ISPE GAMP® has led the way in computerized systems best practices for more than 30 years. GAMP brought us the concept of system lifecycles and leveraged the V-model to give us a structured approach to computerized systems validation (CSV). GAMP developed and adopted the risk-based approach to CSV, enabling industry to focus validation efforts on critical systems and functionality.
For nearly a century, production of Water for Injection (WFI) was universally accepted to be distillation-based. As emphasis on costs and environmental concerns has grown, pharmacopeias around the world have focused on the quality attributes of WFI to allow for consideration of other production technologies. In 2017, the European Pharmacopoeia joined the US, Japan, and many other regulatory...
Following an unprecedented two years in which the pharmaceutical industry has faced numerous challenges posed by the global pandemic, pharmaceutical manufacturing has had to react and respond to meet the rapidly changing requirements and timelines. This has necessitated a radical rethink in how we approach pharmaceutical manufacturing and how we meet the expectations of the market and patients...
Continuous manufacturing (CM) is gaining traction in pharmaceutical manufacturing. The purpose of this post is to highlight some of the differences between small molecule Drug Substance (DS) and Drug Product (DP) continuous manufacturing (CM), which may be helpful in considering the development and execution of CM for pharmaceutical manufacturing. The following are the key differences from our...
Gaelle Saint-Louis is the Women in Pharma® (WIP) Chair of the ISPE San Diego Chapter. She began her involvement with ISPE as the Young Professional (now Emerging Leaders) Chair for the Greater Los Angeles Chapter in 2019. After relocating to San Diego, she took on a leadership role within the Chapter's Women in...
