There are countless aging pharma manufacturing facilities around the world that continue to operate on the edge of regulatory failure. They continue limping along for years, squeezing through audits based on extensive data reviews and the application of increased procedural controls. While the need to upgrade, or replace these facilities may be clear to those that operate them every day, teams often find it difficult to receive the significant capital approval to bring the facility up to today’s regulatory standards. If you are responsible for, or work in such a facility, and are looking for some tools and guidance to make facility or equipment improvements, this session is for you.
This session is the next installation of the “Is Your Facility on Borrowed Time” series brought to you by the ISPE Sterile Products Processing Community of Practice. In this interactive session, you will learn how to assess different options for upgrading a legacy sterile manufacturing facility (e.g., transfer to alternative asset, retrofit in place, build adjacent, build greenfield), and determine how to get the most “Bang for your buck” given fixed capital allocation.
The presentation will discuss decision points and implications of each option, and will include an evaluation of the options against a business case framework to make a robust recommendation to leadership.