It is also an apt description of the three-decade history of isolator technology in the pharmaceutical industry. Slow-walking is a contemporary term that describes the purposeful delay of the approval of political appointees. It is really beyond the time when we should be paying attention to these guys. They provide more detail than I have and make an even more compelling argument.
It is written by three friends who also happen to be among the world’s most respected authorities on the subject. Lest the reader presume that I am alone in my thinking or that I am an emerging pioneer in the application of advancing the state of aseptic processing, I offer the following paper. My frustration reached a venting point with an article titled The State of Aseptic Processing: Let’s Get Serious. Throughout that effort I faced a personal struggle with having to deal with requirements based upon manufacturing technologies dating back over 40 years. By James Akers, James Agalloco, and Russell Madsenįor the past 12 to 18 months, I have been part of a PDA committee constructing responses to two versions of the proposed revision to Annex 1 for Manufacture of Sterile Medicinal Products.
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