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 – February 2019 in Review

The February 2019 issue provides an in-depth review of: ● FDA’s increased focus on water systems as microbial contamination problems, particularly with B. cepacia, continue to surface around the world in non-sterile as well as sterile products and drive changes to the US and European pharmacopeias, and ● the role of the U.S. National Institute of Standards (NIST), in collaboration with a host of stakeholders, in creating a more robust standards infrastructure to support the complex development, manufacturing, and control challenges presented by rapidly evolving biotech products and processes.

April 9 2019 / Read More

Cell and Gene Therapy Initiatives Prominent on Biomanufacturing Agenda of U.S. National Institute of Standards and Technology

The growing need for standards in the rapidly evolving world of biopharmaceuticals and cell and gene therapies (CGTs) is giving rise to an expanding array of collaborative initiatives, products, and processes, many of which are flowing through the U.S. National Institute of Standards and Technology (NIST).

March 27 2019 / Read More

FDA’s Focus Has Sharpened on Water Systems in the Wake of Nonsterile Product Microbial Contamination

FDA has been sharpening its focus on water systems during inspections of nonsterile liquid products as microbial contamination problems of significance in these products continue to surface.

March 11 2019 / Read More

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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

● “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




CLICK HERE for the IPQ Monthly Update – January 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


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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