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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

IPQ Monthly Update – September/October 2019 in Review

The issue begins with an exploration of how USP is evolving its standard setting approach for the new generation of biologic products and processes, and follows with a complementary review of the challenges in raw material and excipient use in biologics, in particular. The next two stories focus on the regulator and industry learnings, respectively, in gaining experience with the unique considerations that cell and gene therapies present in facility and operation management.

November 13 2019 / Read More

Industry Experience with Autologous Cell Therapies Underscores Need for Upfront Planning on Integrating Facility Design, Operations, and Supply Lines

Industry experience with autologous cell therapies is matching up with that of regulators in underscoring the importance of comprehensive integrated planning – encompassing internal operations and facility design as well as the complexities of the supply chain – to be able to meet future capacity needs.

November 8 2019 / Read More

The Processing and Formulation Complexities of Therapeutic Biologics Compel Heightened Focus on Excipient Needs

The processing and formulation complexities of the new generation of therapeutic biologics are compelling industry and regulators to take a hard look at the risks and requirements of the raw materials and excipients involved.

November 5 2019 / Read More
 

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● “In the News” — breaking stories on our website

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● “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 – September/October 2019 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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Bill Paulson:
IPQ Editor-in-Chief

Paulson_picBefore launching IPQ in 2007, Bill 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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