Manufacturing (production, packaging, storage and transportation) issues can impact patient safety. Therefore, there is an obligation to monitor and assess not only reported adverse events, but also the entirety of product complaints. Unfortunately, Product Complaints (PCs) and Adverse Events (AEs) are frequently analyzed by different groups in pharmaceutical companies. Effective monitoring and risk control require a coordinated approach to evaluate both AEs and PCs to ensure patient safety and optimal benefit /risk profile of products throughout the product lifecycle (ICH Q9, ICH Q10).
In addition to patient safety impact assessments [recalls, retrievals, mitigations, labeling changes],
the coordinated evaluation of AEs and PCs supports:
- Manufacturing quality processes
- Product specifications
- Safety focused feedback to research and development regarding product design and development
- Manufacturing change impact assessments
Members are needed for the GMP Links to Pharmacovigilance Interest Group, which will discuss these topics and will seek to help PDA members:
- Optimize benefit-risk calculus of the product and protect patients from avoidable risks due to manufacturing defects.
- Promote a positive feedback loop with R&D to ensure a product improvement.
- Develop clinically relevant product specifications
- Project Management
- Process Engineering
- Quality & Compliance
- Regulatory Affairs