This valuable resource covers how inspections are going to be affected due to COVID-19 and includes information on:
What types of inspections are considered mission critical
How to add or change a facility in an application due to pandemic-related supply chain disruptions
What data is required to support a manufacturing process or facility change
How to file an application that includes facilities in regions affected by pandemic travel restrictions
The FDA’s response to applications including facilities that cannot be inspected due to travel restrictions
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 topic of continuous manufacturing has drawn considerable interest across all modalities of pharmaceutical manufacturing. Thus far much of the progress has been seen in small molecule drug product manufacturing platforms where multiple products have...
The design, construction, commissioning, qualification, and continued performance of water and steam systems for the pharmaceutical industry present significant challenges. These systems need to meet Good Manufacturing Practice (GMP) regulations...