ISPE is dedicated to keeping our members up to date on the latest news and resources about COVID-19 and the ways the pharmaceutical industry is adapting to ongoing developments. One valuable resource is the Food and Drug Administration’s (FDA) question-and-answer-post, Manufacturing, Supply Chain, and Drug Inspections (COVID-19), which provides guidance on how to implement manufacturing and site changes as well as reporting to an application. The Center for Drug Evaluation and Research (CDER) is continuing drug reviews while responding to public health needs associated with the COVID-19 outbreak while the FDA continues to be adaptable and transparent.
This valuable resource covers how inspections are going to be affected due to COVID-19 and includes information on:
During this time of uncertainty, it is more important than ever that the pharmaceutical industry be able to continue research as well as manufacturing and distribution. ISPE is here to support our members, help them continue their quest for knowledge, and provide them with ways to stay connected. Our COVID-19 (Coronavirus) Pharma Industry Resources Page has a complete list of global and local resources available to you including articles, webinars and links to industry information.
The pharmaceutical industry stands at the cusp of a transformative era, where the integration of sustainability within the supply chain is not just a trend, but a necessity. The 2024 ISPE Annual Meeting &...
Although parenteral products make up only 1% of global pharmaceutical prescriptions by volume, at list price they now make up nearly half of global sales value, a percentage that has been increasing. Many of these are complex products produced in smaller batches for immunology or oncology, and a large majority are biologic therapies, which are generally poorly suited to oral formulations.
In 2020, CSL initiated a benchmarking activity with a small group of peer companies identified through ISPE to explore creation and maturation of asset management programs at each company. The initial sessions were a success, covering topics such as asset condition evaluations and asset management governance. CSL was keen to continue the conversations and gather more insights on certain...