THE CHALLENGES IN CONTROLLING EXTRACTABLES AND LEACHABLES are driving drug and biologic manufacturers and their vendors to explore new ways of comparing experience and sharing information. As product, process, packaging and delivery materials and systems evolve and their interactions grow more complex, industry is looking for pathways to make the E&L evaluation process more efficient and effective, and new collaborations are being formed that reach across the supply chain and the product lifecycle.
THE REACH OF QUALITY SYSTEMS INTO THE SUPPLY CHAIN is drawing FDA attention as it looks for industry support in assuring ingredient quality in a complex global marketplace. As the regulator/industry relationship evolves, the agency may need to follow the lead of other regulators and review the audit reports and management reviews done by pharmaceutical manufacturers to make sure that their quality systems have the necessary self-assessment and response capabilities.
THE EU IS ASSESSING ITS API QUALITY INITIATIVES to see how they are working in practice. An inspection survey of finished product manufacturers in the EU shows general compliance with the new expectations for supplier auditing and supply chain traceability. The European API industry, however, continues to lobby for more foreign inspection coverage to reflect the risks and level the GMP playing field. A new GMP database is part of an EMEA effort to strengthen compliance information sharing within and outside the EU.
APPLYING QUALITY BY DESIGN TO BIOPHARMACEUTICALS is testing the viability of the definitions that have been jelling in the small-molecule context. Establishing the linkage between quality attributes and clinical performance – a foundation block for the quality-by-design structure – is a particular challenge in the biotech arena, and pathways for tightening this linkage are being explored and discussed