THE QUALITY REGULATORY INITIATIVES UNDERWAY AS THE NEW DECADE BEGINS show the strong imprint of ICH Q8-10 at both the agency and international levels. From CMC application review to GMP inspections, from development to post-market manufacturing, from the ingredient supply chain through product distribution, the quality-by-design, risk management and quality system principles built into the new ICH guidelines are being integrated into industry/regulator interactions and the guidance, policies and initiatives that define them.
THE PROCESS VALIDATION PARADIGM IS CHANGING and the implications for the way manufacturers control their process and regulators inspect them is being assessed. An FDA draft guideline has made clear that validation is a journey that extends across the process lifecycle from design to qualification to continued verification. Regulators will be expecting a more coherent and transparent approach to assuring process and product performance and managing the relevant knowledge.
ANALYSIS OF FDA AND EU GMP ENFORCEMENT ACTIVITY shows inadequate investigation of manufacturing and product nonconformances to be the most pressing concern on both sides of the Atlantic.
DRUG MANUFACTURERS ARE REASSESSING HOW THEY MANAGE REGULATORY INSPECTIONS as they shift focus onto the challenge of conveying the strength of their quality systems to find and address problems and risks.
THE REGULATORY STANDARDS FOR ASEPTIC PROCESSING ARE UNDER SCRUTINY as industry moves to interpret and implement the 2008 revisions to Annex 1 of the EU GMPs. At recent public forums, the dialogue on the implications of the Annex 1 revisions has brought to the surface deeper questions about the foundation on which aseptic processing standards have rested.
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.