ASEPTIC PROCESSING OF STERILE PHARMACEUTICALS, BIOLOGICALS, AND MEDICAL DEVICES

摘要

Farquharson has published an article which identifies three key players in establishing advisories and guides in carrying out the aseptic manufacturing process: EU GMP Annex I, ISO 14644-1, and FDA Aseptic Guidance—Is this a Good Basis for an International Sterile Products GMP1 The author is a respected authority with exemplary service in the area of production of aseptically processed Pharmaceuticals. The primary intent in citing this 2004 publication by Farquarson is the recognition that some measure of concordance or harmonization in the above-mentioned guidances is overdue to offer the global aseptically produced Pharmaceuticals manufacturer a stationary target for defining the viable and total environmental criteria "appropriate" for aseptic processing. One of the areas of contention between ISO 14644-1 and EU GMP-Annex 1 compared to USP chapter 1116 and the 2004 FDA draft guide on Aseptic Processing is the distinction of the at-rest mode vs. operational conditions. As if the alphabetical vs.numerical cleanliness designations weren't enough to confuse the aseptic processing manufacturer, the further distinctions between at-rest and operational modes should assure consternation for the global manufacturer. In addition to the three major sources of guidance enumerated in the publication title, the article also condescends to mention the USP informational chapter 1116, Microbiological Control and Monitoring Environments Used for the Manufacturing of Health Care Products. (USP PF, March-April2005) which pursued these criteria since 1991. Another important player overlooked in the Farquarson article is the Japanese Pharmacopeia (JP).