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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

MHRA Inspectors are Advocating Data Mapping as a Key First Step on the Data Integrity Pilgrimage

Data process mapping is being strongly encouraged by inspectors from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as a first step in planning, establishing, and maintaining the controls necessary to secure data integrity.

June 13 2019 / Read More

IPQ Monthly Update – March/April 2019 in Review

The March/April 2019 issue provides the first two in a series of four IPQ stories on the current developments and industry/regulator interactions around data integrity. Explored are: ● the revisions that FDA and PIC/S have made to their DI guidances as part of a deepening pool of resources that industry now has available to support its data governance efforts, and ● how the role of quality culture is getting more attention as the regulator and industry DI guidances evolve.

June 7 2019 / Read More

Data Integrity Compliance Experts Are Urging Industry to Apply Regulator Perspective and Learnings in Refining Data Systems and Auditing

Data integrity (DI) regulatory compliance experts are observing that industry in-house and third-party auditors are often not detecting failures because they are not viewing the systems and processes in the same manner as agency inspectors.

May 29 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

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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 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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