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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 – July/August 2018 in Review

The July/August issue begins with an exploration of how the ICH process has been evolving and the challenges and opportunities that are now presenting themselves. The second story then takes a deep dive into the intensive dialogue taking place on implementing ICH Q12 and its established conditions provisions, in particular. A series of three stories follows on the problems created by the different excipient regulatory frameworks and requirements around the world for both suppliers and users in their efforts to assure and improve the quality and availability of medicines.

October 1 2018 / Read More

Refined Training, Project Selection, and Membership Processes Strengthen ICH’s Global Harmonization Efforts

Refined processes for training, project selection and membership are strengthening ICH’s ability to realize in practice the global harmonization objectives of its guideline development efforts, ICH leaders are affirming.

September 6 2018 / Read More

IPEC Digesting Implications of China’s Ending of Separate Excipient Approval Process

The International Pharmaceutical Excipients Council (IPEC) is working with its members and China’s Center for Drug Evaluation [CDE] to digest and manage the implications of the decision in China to switch from a separate approval process for pharmaceutical excipients to submission and review of an excipient dossier together with a drug application.

August 31 2018 / 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

● “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/April 2018 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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