Project Engineering and Good Manufacturing Practices (GMP)

Project Engineering within the Life science industry offers an evergreen area for Engineers of many disciplines. Projects large and small form part of the endless cycle of continuous improvement within manufacturing, line modification and repurposing, new production introductions, equipment and process changes. Project engineers support various projects that arise and call on additional or dedicated engineers to implement changes.This short book takes a number of common areas applicable to Project Engineers working in GMP environments. Good Manufacturing practices are the key ingredient for execution projects in medical device, pharmaceutical and biologics companies. A core curriculum of GMP is introduced in this book:Units and MeasurementBasic StatisticsGood Manufacturing PracticesData Integrity FacilitiesUtilitiesSterile Manufacturing ValidationCleaning Validation