Standard Operating Procedure for Preventing Cross-Contamination in Production
1) Purpose
This SOP outlines the procedures for preventing cross-contamination in GMP-regulated production areas, ensuring product safety and compliance with GMP standards.
2) Scope
This SOP applies to all personnel working in production areas at [Company Name].
3) Responsibilities
- Operators: Follow protocols to prevent cross-contamination during production activities.
- Supervisors: Monitor compliance with cross-contamination prevention measures.
- Quality Assurance (QA): Regularly review production areas to ensure adherence to cross-contamination prevention measures.
4) Procedure
4.1 Segregation of Production Areas
4.1.1 Dedicated Production Zones
- Maintain dedicated areas for the production of different products or dosage forms. Ensure that production lines are physically separated to avoid cross-contamination.
- Label all production areas clearly, indicating the product being manufactured.
4.1.2 Airflow and Ventilation
- Ensure that the HVAC system is properly maintained and that airflow is directed from clean areas to less clean areas to prevent airborne contamination. Use HEPA filters where necessary.
- Document any changes in airflow patterns and report deviations in the environmental control log.
4.2 Personnel Hygiene and Gowning
4.2.1 Gowning Procedures
- All personnel must wear the appropriate protective garments, including gloves, hairnets, and shoe covers,
when entering production areas. Change garments between shifts and before entering areas where different products are being manufactured.
Gowning areas must be equipped with clean garments, and personnel must follow SOP for gowning to prevent contamination.
4.2.2 Hand Hygiene
- All personnel must wash hands thoroughly with soap and water and use hand sanitizers before entering production areas. Perform hand hygiene before and after handling materials.
4.3 Equipment Cleaning and Maintenance
4.3.1 Cleaning Between Batches
- Clean all production equipment thoroughly between product batches to prevent contamination. Follow cleaning procedures outlined in the cleaning SOP and document all cleaning activities in the cleaning log.
- Conduct visual inspections of equipment after cleaning to ensure that no residues remain. Report any deviations to the supervisor.
4.3.2 Maintenance of Equipment
- Perform routine maintenance of all production equipment as per the maintenance schedule. Document maintenance activities in the equipment maintenance log.
- Ensure that any damaged equipment is repaired or replaced immediately to prevent contamination risks.
4.4 Material Handling
4.4.1 Segregation of Materials
- Segregate raw materials, intermediates, and finished products to prevent cross-contamination. Store materials in clearly labeled containers and ensure that storage areas are segregated by product type.
- Maintain separate storage areas for hazardous materials, active ingredients, and excipients.
4.4.2 Material Transfer
- Follow approved transfer protocols when moving materials between different production areas. Use dedicated equipment for specific materials, and document all material transfers in the batch manufacturing record (BMR).
4.5 Post-Operation Activities
4.5.1 Documentation
- Record all activities related to cross-contamination prevention, including cleaning, maintenance, and material handling, in the appropriate logs (e.g., cleaning log, maintenance log).
- Submit all documentation to QA for review and approval before starting a new batch.
5) Abbreviations, if any
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
- HEPA: High-Efficiency Particulate Air
6) Documents, if any
- Cleaning Log
- Maintenance Log
- Environmental Control Log
7) References, if any
- Internal SOP for cleaning and maintenance
8) SOP Version
Version 1.0
Annexure
1. Cross-Contamination Prevention Log Template
| Date | Area | Activity Performed | Operator Initials | QA Approval | |
|---|---|---|---|---|---|
| DD/MM/YYYY | Production Area | Cleaning/Inspection/Material Transfer | Operator Name | QA Name | |