Inside the global regulatory dialogue
| IPQ tracks the regulator/industry dialogue on evolving and harmonizing the regulation of pharmaceutical and biopharmaceutical quality and manufacturing.
Each issue provides an in-depth, cutting-edge report on a key focal point of concern – so readers understand the forces that are driving the dialogue and the emerging solutions that are being proposed. IPQ provides the insight needed to respond to these pivotal quality regulatory trends and developments. |
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Highlights of recent IPQ issues: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, and the control dots are being connected in new ways. Regulators will be expecting a more coherent and transparent approach to assuring process and product performance and managing the relevant knowledge. Joined with the principles in ICH Q8-10, the FDA guidance is challenging manufacturers to remodel their control strategies and come to grips with how much they know about their processes, how they know what they know, and how they can prove to regulators that they know it. Focal points of the industry/regulator dialogue on the impact of this new lifecycle validation paradigm include legacy products, risk assessment, knowledge management, deliverables, and compliance expectations. This issue's "Voices from the Dialogue" include:
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FDA warning letters and injunctions are frequently linking GMP problems with the manufacturing of products that do not have the required new drug approval or do not meet OTC monograph standards, as the agency's crackdown on the various types of unapproved drugs continues. In upgrading deviation investigation systems, regulators are looking for human factors analysis and a deeper understanding of the flaws in the quality system out of which the operator errors stem. FDA's foreign warning letters reveal the growing focus on supply chain control. For biologics, the challenges of vaccine production are getting increased inspection attention as this product segment expands. FDA is concerned that Biological Product Deviation Reports are not always getting submitted on time. This issue's "Voices from the Dialogue" include:
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 diversity of inspectors and regulatory agencies that manufacturers routinely face also is prompting them to clarify and refine their approach to managing inspections. The consensus from both sides of the Atlantic is that opening the communication channels is key to a positive inspection outcome and that putting up barriers to this interchange is counterproductive. The experts agree that the following are good inspection facilitators: •operator receptivity to dialogue •asking investigators to clarify requests and findings as needed •having records/applications available •being truthful •volunteering information that can help mitigate investigator concerns •understanding and addressing rather than arguing with concerns raised, and •supporting disagreements with data. Regulators want to see a sense of urgency from firms about their CAPA commitments in responding to inspection findings. This issue's "Voices from the Dialogue" include:
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. Coming to the fore is the tension between prescriptive guidance based on worst-case regulator experience and the advancement of a science and risk-based quality regulatory paradigm more adaptive to technology and harmonization. At issue in the discussions over the cleanroom classification/monitoring and vial capping provisions in the revised annex is how a manufacturer's valuable control resources can be most effectively deployed to analyze and address aseptic processing risks. The limitations of traditional microbial measurements versus the potential of science and engineering to find and eliminate contamination sources is among the big-picture concerns on the table. This issue's "Voices from the Dialogue" include:
Highlights of IPQ issues in 2008: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 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 arena…. 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…. 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…. 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…. |
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