A GLOBALLY COORDINATED RESPONSE TO THE DRUG SUPPLY CHAIN PROBLEMS is being called for, as the realization takes hold among the various stakeholders that the only effective and affordable option is a unified effort. The call for collaborative action to better assure pharmaceutical ingredient quality and supply chain integrity has been forcefully sounded at recent regulator/ industry conferences, and momentum for an international consortium is rapidly building.
THE IMPACT OF QUALITY BY DESIGN ON BIOTECH REGULATION is growing. An FDA biotech QbD pilot and industry mock initiatives are getting underway that will build on the experience gained in the small molecule area. In the biotech context, the focus is shifting to the API and the challenges of defining critical quality attributes and design space for these complex molecules and processes.
THE IMPACT OF QUALITY SYSTEM PRINCIPLES ON INSPECTION PRACTICE IS EXPANDING in depth and breadth as EU and U.S. regulators seek to evolve their GMP guidance and compliance programs in line with the new ICH Q8-10 paradigm. Reflcting Q10’s focus on the responsibilities of company management, inspectors will assess the level of management’s engagement with the quality system as a barometer of the system’s potential effectiveness.
EXPANDED FDA RESOURCES AND ENFORCEMENT TOOLS ARE NEEDED to allow the agency to handle the challenges of overseeing a global marketplace, FDA and its stakeholders are telling a newly receptive U.S. Congress. In the wake of a series of serious health threats from quality breakdowns in the global supply chain, including deaths from adulterated heparin, Congress has been holding hearings to assess the implications and is developing legislation to help FDA catch up with its health protection mandates and complete its transition into an international regulatory authority.
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