San Diego, Ca., April 19, 2016 – The Parenteral Drug Association, Inc. (PDA) opened its two-day workshop on current challenges in aseptic processing with a challenge to the younger attendees to question “why and why not” in regard to the way their companies manufacture sterile drug products. PDA’s volunteer leadership has led the pharmaceutical and biopharmaceutical industry in innovating manufacturing and control for sterile production and filling operations.
The workshop is the first in a series of four that PDA is sponsoring in 2016 to generate information on current practices in aseptic operations in anticipation of commenting on the European Medicines Agency’s revision to its GMP guidance for sterile drug products, Annex 1.
“Aseptic processing really hasn’t materially changed all that much in 38 years,” observed PDA Immediate-Past-Chair Hal Baseman (ValSource) during his opening remarks. “I really would like to see you, a young group of people moving this industry forward.”
The goal of the workshop series is to generate information on current best practices via breakout discussions and a survey that will be taken at each location.
Baseman was followed on the podium by a number of experts who discussed various aspects of good aseptic processing practices and PDA’s 2015 Points to Consider for Aseptic Processing. Headlining these was Thomas Arista, a U.S. FDA national expert investigator in pharmaceutical and biotechnology, who provided a regulatory perspective on the topic.
The next two-day workshop takes place in Berlin, May 31-June 1.