Microbial Contamination

Preferred Label : Microbial Contamination;

NCIt related terms : Microbiological;

Alternative definition : FDA: The undesirable presence of microorganisms or microbes such as bacteria and fungi (yeasts and molds).; PQCMC: Microorganism contamination of the cell culture or starting/raw materials that are objectionable due to their detrimental effect on products or potential harm to patients or due to the total number of organisms. [Source: 21CFR211 Preamble]. Examples: bacteria, fungi, mollicutes (mycoplasmas or spiroplasmas), mycobacteria, rickettsia, protozoa, parasites, agents causing TSEs and viruses.;

Codes from synonyms : 3218;

Details

Origin ID

C92081;

UMLS CUI

C2984813;

Manual BTNT mappings - CISMeF
- Product contamination microbial [MedDRA Preferred Term]
Semantic type(s)
- Finding [UMLS semantic type]
concept_is_in_subset
- CDRH Cause Investigation - Investigation Findings Terminology [NCIt concept]
- FDA Center For Devices and Radiological Health Terminology [NCIt concept]
- FDA Pharmaceutical Quality/CMC Terminology [NCIt concept]
- PQ/CMC Impurity Classification Terminology [NCIt concept]

Keyword's position in hierarchy(ies) :

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