USP <1116> Microbiological Control and Monitoring of Cleanrooms
GPTKB entity
Statements (23)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:pharmaceutical_guideline
|
| gptkbp:appliesTo |
controlled environments
cleanrooms |
| gptkbp:focusesOn |
environmental monitoring
microbiological control |
| gptkbp:guidanceSystem |
risk-based approach
alert and action levels interpretation of microbiological data microbial monitoring procedures |
| gptkbp:language |
English
|
| gptkbp:latestReleaseVersion |
2022
|
| gptkbp:publishedBy |
gptkb:United_States_Pharmacopeia_(USP)
|
| gptkbp:recommendation |
investigation of excursions
routine environmental monitoring trend analysis of microbial data |
| gptkbp:relatedTo |
gptkb:USP_<797>
gptkb:USP_<800> |
| gptkbp:usedBy |
biotechnology industry
pharmaceutical industry compounding pharmacies |
| gptkbp:bfsParent |
gptkb:USP_Microbiology_Standards
|
| gptkbp:bfsLayer |
7
|
| https://www.w3.org/2000/01/rdf-schema#label |
USP <1116> Microbiological Control and Monitoring of Cleanrooms
|