Pharmaceutical Continuous Manufacturing Process Audit Checklist

Continuous manufacturing process audits should be conducted at least bi-annually, with more frequent assessments during initial implementation or after significant process changes. Additionally, ongoing monitoring and periodic reviews of critical process parameters should be performed regularly.

This checklist covers process analytical technology (PAT) implementation, real-time release testing strategies, material traceability and flow control, process control and automation systems, continuous process verification, data integrity in continuous operations, and regulatory compliance specific to continuous manufacturing.

These audits are typically conducted by a multidisciplinary team including process engineers, quality assurance specialists, PAT experts, and regulatory affairs professionals with expertise in continuous manufacturing technologies and regulations.

The checklist ensures that the continuous manufacturing process meets regulatory expectations, including FDA and EMA guidelines on continuous manufacturing, which is crucial for regulatory acceptance and compliance in this innovative manufacturing approach.

If significant deviations are identified, actions should include immediate assessment of impact on product quality, investigation of root causes, adjustment of process parameters or control strategies, potential re-validation of affected process steps, and thorough documentation of all findings and corrective actions. In severe cases, consideration of reverting to batch processing may be necessary while issues are resolved.