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gptkbp:instanceOf
|
gptkb:United_States_federal_law
|
|
gptkbp:appliesTo
|
pharmaceuticals
biologics
color additives
food additives
medical devices
animal food additives
nonclinical laboratory studies
pesticide chemicals
|
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gptkbp:citation
|
gptkb:21_CFR_58.1
gptkb:21_CFR_58.10
gptkb:21_CFR_58.190
gptkb:21_CFR_58.195
gptkb:21_CFR_58.200
gptkb:21_CFR_58.3
gptkb:21_CFR_58.35
|
|
gptkbp:codifiedIn
|
gptkb:Title_21_of_the_Code_of_Federal_Regulations
|
|
gptkbp:enforcedBy
|
gptkb:U.S._Food_and_Drug_Administration
|
|
https://www.w3.org/2000/01/rdf-schema#label
|
21 CFR Part 58
|
|
gptkbp:purpose
|
ensure quality and integrity of safety data submitted to FDA
|
|
gptkbp:regulates
|
gptkb:Good_Laboratory_Practice_for_Nonclinical_Laboratory_Studies
|
|
gptkbp:requires
|
study protocols
equipment maintenance
personnel training
standard operating procedures
final reports
archiving of records
proper recordkeeping
quality assurance unit
|
|
gptkbp:section
|
gptkb:Subpart_A_-_General_Provisions
gptkb:Subpart_B_-_Organization_and_Personnel
gptkb:Subpart_F_-_Test_and_Control_Articles
gptkb:Subpart_G_-_Protocol_for_and_Conduct_of_a_Nonclinical_Laboratory_Study
gptkb:Subpart_J_-_Records_and_Reports
gptkb:Subpart_K_-_Disqualification_of_Testing_Facilities
Subpart C - Facilities
Subpart D - Equipment
Subpart E - Testing Facilities Operation
|
|
gptkbp:startDate
|
1978
|
|
gptkbp:website
|
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-58
|
|
gptkbp:bfsParent
|
gptkb:Good_Laboratory_Practice
|
|
gptkbp:bfsLayer
|
6
|