Cover: Women in Pharma® is a place where women and men—especially those new to the industry—can access a network of mentors, role models, and educational resources to support their professional success. The widespread global interest and participation in this initiative and its events have shown that women in the pharmaceutical industry are hungry for the connection, mentoring, and education that Women in Pharma offers.
Feature: A standard operating procedure outlines agreed-upon instructions for personnel training and instructions for maintaining systems, machines, documents, and records in a qualified state to produce safe products. This article explores the role of SOPs, as well as their structure and components.
How can drug developers increase the efficiency and effectiveness of drug development? One useful tool is model-informed drug development, which uses computer models to inform the design of clinical trials or to run simulations when human or animal trials are not feasible. By ensuring that appropriate drugs are advanced and the clinical trial design is optimized, MIDD helps drug companies develop therapies for emerging diseases like COVID-19.
Feature: ISPE has announced the launch of its Advancing Pharmaceutical Quality Program with the publication of the ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System, a guide dedicated to the topic of CAPA. This article describes how the APQ Program has been built and summarizes the content covered in the Advancing Pharmaceutical Quality Guide series, using the CAPA guide as an example.
Technical: Recently, recalls of angiotensin receptor antagonists, particularly valsartan, and warning alerts about N-nitrosodimethylamine impurities in drug substances such as ranitidine and metformin have demonstrated the urgent need for manufacturers and regulators to control impurities throughout the product life cycle to ensure patient safety. This article discusses all plausible pathways related to the formation of NDMA impurities in pharmaceutical products and a possible control strategy using quality risk management as a tool.