Subscribe
  
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.

Learn More Subscribe Now

The News in Depth

Wholesalers and 3PLs Continue to Advocate for DSCSA Goals of Strong and Uniform Licensing and Pedigree Requirements Nationwide

Wholesale distributors and third party logistics (3PLs) providers are continuing to affirm their desire to take on more stringent licensing and pedigree requirements in exchange for clarity and uniformity of the expectations across the U.S.

May 23 2016 / Read More

FDA/Industry Track and Trace Pilot Planning Sheds Further Light on Complex Web of DSCSA Implementation Challenges

The complexity of the web of issues that need to be worked through to arrive at a fully interoperable track and trace system in the U.S. for prescription pharmaceuticals by 2023 as mandated by the Drug Supply Chain Security Act (DSCSA) was in full display at an FDA pilot planning workshop in early April.

May 16 2016 / Read More

IPQ Monthly Update – February / March 2016 in Review

IPQ continues its in-depth exploration of the changes FDA is making to its quality regulatory structure, processes and expectations – their impact and global significance. Focal points include: ● a progress report on OPQ’s first year ● the manufacturing innovation taking place in the more nourishing regulatory environment ● other key issues on the current OPQ agenda ● CDER’s new risk-based API review process, and ● reviewer concerns with biotech product excipients. Also covered on the international front are EDQM’s efforts to drive API regulatory harmonization.

April 11 2016 / Read More

Updates in Brief

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

Subscriber Login



Subscription Benefits

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
  • Documents and Archives — Live links to all the documents referenced in our stories and full access to IPQ’s valuable archive library

.

 

 




 

 


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

.

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.



SIGN UP for your Free Weekly ‘IPQ Alerts’ Email

Get the latest news on pharmaceutical and biopharmaceutical quality regulation and manufacturing.

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

 

IPQ Sponsor Links

©2016 IPQ Publications