ISO 14644 Cleanroom Waste Management Audit Checklist

The checklist covers waste categorization and segregation procedures, containment methods, disposal protocols for different waste types, decontamination practices, waste transfer routes, personnel training on waste handling, documentation and record-keeping, and compliance with local and international waste disposal regulations.

Proper waste management prevents cross-contamination, reduces the risk of introducing contaminants into the cleanroom environment, and ensures that waste removal does not compromise the cleanliness levels required for pharmaceutical manufacturing.

The audit should involve cleanroom managers, environmental health and safety specialists, quality assurance personnel, waste management coordinators, and contamination control experts to ensure a comprehensive evaluation of all aspects of cleanroom waste management.

Comprehensive waste management audits should be conducted quarterly, with ongoing monitoring of waste handling practices. More frequent assessments may be necessary for high-risk waste streams or following changes in manufacturing processes that affect waste generation.

Identified deficiencies should trigger immediate corrective actions, such as revising waste handling procedures, retraining personnel, upgrading waste containment equipment, or reassessing waste disposal contracts. A follow-up audit should be scheduled to verify the effectiveness of these improvements.