USP <1111> Microbiological Examination of Nonsterile Products
GPTKB entity
Statements (22)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
pharmacopeial standard
|
| gptkbp:appliesTo |
nonsterile drug products
nonsterile raw materials |
| gptkbp:describes |
test methods for total combined yeasts and molds count
acceptable microbial limits test methods for total aerobic microbial count tests for specified microorganisms |
| gptkbp:focusesOn |
microbiological quality of nonsterile pharmaceutical products
|
| gptkbp:guidanceSystem |
microbial limits testing
|
| https://www.w3.org/2000/01/rdf-schema#label |
USP <1111> Microbiological Examination of Nonsterile Products
|
| gptkbp:language |
English
|
| gptkbp:latestReleaseVersion |
USP 43-NF 38 (2020)
|
| gptkbp:partOf |
gptkb:United_States_Pharmacopeia_(USP)
|
| gptkbp:publishedBy |
United States Pharmacopeial Convention (USP)
|
| gptkbp:referencedIn |
gptkb:Good_Manufacturing_Practice_(GMP)_regulations
FDA guidelines |
| gptkbp:relatedTo |
USP <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests |
| gptkbp:usedBy |
pharmaceutical manufacturers
quality control laboratories |
| gptkbp:bfsParent |
gptkb:USP_Microbiology_Standards
|
| gptkbp:bfsLayer |
7
|