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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

USP and IPEC-Europe Weigh in on GDPs for Excipients

USP and the European branch of the International Pharmaceutical Excipients Council (IPEC-Europe) have both released guidance for pharmaceutical companies on the evaluation and handling of excipient distribution....

January 19 2012 / Read More

IPQ’s Monthly Update for January is Now Available

Generic drug regulation has been very much in the IPQ spotlight recently on both the CMC review and GMP compliance fronts, with generic drug user fees nearing implementation, biosimilars on the horizon, and compliance problems surfacing at some of the big generics manufacturing operations....

January 18 2012 / Read More

FDA Generic Drugs Office Advances QbD, Review Processes and Quality Management System in Anticipation of User Fees

FDA’s Office of Generic Drugs (OGD) is making significant strides forward in its efforts to implement quality by design (QbD), refine its review processes and implement a quality management system, in anticipation of the resource underpinning that user fees will provide....

January 14 2012 / Read More

Consumer Complaints, FDA Inspection at Novartis Nebraska Plant Leads to Recalls and Temporary Manufacturing Shutdown

Consumer complaints of bottles containing mixed-up or damaged tablets and capsules and an extended FDA 483 focused on complaint handling at a Lincoln, Nebraska facility where they were made prompted Novartis to recall a handful of its over-the-counter (OTC) products and temporarily cease operations at the plant....

January 14 2012 / Read More

Key Pillars of a Quality Culture are Management Commitment, Sharing Inspection Results and Early QbD, Industry Execs Affirm

Key pillars for global pharmaceutical companies in building effective quality cultures within their organizations and extending them to their contract partners are commitment and communication by senior management, openly sharing inspection information across sites, and a quality-by-design approach beginning in early development, industry executives maintain....

January 12 2012 / Read More

View All News in Depth

Updates in Brief

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

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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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IPQ’s Mission

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

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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.



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Bill Paulson:
IPQ Editor-in-Chief

Bill Paulson: 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.

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