US Pharmacopeia’s Convention 2005

At its 2005 Convention, USP passed 13 resolutions that will help define the organization’s path for the next five years and represent the interests of its diverse constituency.

Articles in this issue

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Analytical Methods Validation In-Process Control Methods for the Manufacture of Active Pharmaceutical Ingredients

April 2005

Management Controls for GMP Compliance

The Sector Chart: A New Engineering Graph for Pharmaceutical Processes

Validation of Alternative Microbiology Methods for Product Testing Quantitative and Qualitative Assays

PAT and Process Understanding: A Call to Arms

Cold Chain Concerns

Evolutions in Direct Compression

X-ray Microtomography of Solid Dosage Forms

Orient Express

Importance of Background Microbial Levels in the Manufacture and Testing of Sterile Products

Using Visible Residue Limits for Introducing New Compounds into a Pharmaceutical Research Facility

Comparative Evaluation of Three Active Air Samplers for the Monitoring of Airborne Microorganisms

Famine in Field Inspection

Establishing Target Fills for Semisolid and Liquid Dosage Forms

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July 30th 2025

FDA Shake-Up: Vinay Prasad Exits Amid Tumult in Biologics Oversight

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Prasad’s short FDA tenure brought stricter review standards for gene and COVID vaccines, sparking biotech concern and political backlash.

June 25th 2024

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

July 29th 2025

In-line UV Spectrometry Monitoring in Cleaning Validation

John Schallom Brian Bosso Paul Lopolito Katie Frey Amy Thanavaro

The authors performed interference and enhancement testing using a formulated alkaline and acid cleaner, as well as common biopharmaceutical process residues.

May 28th 2024

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Felicity Thomas

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

July 28th 2025

Boehringer Ingelheim, Re-Vana Therapeutics to Collaborate on Long-Acting Ophthalmic Therapies

Patrick Lavery

Re-Vana’s drug delivery technology is designed to release treatments over a 6- to 12-month period, with the goal of reducing frequency of injections for patients.

July 28th 2025

EMA Encourages Use of New Approach Methodologies to Reduce Animal Testing

Cheryl Barton

EMA is phasing out animal testing and is asking pharmaceutical companies to use new approach methodologies.

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July 30th 2025

FDA Shake-Up: Vinay Prasad Exits Amid Tumult in Biologics Oversight

Christopher Cole

Prasad’s short FDA tenure brought stricter review standards for gene and COVID vaccines, sparking biotech concern and political backlash.

June 25th 2024

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

July 29th 2025

In-line UV Spectrometry Monitoring in Cleaning Validation

John Schallom Brian Bosso Paul Lopolito Katie Frey Amy Thanavaro

The authors performed interference and enhancement testing using a formulated alkaline and acid cleaner, as well as common biopharmaceutical process residues.

May 28th 2024

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Felicity Thomas

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

July 28th 2025

Boehringer Ingelheim, Re-Vana Therapeutics to Collaborate on Long-Acting Ophthalmic Therapies

Patrick Lavery

Re-Vana’s drug delivery technology is designed to release treatments over a 6- to 12-month period, with the goal of reducing frequency of injections for patients.

July 28th 2025

EMA Encourages Use of New Approach Methodologies to Reduce Animal Testing

Cheryl Barton

EMA is phasing out animal testing and is asking pharmaceutical companies to use new approach methodologies.