Context
A globally operating biopharmaceutical company acquired a production site utilizing more than 150 raw materials at various stages of vaccine production. The quality compliance team is looking for a partner to assess and remediate regulatory and quality compliance gaps.
Objectives
- Assess raw material data, identify compliance gaps and prioritize remediation actions according to risk severity.
- Develop and initiate a detailed remediation action plan in cooperation with local and global stakeholders.
Our Approach
Analyzing the current situation
- Interviewing raw material stakeholders (production units, quality control, supplier management, etc.).
- Assembling a master database list relevant internal raw material information and external requirements.
Assessing compliance gaps and associated risks
- Developing easy to use tools for a semi-automatic gap analysis followed by manual expert validation.
- Developing a data-based risk assessment protocol and applying it to cross-functional risk severity assessment workshops.
Planning remediation activities
- Prioritizing and clustering raw materials for remediation based on gap severity, risk and effort.
- Initiating and managing change control requests and coordinating remediation activities.
Results
- Raw material risk profile assessed for all active product lines.
- Client resources conserved through iterative pruning of the gap data set.
- The risk-based remediation action plan developed, aligned with global risk management strategy and initiated.
