GMP Links to Pharmacovigilance

The GMP Links to Pharmacovigilance Interest Group will facilitate the incorporation of medical expertise and oversight in the form of a clinical assessment of the potential safety issues with product performance and Quality System elements.  Quality attributes of a product, including product specifications, are linked to patient experiences and add value to fundamental quality activities. 

The focused elements for this Interest Group are as follows:

• Risk control linked to medical patient risk
• To link Quality System elements to Pharmacovigilances and Approved Risk Evaluation and Mitigation Strategies (REMS)
• To address link recalls, complaints and adverse effects
• The establishment of and deviation from Critical Quality Attributes (CQAs) and the link to the Quality Target Product Profile (QTPP)
• The link to Regulatory filing issues (e.g., label claims).

The mission is achieved by:

• An improved understanding of the clinical (patient experiences) and GMP Quality Systems (product specifications)
• Discussing case studies of positive and negative experiences in this venue
• Contributing to global regulations and guidance as appropriate
• Sponsoring plenary sessions, break-out sessions, and possibly a conference to bring together experts in this field.