Subscribe
  
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.

Learn More Subscribe Now

The News in Depth

Role of Established Conditions Drawing Attention in Global Dialogue on ICH Q12’S Potential

The interpretation and application of the approaches for determining established conditions (ECs) provided in the Step 2 draft of ICH Q12 and how these interface with regulatory reporting expectations is drawing particular attention as industry explores the opportunities that the ICH Q12 concepts present in practice.

August 13 2018 / Read More

IPQ Monthly Update – May/June 2018 in Review

The issue includes in-depth stories on: ● the intensive dialogue going on now in the wake of the emergence of an ICH Q12 Step 2b draft for public comment ● the role EFPIA’s European Biopharma Enterprises (EBE) is playing in identifying and building consensus around the most pressing issues on the global regulatory agenda for biotech manufacturing and control, and ● the experience at a leading in vitro fertilization (IVF) clinic in figuring out the cause of dramatic periodic declines in the clinic’s normal best-in-class success rates and what needed to be done to prevent them, including the development of much more powerful air purification technology.

August 6 2018 / Read More

Experience with In Vitro Fertilization Clinics Raises Strong Warnings on Cell Culture/Processing Air Purification

Experience with in vitro fertilization (IVF) clinics is sending a strong signal that applying significantly heightened air purification standards and more advanced technology to meet them may be critical across all cell culture/processing operations.

July 16 2018 / Read More

Updates in Brief

IPQ also provides "Updates in Brief" for its subscribers to alert them to breaking CMC/GMP developments.

Subscriber Login



Subscription Benefits

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 – 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

.

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]

 

IPQ Sponsor Links

©2018 IPQ Publications