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IPQ Monthly Update — August 2010

Now available, IPQ’s “Monthly Update -- August 2010” on key CMC/GMP developments in the US, Europe, and internationally. The IPQ family of publications has been expanded to include breaking stories “In the News” on our web site, “Weekly News Alerts” sent via e-mail, and the “Monthly Update.”...

IPQ Monthly Update — July 2010

The inaugural issue of IPQ’s “Monthly Update” on key CMC/GMP developments in the US, Europe, and internationally. The IPQ family of publications has been expanded this Spring to include breaking stories “In the News” on our web site, “Weekly News Alerts” sent via e-mail, and the “Monthly Update.” These now accompany our uniquely valuable in-depth “Special Reports” on emerging areas of concern drawing particular attention from industry and regulators....

IPQ Special Report — May 2010

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 […]

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.
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