ValSource Chief Operating Officer Hal Baseman Co-Chair
September 27, 2016
ValSource, LLC (“ValSource”), announced, Hal Baseman as Co-Chair of the Parenteral Drug Association (“PDA”) Aseptic Processing Task Force will present on subjects related to Aseptic Process design and simulation at upcoming PDA workshops in Dublin Ireland on October 5-6, 2016 and Arlington VA on 25-26, 2016. The PDA convened the task force revised the 2003 PDA-published paper, “Points to Consider for Aseptic Processing.” Originally drafted as a commentary on the U.S. FDA guidance on GMPs for aseptic processing, the 2003 document was rendered obsolete by considerable changes within the industry resulting in additional knowledge, including new regulatory guidance in this area.
This task force’s revision comes at a time when regulatory health authorities, most notably the PIC/S are updating or developing regulations and guidelines in the area of sterile manufacturing.
The basis for the PDA revision encompassed five related regulatory goals: 1) Use of science and risk-based approaches; 2) Application of modern technology; 3) Reevaluation of traditional control strategies; 4) Consideration of new product/container presentations; and 5) Harmonization of global regulatory expectations. Hal Baseman commented, “This important work is an effort to modernize approaches to sterile product manufacturing, taking into account changes and knowledge gained over years of aseptic product manufacturing. The work of the task force is not yet finished, but the first steps are substantive, necessary and completely forward thinking.”