Giles Scientific includes Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) validation documents with each TRINITY V3 purchase. These documents comply with 21 CFR Part 11 (Code of Federal Registry), Association of Analytical Communities (AOAC), Good Laboratory Practice (GLP) standards, and US-FDA Bacteriological Analytical Manual (BAM). Validation protocols may be customized to meet each laboratory's unique certification requirements.
Antibiotic Potency Assays as Described in USP Chapter 81
"Antibiotic Potency Assays as Described in USP Chapter <81>" article by David L. Gibbs Ph.D. ABMM, available at: http://www.microbiologyforum.org/PMFNews/PMFNews.14.07.0807.pdf
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