Rubrik: GxP
(Treffer aus pharmind, Nr. 08, Seite 762 (2024))
Röder F | Neumann S
The new ISPE Guide on Process Gases / Röder and Neumann | ISPE Guide on Process Gases · Röder F, Neumann S · Merck Healthcare und Boehringer Ingelheim Corporate Center
Compressed Air Clean Gases GMP ISPE Sustainability The idea to update the ISPE Good Practice Guide on Process Gases ( fig. 1 ) came up within the ISPE Critical Utilities CoP Steering Committee. Like it is common for a pharmaceutical facility and its standard operating procedures (SOPs), ISPE guides are periodically reviewed in order to verify if they are still current, valid and still describing the state-of-the-art technology. This process exactly happened in 2022 for the “Gas Guide”, and it was concluded that a revision was advisable for several reasons. Once such a revision starts, it is good practice to not ...