Comprehensive GCP, GLP, and GMP Audits for Key Suppliers and CROs

Client: Clinical Stage Biotech Company
Duration: 6 Months
Project Role: Project Lead - GMP Bridge Senior Partner (GCP, GLP, GMP expert)

Location: USA & EU Audits performed

A U.S.-based biotech company with products in Phase I and Phase III of clinical research engaged GMP Bridge to conduct thorough audits of key suppliers and contract research organizations (CROs). The goal was to ensure compliance with Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP) standards. Two Senior Partners from GMP Bridge led the project, with one specializing in GCP and the other in GLP and GMP, ensuring a comprehensive evaluation of the suppliers and CROs involved in the clinical trials.

• GCP Audits: The GCP expert conducted focused audits of CROs responsible for clinical trial management, verifying adherence to GCP guidelines and ensuring the protection of trial participants' rights, safety, and well-being. Special attention was paid to data collection, documentation, and monitoring practices.
• GLP & GMP Audits: The GLP/GMP expert audited the key suppliers involved in the manufacturing and laboratory testing of investigational products. These audits covered both preclinical laboratory practices and manufacturing standards, assessing compliance with GLP and GMP regulations to ensure product quality and safety.
• Compliance Gap Identification: Across the GCP, GLP, and GMP audits, several compliance gaps were identified. The audits revealed issues with data integrity, documentation, and the control of laboratory and manufacturing processes. Each gap was analyzed, and recommendations were made to resolve non-compliance issues in a timely manner.
• Corrective Action Plans (CAPA): Tailored CAPA plans were developed for each supplier and CRO, addressing the specific non-compliance issues found during the audits. These plans included corrective actions to close compliance gaps and preventive actions to avoid future occurrences.
• Risk Mitigation Strategies: The Senior Partners worked closely with the client’s internal regulatory and quality teams to design risk mitigation strategies. This ensured that supplier and CRO processes aligned with both FDA and EMA regulations, protecting the client's Phase I and Phase III clinical programs from potential compliance risks.

• Improved Supplier & CRO Compliance: The audits led to improved compliance across all audited suppliers and CROs. CAPA plans were implemented successfully, addressing critical issues and reducing regulatory risk for the client’s clinical trials.
• Secured Clinical Trial Progression: The client’s Phase I and Phase III trials continued without disruption, as the audits and resulting corrective actions ensured that the suppliers and CROs met regulatory standards.
• Strengthened Regulatory Standing: By proactively addressing compliance gaps, the client strengthened its regulatory standing, positioning itself for successful interactions with both U.S. and international health authorities.