There are a number of areas where interpreting published information and applying it in the real world has proven to be problematic.
By James Agalloco
The aseptic process simulation (or media fill test) has been a compliance expectation for aseptic processing operations since the 1980s. Industry guidance from the Parenteral Drug Association (PDA), Pharmaceutical and Healthcare Sciences Society (PHSS), International Standards Organization (ISO), Food and Drug Administration (FDA), European Medicines Agency (EMA) and Pharmaceutical Inspection Cooperation/Scheme [PIC/S] regulatory outlines have endeavored to establish the “what” and “how” of their execution. The PDA’s latest guidance outlined the subject in a comprehensive manner addressing all of the major elements of the simulation design and execution.7 It might be expected that given the extent of the available content, that no controversies or confusion would exist regarding process simulations. Unfortunately, that is not the case. There are a number of areas where interpreting the published information and applying it in the real world has proven to be problematic.
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