I am specially looking if someone can provide me the detail guidelines for qualitative and quantitative interpretation of microbiological test in pharmaceutical area . Any guidelines, comments, recommendation are highly appreciated.
Phil and Jacob I am looking for both. I looked over the interpretation guidelines provided by USP, AOAC and many articles but I found different in interpretation mostly in quantitative. I am just curious about the practice of both result interpretation in analytical lab focused on microbiology.
For AET, the differences are regional. USP 51 and EP5.1.3 are controlling and, as you saw, EP is more demanding in rate and extent of kill. Region chosen for marketing will determine to which you comply - but compliance can be negotiable with regulatory agencies with valid technical arguments. Here's an older comparison (efforts at harmonization may have changed some) and you might look for articles by Scott Sutton - Article Comparison of Compendial Antimicrobial Effectiveness Tests: A Review
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