Whether part of a full-service EPCMV project or as a standalone service, IPS’ compliance SMEs facilitate a Quality by Design (QbD) process to assure facilities and processes are designed in accordance with CGMPs.  

Although risk assessments have been in the industry for many years, formally documented risk assessments have become a regulatory expectation and QMS requirement, especially within aseptic and high potency product manufacturing facilities. Risk assessments should be performed to identify, assess, control, monitor, detect, and wherever possible eliminate risks. Risk assessments provide the most value when performed early in the design process, so identified risks can be mitigated and/or removed in the design.