This is Chapter 4 of Valutek's Technical Paper Series:
Navigating Cleanroom Standards: A Comprehensive Guide to Organizations, Regulations, and Associations
Navigating Cleanroom Standards: A Comprehensive Guide to Organizations, Regulations, and Associations
Overview
The life sciences industry—including pharmaceuticals, biotechnology, and medical device manufacturers—relies on rigorous standards and continuous education to ensure contamination control and compliance. This chapter introduces key non-profit scientific organizations and trade associations that support these efforts.
By the end of Chapter 4, you will learn:
- The role of the United States Pharmacopeia (USP) in setting quality standards for medicines and compounding.
- How the Parenteral Drug Association (PDA) advances pharmaceutical manufacturing science and regulation.
- The global impact of the International Society for Pharmaceutical Engineering (ISPE) on manufacturing and regulatory practices.
- Major trade shows and educational events like INTERPHEX and MD&M that provide training and networking opportunities.
“Life sciences associations are pivotal in shaping standards and offering education that empowers cleanroom professionals to maintain compliance and quality.”
– Jan Eudy, Cleanroom Subject Matter Expert