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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.