GMP Repackaging Audit Services

​Ensure your pharmaceutical repackaging operations meet GMP requirements, regulatory expectations, and industry best practices with our specialist GMP repackaging audit services. We provide independent, risk-based audits designed to assess compliance, product integrity, traceability, and quality system effectiveness within pharmaceutical repackaging and secondary packaging operations.

​

Our audits help pharmaceutical manufacturers, repackaging facilities, distributors, and contract service providers identify compliance gaps, reduce operational risk, and maintain inspection readiness for regulatory authorities and client audits.

​

Our GMP Repackaging Audit Services Include:

​

• Repackaging facility GMP audits

• Secondary packaging process assessments

• Line clearance and segregation reviews

• Label control and reconciliation audits

• Batch documentation and GDP compliance reviews

• Packaging material management assessments

• Supplier and contract repackager qualification audits

• Warehouse and storage condition evaluations

• Data integrity and documentation assessments

• Deviation, CAPA, and change control reviews

• Pre-regulatory inspection readiness audits

• Risk-based GAP analysis against GMP requirements

​

Areas We Assess:

​

• Repackaging and relabelling operations

• Packaging line controls and reconciliation processes

• Product traceability and batch segregation

• Environmental and contamination control measures

• Personnel GMP training and practices

• Packaging documentation and record accuracy

• Equipment qualification and maintenance

• Storage, handling, and distribution controls

• Quality Assurance oversight and release procedures

• Compliance with EU GMP, MHRA, FDA, and PIC/S expectations

​

​

Supporting Compliance and Product Integrity:

​

Repackaging activities require robust controls to maintain product quality, patient safety, and regulatory compliance. Our audits provide a comprehensive assessment of your repackaging operations, helping strengthen quality systems, improve process controls, and support ongoing inspection readiness.