outlines the procedures for controlling contamination risks in pharmaceutical manufacturing processes to ensure product quality and compliance with regulatory standards.

2) Scope

This SOP applies to all areas and processes within the pharmaceutical manufacturing facility where contamination control measures are critical.

3) Responsibilities

All personnel involved in pharmaceutical manufacturing are responsible for implementing contamination control measures outlined in this SOP. Quality Assurance (QA) ensures compliance with this SOP and regulatory requirements.

4) Procedure

4.1 Risk Assessment

1. Conduct risk assessments to identify potential sources of contamination in manufacturing processes.
2. Classify contamination risks based on severity and likelihood of occurrence.

4.2 Facility Design and Maintenance

1. Design manufacturing facilities with considerations for contamination control, including segregation of clean and dirty areas, HVAC system design, and material flow.
2. Maintain facilities and equipment according to validated cleaning and maintenance schedules.

4.3 Personnel Hygiene

1. Enforce strict personnel hygiene practices, including gowning, hand hygiene, and exclusion of ill employees from production areas.
2. Provide regular training on hygiene practices and behavior expectations within controlled environments.

4.4 Raw Material and Component Control

1. Implement controls for incoming raw materials and components to prevent contamination before entry into manufacturing processes.
2. Verify the cleanliness and integrity of raw materials through testing and supplier qualification.

4.5 Equipment Cleaning and Sterilization

1. Clean and sterilize manufacturing equipment according to validated procedures before and after use.
2. Verify equipment cleanliness through visual inspection and testing where applicable.

4.6 Environmental Monitoring

1. Monitor environmental conditions such as air quality, surface cleanliness, and particulate levels in critical manufacturing areas.
2. Use validated methods and instruments for environmental monitoring, and respond promptly to any deviations.

4.7 Incident Management

1. Document and investigate contamination incidents to determine root causes and implement corrective actions.
2. Communicate findings and corrective actions to relevant personnel and departments.

4.8 Documentation and Record Keeping

1. Maintain comprehensive records of contamination control activities, including risk assessments, cleaning logs, environmental monitoring results, and incident reports.
2. Review and update contamination control procedures and records regularly based on continuous improvement and regulatory requirements.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance
HVAC: Heating, Ventilation, and Air Conditioning

6) Documents, if any

Contamination Control Plan, Risk Assessment Reports, Cleaning and Maintenance Schedules, Incident Investigation Reports

7) Reference, if any

Regulatory guidelines such as EU GMP Annex 1 Manufacture of Sterile Medicinal Products, FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice

8) SOP Version

Version 1.0