Microbial Examination of Nonsterile Products: Microbial Enumeration Tests USP <61> Q. Can I use strains other than those that are cited in the USP? A. You should use the strains that are cited in this chapter or equivalent strains from other culture collections. For example, if Pseudomonas aeruginosa ATCC 9027 is indicated, you should use this strain or strains … [Read more...]
FDA CBER STERILITY TESTING REQUIREMENTS (610.12) AMENDED (06/04/12)
ELIMINATES SPECIFIED STERILITY TEST METHODS, CULTURE MEDIA FORMULAE, AND CULTURE MEDIA TEST REQUIREMENTS -- CLARITY OR CONFUSION? Summary (Effective June 4, 2012) The Food and Drug Administration (FDA) is amending the sterility test requirements for biological products. This rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages … [Read more...]
Burkholderia cepacia: This Decision Is Overdue
FDA Believes Now is the Time to Remove the Bug from Pharmaceutical Manufacturing The FDA recently published an article wherein they discuss the rationale for removing B. cepacia from the pharmaceutical arena. They cite a number of reasons why they believe that this bacterium and its variants should no longer be permitted. These discussions are … [Read more...]
