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International Pharmaceutical Quality

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IPQ tracks the regulator/industry dialogue on evolving and harmonizing the regulation of pharmaceutical and biopharmaceutical quality and manufacturing. It is a free benefit for members of PDA and Partner Associations can receive half-price subscriptions. For more details contact paulson@ipqpubs.com. 

Editor Bill Paulson to Become International Pharmaceutical Quality (IPQ) Publisher
In mid-November, PDA is turning over the publishing responsibilities for IPQ to Bill Paulson, who will continue to provide IPQ to PDA members on a complimentary basis for an interim period while subscription, site licensing and sponsorship opportunities are being pursued.

PDA Members/Subscribers Only

  • Members OnlyJuly/August Issue
    THE PROCESS VALIDATION PARADIGM IS CHANGING and the implications for the way manufacturers control their processes and regulators inspect them are being assessed.

  • Members OnlyMay-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.

  • Members OnlyMarch–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.

  • Members OnlyJanuary – 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.

  • Members OnlyNovember-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.

  • Members OnlySeptember-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.

  • Members OnlyJuly-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.

  • Members OnlyMay-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.

  • Members OnlyMarch-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.

  • Members OnlyJanuary-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.

  • PDFNovember-December 2007
    THE EU IS ASSESSING ITS API QUALITY INITIATIVES to see how they are working in practice.

  • PDFSeptember-October 2007
    First Issue: APPLYING QUALITY BY DESIGN TO BIOPHARMACEUTICALS is testing the viability of the definitions that have been jelling in the small molecule context.

 
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