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IPQ Inside the global regulatory dialogue


Welcome to International Pharmaceutical Quality (IPQ)

 

INTERNATIONAL PHARMACEUTICAL QUALITY provides in-depth coverage of emerging drug, biologic and combination product CMC and GMP issues and developments, with a mission of helping advance and harmonize the quality regulatory process globally. Headquartered in Washington, IPQ is read by regulatory agencies and organizations, suppliers, consultants, law firms, and universities around the world.

IPQ tracks the industry/regulator dialogue at key international forums along with the developments, initiatives, regulations, guidances and standards in the quality regulatory arena to create a uniquely valuable resource for the intelligence gathering, knowledge management, and external communication needs of the pharmaceutical community.

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The News in Depth

COVID-19 Vaccine Urgency Throws Spotlight on Next-Gen Sequencing for Virus Control

The urgency of delivering a vaccine for COVID-19 in previously unattainable timeframes and volumes is throwing the spotlight on the expanded role next-generation sequencing (NGS) needs to play to avoid the time delays and other limitations of in vivo/animal testing.

PART II: Sanofi Pasteur and Ghent University Experience with NGS [CLICK HERE]

PART III: A Decade of Regulator/Industry Collaboration on NGS [CLICK HERE]

PART IV: Stakeholder Engagement Begins on ICH Q5A Revision [CLICK HERE]

PART V: Effort to Reduce Animal Testing for Vaccines Includes Global Health Fund Support for NGS
[CLICK HERE]


May 31 2020 / Read More

NIIMBL Progress Includes Partnership with Biophorum on Buffer Mixing and Global Health Fund with Gates Foundation

The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is partnering with the industry consortium BioPhorum to develop a more streamlined, cost-effective, and resource-conserving way of addressing the buffers used in biopharmaceutical manufacturing.

May 15 2020 / Read More

IPQ Monthly Update – March 2020 in Review

The first story in the March Monthly Update explores recent FDA global field inspection and enforcement operations. In focus are: ● the impact of the pandemic ● the field office’s API and drug product inventory and enforcement tools ● recent warning letter and import alert data and trends, and ● progress on the goals of reducing the timelines for inspection classification/notification and warning letter issuance. The following story provides insights from FDA’s drug compliance management on the recent global developments and trends of significance across the API, OTC, sterile product, compounding, and supply chain arenas.

April 23 2020 / Read More
 

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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

● “News Alerts” — sent via email

● “Monthly Updates” — 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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CLICK HERE  for the IPQ Monthly Update – March 2020 in Review


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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IPQ Editor-in-Chief

Paulson_picBefore launching IPQ in 2007, Bill Paulson served for over two decades as the primary author of “The Gold Sheet." During his career, Bill’s reporting and analysis has supported the global regulatory dialogue on advancing and harmonizing CMC and GMP processes for drugs and biologics to keep pace with the evolving technology.

 

Email: [email protected]

 

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