Client: Global Biopharmaceutical Manufacturer
Duration: 6 Months
Project Role: Project Leads - Two GMP Bridge Senior Consultants working under the direction of the Quality Director
Location: Several sites across the EU
Project Overview:
A global biopharmaceutical company specializing in biologics reached out to GMP Bridge to prepare for an upcoming GMP Inspection. With multiple manufacturing sites across different countries, the company faced the challenge of aligning its global operations with diverse regulatory requirements, particularly from the EU, FDA, and ANVISA.
GMP Bridge's Senior Partner led the project, applying a detailed approach to assess and remediate compliance gaps across sites to ensure inspection readiness.
Key Deliverables:
- Multi-Site GxP Audits: Conducted detailed GxP audits across the client’s international facilities, with a focus on contamination control, aseptic processing, and quality system management.
- Quality System Gap Analysis: Performed a comprehensive gap analysis of the client’s current quality systems, identifying deficiencies related to data integrity, equipment qualification, and personnel training.
- CAPA Development & Implementation: Collaborated with the client’s quality team to create and implement corrective and preventive action (CAPA) plans to address findings from the gap analysis.
- Training & Staff Development: Provided targeted training programs for staff, ensuring that everyone from the operators to the leadership team was aligned with updated processes and audit expectations.
- Mock Inspections: Led multiple mock audits and inspection simulations to prepare the client’s teams for real-world regulatory reviews, allowing them to practice and refine responses to potential auditor queries.
Results:
- Successful GMP HA Inspection: The client passed all regulatory inspections with zero major findings, ensuring continued production without delays or disruptions.
- Increased Staff Competency: The training provided empowered the client's staff to manage future audits with confidence and improved knowledge of GxP expectations.