Read, Learn, Innovate: Top Blog Posts from June 2022
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from June 2022. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
ISPE Paperless Validation Sub-Committee Established
Paperless Validation is a current topic of interest within the pharmaceutical industry with many companies now adopting or planning to adopt paperless solutions with the promise of improved data integrity and significant efficiency improvements to their existing paper-based validation processes.
Women in Pharma® Member of the Quarter: Gaelle Saint-Louis
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 Pharma committee.
Contrasting Drug Substance and Drug Product Continuous Manufacturing
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 perspective.
Manufacturing Trends in the Pharmaceutical Industry
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 in the future.
The Single-Use Technology Supply Crisis: Round-Table Discussion Summary
The exponential increase in demand to manufacture therapeutics including vaccines triggered by the pandemic has stressed the supply chain for single-use products.
