Inside the global regulatory dialogue

July/August issue now available

IPQ and related publications will track the regulator/ industry dialogue on evolving and harmonizing the regulation of pharmaceutical and biopharmaceutical quality and manufacturing.

First two issues available for free download.

About the July/August issue

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. Reflecting 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. As the management focus grows, the role of the qualified person and the quality unit is being reevaluated to make sure that the regulatory expectations are viable and reflect the actual decision-making power. Industry and regulators are wrestling also with how best to apply the new paradigm concepts in the API and excipient context so that requirements are clear, harmonized, fair and enforceable. Third-party certification is gaining traction as a way of providing support in excipient control. Industry/regulator trust-building is seen as key to realizing the quality system’s potential.
Bill Paulson, Editor-in-Chief