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IPQ Inside the global regulatory dialogue


Welcome to International Pharmaceutical Quality (IPQ)

 

From breaking news to in-depth analysis, International Pharmaceutical Quality places its readers "Inside the Global Regulatory Dialogue"™ where the initiatives that will reshape the landscape are being defined

IPQ's incisive, cutting-edge analysis allows its readers to understand the forces that are driving the industry/regulator dialogue and the emerging solutions that are being proposed. IPQ provides the context and insight needed to respond to and impact these pivotal quality regulatory trends and developments and make informed decisions.

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The News in Depth

IPQ Monthly Update – August / September 2017 in Review

The three stories in this issue provide insights from industry and agency thought leaders on how the pharma imperatives of innovation, acceleration and regulatory harmonization are putting pressure on the existing regulatory processes and quality systems and what industry and agencies such as FDA are doing to try to evolve them.

November 13 2017 / Read More

FDA’s Office of Pharmaceutical Quality Advances Review/Inspection Integration

FDA has put in place an umbrella “Concept of Operations” (ConOps) intended to support the Office of Pharmaceutical Quality (OPQ) in its efforts to ensure consistency, efficiency, and transparency in facility evaluations, inspections, and regulatory decision-making for marketing applications and create a more cohesive review/inspection process.

October 23 2017 / Read More

Quality System Transformation Needed for Next-Gen Product Acceleration, Johnson & Johnson’s Sallans Tells ISPE/FDA/PQRI Conference

A transformation in quality systems is needed to liberate the power of information, digital, manufacturing and analytical technologies and accelerate the next generation of medical products reaching the patient, Johnson & Johnson Chief Quality Officer Francois Sallans affirmed in his keynote address at the opening of the ISPE/FDA/PQRI Quality Manufacturing Conference in June.

October 17 2017 / Read More

Updates in Brief

IPQ also provides "Updates in Brief" for its subscribers to alert them to breaking CMC/GMP developments.

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Subscription Benefits

Subscribe today and get 24/7 access to the IPQ family of publications:

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  • “In the News” — breaking stories on our website
  • “Weekly News Alert” — sent via email
  • “Monthly Update” — the key CMC and GMP developments in the US, Europe and internationally
  • “Special Reports” — in-depth analysis of specific, emerging issues of regulator/industry concern
  • Documents and Archives — Live links to all the documents referenced in our stories and full access to IPQ’s valuable archive library

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Front page Nov.Dec. 2015Click here for the November/December 2015 Monthly Update

 

IPQ’s Mission:

IPQ is dedicated to helping advance the dialogue on evolving and harmonizing the regulation of pharmaceutical and biologic quality and manufacturing.



IPQ takes its readers from:

  • ● the headlines to the forces driving them
  • ● regulations and policies to their underlying intent
  • ● the pieces of the puzzle to their interconnection
  • ● requirements to implementation pathways
  • ● random data to critical trends
  • ● the sidelines to helping shape the outcome
  • ● compliance problems to proactive quality tools
  • ● information to intelligence

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Subscribe today and get 24/7 access to the IPQ family of publications: In the News — breaking stories on our website; Weekly News Alert — sent via email; Monthly Update — the key CMC and GMP developments in the US, Europe and internationally; Special Reports — in-depth analysis of specific, emerging issues of regulator/industry concern; and Documents and Archives — live links to all the documents referenced in our stories and full access to IPQ’s valuable archive library.



Bill Paulson:
IPQ Editor-in-Chief

Before launching IPQ, Bill served for over two decades as the primary author of “The Gold Sheet.” During his career tracking the drug and biotech quality regulatory process, Bill's identification of key issues and problem areas and emerging solutions has been influential in the targeting of resources by industry and FDA and has impacted the dialogue on the shaping of new CMC and GMP policies. More about About Bill Paulson

 

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