Production Facilities:
Clean Rooms: Controlled environments with regulated temperature, humidity, and particulate levels to prevent contamination.
Laminar Air Flow Hoods: Provide a sterile environment for aseptic processing.
Automated Systems: Minimize human intervention and reduce contamination risks.
Dedicated Equipment: Separate machinery for different stages to prevent cross-contamination.
Controls:
Environmental Monitoring: Regular testing for airborne particles, microbial contamination, and other environmental factors.
Personnel Hygiene: Strict protocols for gowning, handwashing, and behavior to maintain sterility.
Process Validation: Ensuring that manufacturing processes consistently produce products meeting quality standards.
Good Manufacturing Practices (GMP): Adhering to regulatory guidelines to ensure product quality and safety.
Documentation and Traceability: Comprehensive records of production batches, ingredients, and processes for accountability and regulatory compliance.