Chinese CRO/CMO Quality Evaluation

Chinese CROs are comprised of multinational- and Chinese-operated CROs. While all CROs in China offer significant discounts in pricing relative to CROs in the US or EU, there are capabilities and /or quality limitations that need to be considered. Pharma-GPS has screened several of the top tier Chinese CROs and, on behalf of US clients, led targeted audits of Chinese CROs/CMOs involved in preclinical and clinical studies to evaluate capabilities and quality systems.

Quality Systems Auditing

Our multilingual auditors are fluent in English, Mandarin, and Cantonese, and have significant pharmaceutical/biotechnology development and manufacturing industry experience, with expertise in GLP, GMP, and GCP compliance.

Audit Process

The process typically involves a 2-3 day high-level audit.  We review: training records; sample traceability/audit trail; instrument calibration, maintenance, documentation of activities; written SOPs; IT systems, data collection procedures; software/computer system validation; electronic records; document storage and archival procedures; IRB/IEC policies, procedures, documentation; animal rooms, laboratory sample handling and storage; and systems to protect the client's intellectual property.  Quality of the animal sourcing/supply chain and expertise in veterinary pathology is also assessed.

Report and Remediation Plan

Our reporting process includes an executive summary produced within 2 weeks of the on-site inspection, and a final report within 3 weeks of the inspection.  The report will include a complete summary of the audit, including detailed findings, grading of the importance of the findings, and suggested corrective actions as part of a remediation plan.

Training

Our staff is available to customize training programs for Chinese CROs/CMOs for the purpose of achieving compliance for GLP/GMP/GCP.