Quality Systems

J. Mark Wiggins is owner and compendial consultant with Global Pharmacopoeia Solutions LLC.

Joseph A. Albanese, director of Analytical Strategy and Compliance at Janssen Research and Development, LLC

Articles

Processes, people, and tools are needed to comply with the pharmacopoeia and approved drug product registrations.

Pharmacopoeia Compliance:  A Practical Guide

The Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) has issued its final opinion on measures for companies to take that will limit the presence of nitrosamines in human medicines.

EMA Issues Final Opinion on Nitrosamines

EMA's Committee for Medicinal Products for Human Use has recommended that all ranitidine medicines be suspended within the European Union as a result of the presence of low levels of NDMA.


CHMP Recommends Suspension of All Ranitidine Medicines in the EU

Editor of Pharmaceutical Technology Europe

Industry must never become complacent about the safety of drug products and should seek to continually perform surveillance even if the drug is well-established.


Complying Confidently? Learning Lessons from Nitrosamine Impurities

Agnes Shanley is senior editor of Pharmaceutical Technology.

Discovery of carcinogenic nitrosamines in three of the world’s most widely prescribed drugs is driving efforts to better detect, control and prevent their generation in APIs and finished drug products.


Contamination Drives a More Concerted Approach to Genotoxins

Pramote Cholayudth previously was the managing director of the Professional Conference Center, Ltd. He currently is a validation consultant to Biolab Co., Ltd., in Thailand. He is the founder and manager of PM consult, cpramote2000@yahoo.com.

Lei Lei is senior R&D director of Cutia Therapeutics, Shanghai, China, and he was principal scientist of Shanghai Johnson & Johnson Pharmaceutical Company

The CuDAL-Excel program, based on Microsoft (MS) Excel, has been developed to calculate the United States Pharmacopeia (USP) passing probability of content uniformity and dissolution tests for both sampling plan 1 and sampling plan 2 scenarios and for both immediate release and extended release requirements. The users can obtain the passing probability by simply entering the input variables, with wide applications for process validation/verification and batch release. As a user-friendly program, CuDAL‑Excel should bring more benefits to the industry practitioners than other existing programs/tools.


Determining the Probability of Passing USP Content Uniformity and Dissolution (Immediate and Extended) Tests with CuDAL-Excel

The ASTM standard describes how to evaluate single-use systems for foreign particle analysis. 

New ASTM Standard Addresses Foreign Particles in Biomanufacturing Processes

Chris Moreton is principal, FinnBrit Associates

Priscilla Zawislak is global regulatory affairs advocacy manager, DuPont

Katherine L. Ulman is principal, KLU Consulting

Luke Grocholl is regulatory affairs expertâpharma food materials, MilliporeSigma

With ingredients sold to multiple markets, excipient manufacturers must understand the different regulatory requirements for pharma vs. food.

Comparison of Pharmaceutical Excipients and Food Ingredient Requirements

USP technical advisors will offer assistance to drug developers to ensure material quality and testing.

USP Offers Support for COVID-19 Drug Developers

This article details the more operational aspects of monograph submissions, answering the question of how to participate.

Compendial Compliance