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IPQ Special Report — July/August 2009

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.

IPQ Special Report — May/June 2009

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. 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 […]

IPQ Special Report — March/April 2009

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. […]

IPQ Special Report — January/February 2009

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 […]

IPQ Special Report — November/December 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 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.

IPQ Special Report — September/October 2008

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.

IPQ Special Report — July/August 2008

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.

IPQ Special Report — May/June 2008

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.

IPQ Special Report — March/April 2008

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.

IPQ Special Report — January/February 2008

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.
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