ISPE Releases ISPE Good Practice Guide

The Inter­na­tion­al Soci­ety for Phar­ma­ceu­ti­cal Engi­neer­ing (ISPE) announced the release of its lat­est guide, ISPE Good Prac­tice Guide: Crit­i­cal Util­i­ties GMP Com­pli­ance – How to Be Com­pli­ant and Ready to Prove It. The Guide was cul­ti­vat­ed by lead­ing experts to help phar­ma­ceu­ti­cal orga­ni­za­tions achieve and main­tain their crit­i­cal util­i­ty sys­tems in a state of con­trol, and then be able to effi­cient­ly demon­strate their sys­tems’ Good Man­u­fac­tur­ing Prac­tice (GMP) com­pli­ance to reg­u­la­to­ry inspec­tors and auditors.

“This Guide will be a big ben­e­fit to crit­i­cal util­i­ty pro­fes­sion­als and small­er man­u­fac­tur­ing facil­i­ties where they don’t have as much bench depth in their com­pli­ance depart­ments,” said Nik Krpan, Pres­i­dent, Cheme Engi­neer­ing, Guide co-lead. “This resource will help them to iden­ti­fy what are the crit­i­cal areas they should be focus­ing on to achieve com­pli­ance for their crit­i­cal util­i­ties and how to host a more effi­cient audit.”

Key areas addressed in the Guide include:

• Water sys­tems
• Pure steam
• Com­pressed air
• Med­ical gases
• Process­es unique to crit­i­cal utilities