http://www.pda.org/MainMenuCategory/Publications/IPQ.aspxInternational Pharmaceutical Quality and related IPQ publications will target the issues and challenges surrounding the international harmonization of pharmaceutical and biopharmaceutical regulation and help further the discussion about the regulatory approaches appropriate for advancing products and processes. Copyright 2008en-usFri, 30 Jul 2010 23:38:54 GMT1http://www.pda.org/MainMenuCategory/Publications/IPQ/JulyAugust-Issue.aspxTHE PROCESS VALIDATION PARADIGM IS CHANGING and the implications for the way manufacturers control their processes and regulators inspect them are being assessed.Thu, 24 Sep 2009 13:00:28 GMThttp://www.pda.org/MainMenuCategory/Publications/IPQ/MayJune-Issue--FREE.aspxN/ATue, 18 Aug 2009 13:27:03 GMThttp://www.pda.org/MainMenuCategory/Publications/IPQ/2009-May-June-IPQ.aspxANALYSIS 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.Mon, 20 Jul 2009 14:15:38 GMThttp://www.pda.org/MainMenuCategory/Publications/IPQ/MarchApril-2009.aspxDRUG 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. Fri, 15 May 2009 11:06:19 GMThttp://www.pda.org/MainMenuCategory/Publications/IPQ/January-February-2009.aspxTHE 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.Fri, 06 Mar 2009 09:13:18 GMThttp://www.pda.org/MainMenuCategory/Publications/IPQ/November-December-2008.aspxA 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.Fri, 09 Jan 2009 09:38:29 GMThttp://www.pda.org/MainMenuCategory/Publications/IPQ/September-October-2008.aspxTHE 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.Fri, 09 Jan 2009 09:53:30 GMThttp://www.pda.org/MainMenuCategory/Publications/IPQ/July-August-2008.aspxTHE 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.Mon, 27 Oct 2008 10:44:24 GMThttp://www.pda.org/MainMenuCategory/Publications/IPQ/May-June-2008.aspxEXPANDED 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.Mon, 27 Oct 2008 10:38:16 GMThttp://www.pda.org/MainMenuCategory/Publications/IPQ/March-April-2008.aspxTHE 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.Mon, 15 Sep 2008 20:47:31 GMThttp://www.pda.org/MainMenuCategory/Publications/IPQ/JanuaryFebruary.aspxTHE 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.Mon, 15 Sep 2008 20:49:51 GMThttp://www.pda.org/MainMenuCategory/Publications/IPQ/IPQ-Banner.aspxN/AFri, 09 Jan 2009 09:15:16 GMThttp://www.pda.org/MainMenuCategory/Publications/IPQ/NovemberDecember.aspxTHE EU IS ASSESSING ITS API QUALITY INITIATIVES to see how they are working in practice.Mon, 15 Sep 2008 20:52:04 GMThttp://www.pda.org/MainMenuCategory/Publications/IPQ/SeptemberOctober.aspxFirst Issue: APPLYING QUALITY BY DESIGN TO BIOPHARMACEUTICALS is testing the viability of the definitions that have been jelling in the small molecule context.Mon, 15 Sep 2008 20:52:54 GMT