SOP for Preventing Cross-Contamination in Production

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

Date	Area	Activity Performed	Operator Initials	QA Approval
DD/MM/YYYY	Production Area	Cleaning/Inspection/Material Transfer	Operator Name	QA Name