A NEW PROPOSED USP GENERAL INFORMATION CHAPTER
USP recently released a new DRAFT in a much anticipated area that has gained significant attention over the past half dozen years. The subject, “USP<1115> Bioburden Control of Nonsterile Drug Substances and Products”, has generated much controversy as nonsterile manufacturers have repeatedly asked the question “what degree of microbial cleanliness should I require with my nonsterile drug substances and products” and “how many microorganisms of a single genus may I have where USP<1111> has limits of either 100 or 1000 per gram”?  Efforts have been made to historically determine these questions within other USP Chapters to include USP<61>, USP<1111> and USP<1231> which have addressed both test methodologies and microbial counts allowed. 21 CFR 211 has also “weighed into” this fray with their various regulations, but have not offered solutions. Quite often during lectures and seminars, the comment is overheard “With sterile products, it was so much simpler to provide a microbial answer” because I have definitive endpoints.
This DRAFT approaches nonsterile drug substance and bioburden control from a Risk Management perspective (ICH Q9). It compares considerations of excessive cost and complexity vs. added value to the consumer and the product. The DRAFT also provides microbial control considerations in an array of microbiological control areas to include manufacturing, equipment design, personnel and the overall management of a nonsterile microbiological control program.
This DRAFT may be obtained by going to the most recent posting of Pharmacopeial Forum and/or attending a Tungsten Shield webinar on Thursday, August 15.
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