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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 – August 2021 in Review

The feature story in this issue centers on the challenges and developments around raw material control for biological products. A main focus is the discussion that took place at a USP workshop on the raw material issues held in April 2021. The story’s three parts delve into: ● FDA views on where the regulatory concerns and expectations lie across the review and inspection continuum ● how the challenges expand in handling raw materials in the CGT context, and ● where biomanufacturers are in using and controlling polysorbates, in particular.

September 19 2021 / Read More

Biomanufacturer Raw Material Control on Regulatory Front Burner as Analytical Power and Formulation Challenges Intensify

A more powerful analytical toolbox is allowing industry and regulators to better understand how biotech product manufacturers can improve the control strategies for the raw materials they are using. However, there are still significant knowledge and control gaps, and experts from industry, regulatory agencies, and pharmacopeias are actively sharing insights on how best to fill them.


Part I: Biotech Regulator Vantage Point on Raw Material Control


Part II: The Added Challenges of Materials Management for CGTs


Part III: Biomanufacturer Use and Control of Polysorbates

September 10 2021 / Read More

IPQ Monthly Update – July 2021 in Review

The feature story in this issue explores the dialogue regulators and industry are having on the key CMC issues that are presenting themselves in the development and review of peptides and oligonucleotides and the approaches and expectations for addressing them. A central focus is the discussion that took place at the USP 2021 peptides/oligonucleotides workshop. The story’s four parts explore: ● recent CMC/regulatory challenges of oligonucleotide drugs ● comparability challenges in crossing over to generics, including insights from recent FDA research ● comparing peptide and oligonucleotide CMC issues, and ● starting material specifications for oligonucleotides.

August 23 2021 / Read More
 

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

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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 – July 2021 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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IPQ Editor-in-Chief

Paulson_picBefore launching IPQ in 2007, Bill Paulson 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: p[email protected]

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