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IG Event Overview
Event Date: Tuesday 08 October
IG Co-Leads Igor Gorsky (Valsource) and Paolo Curto (DOC, A Masco Group Company) are pleased to announce the next IG meeting featuring panelist Tony Cundell (Microbiological Consulting, LLC).
Topic
Recent Warning Letters that are requesting that manufacturers to set limits and specifications for objectionable microorganisms in their purified water. USP <1231> sets limits for TAMC of NMT 100 cfu/mL but does not address objectionable microorganisms. The GMP regulations require that objectionable organism be excluded from non-sterile drug products but not necessarily pharmaceutical ingredients.
IG members will discuss the following question: As Gram-negative, oxidase-positive bacteria would be the normal microflora of water, what would be excluded?
Interest Group Leaders
Igor Gorsky
Paolo Curto
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