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The Advisories were converted into electronic
format by Richard Reich, A.T. of the Saskatchewan Research Council, 15
Innovation Blvd., Saskatoon,
Saskatchewan, Canada S7N 2X8 (Reich@src.sk.ca). Richard also developed
the Contents and Keyword Indices to the Advisories. The documents were
converted into html by Michael E. Mispagel, Ph.D., College of Veterinary
Medicine, The University
of Georgia, Athens, GA 30602-5706 (Mispagel@vet.uga.edu).
Click here for the Keyword
Index starting midway in this document.
Contents Index
Advisory number // Contents
1 Solubility studies, Test substance characterization,
computer validation
2 Exploratory studies, Master Schedule,
Sample retention
3 QAU inspection schedule, Range finding studies, screening
studies
4 Compliance vs. Science, quality, integrity, Multiple
sites, Multiple Study Directors, Test Facility
5 Test substance storage container retention
6 Definitions, study, study director, residue studies,
environmental fate studies
7 Sample retention, archives, dissipation studies,
QAU verification
8 Definitions, Study, Study Director,
Contract Labs
9 QA Verifications, compliance statement, Sponsor,
Study Director, signature Metabolites, reference standards,
Protocol
10 Test Substance storage, characterizations distributions,
synthesis
11 GLP Requirements for Weather Data, Soil Analysis,
Reference to Non-GLP Data
12 Raw Data Archive, Timing, Location, Study Director
Signature on Final Report
13 QAU Inspection Frequency, Field Studies, Multiple
Sites
14 Research vs. Regulatory Study, Exploratory
Studies
15 QAU Duties, Study Director Duties, Contract Laboratory,
QAU Reporting
16 Study Duration
17 Sponsor QAU vs. Testing Facility QAU, Compliance
Responsibility Based in 1983 GLP
18 Multiple Study Protocols, SEP vs.
GLP
19 Scheduling of Lab Audits, Useless
Advisory
20 Multiple Study Directors
21 Test substance mixture storage
22 Multiple Study Directors
23 Test Substance Stability, Storage
Conditions
24 Test Substance Storage Container
Retention, Disposal
25 Test Substance Storage Container
Retention, Disposal
26 Test Substance Storage Containers
Retention, Disposal
27 Test Substance Storage Container
Retention
28 GLP Requirements for Efficacy Studies
29 Analytical Methods
30 Mixture of Substances with Carriers
31 Raw Data Archive, Final Report Compliance Statement,
Study Director
32 Test Substance Storage Containers
Retention
33 Method Validation, Analytical Lab
34 QA Statement, Subcontractors Report, QA Reports,
Audit Requirements
35 Specimen Disposal, Petri Dish, Quality Assurance
Verifications
36 Quality Assurance verification
37 Test Substance Storage Container Retention, Intermediate
Containers, Rail Cars
38 Archive Responsibility, QAU
39 Generic Protocol, Sponsor Approval, Study Director
Signature
40 Test Substance Storage Container
Retention
41 Test Substance Storage Container Retention, Gas
Cylinder
42 Archives, Final Report Signatures, Study Director
Responsibilities
43 Multiple Field Sites, Multiple Studies
44 Raw Data Archives, Certified Copies
45 Test Substance, Treated Seed
46 Testing Facility Management, Subcontractors, Management
Duties, Field Cooperators, Field Sites, Management
Companies Relationships
47 Raw Data, Carbon Copy
48 QAU Duties and Qualifications, Memberships
49 Drafting Protocols, Reporting Study Results, Multiple
Test Substance, Multiple Sponsors
50 Sample Disposal, Sample Retention, Fungal Bacterial
Cultures, Specimens, Test Substances
51 Test Substance Storage Container
Retention
52 Test Facility Management, Study Director, QAU,
Husband, Wife
53 Study Director Signature of Final
Report
54 Sample Disposal, Sample Retention, Analytical Standard
Retention
55 Analytical Analysis GLP Requirements, Test Substance
Container Retention, Bulk Containers, Analytical
Method Validation
56 Test Substance container retention,
exemption
57 Raw Data retention from superceded studies, cancelled
studies
58 GLP requirements for IR-4 studies,
minor use studies
59 Study Director, Management, relationship, External
QAU, Protocol approval, Protocol amendment approval
60 Test substance storage container
retention
61 Wet specimen retention, sample storage
62 Test Substance storage, use, temperature
monitoring
63 Test Substance storage container
retention
64 Test Substance characterization, radio-labelled
test substances
65 Test Substance Characterization
66 QAU independence, 52 vs. 59, Study Director, Management
relationship
67 Test Substance Storage Container
retention waiver
68 QAU reporting of inspections, Study Director, management
relationship
69 (Not released to public)
70 Final reporting of invalid test results, protocol
amendments
71 GLP compliance statement, final report, study termination,
late discovery of non-compliance issues,
compliance statement amendment
72 Management, owner, technician, QAU
relationships
73 Study Director, contract laboratory
74 Storage containers
75 Archives, EPA notification
76 TSCA, Data retention
77 Storage stability studies
Top of Contents Index
Return to the Quality Assurance Home
Page
Keyword Index
Advisory 52 vs. Advisory 59, 66
Analytical analysis GLP requirements 55
Analytical lab 33
Analytical method validation 55
Analytical methods 29
Analytical standard retention 54
Archive responsibility 38
Archives 7, 42, and 34
Bulk containers 55
Cancelled studies 57
Carbon copy 47
Certified copies 44
Characterizations distributions 10
Compliance statement 9
Compliance statement amendment 71
Compliance responsibility based in 1983 GLP 17
Compliance vs. Science 4
Computer validation 1
Contract laboratory 15, 73
Contract labs 8
Data retention 76
Definitions 6, 8
Disposal 24, 25, 26
Dissipation studies 7
Drafting protocols 49
Environmental fate studies 6
EPA notification re. archives 56
Exploratory studies 2, 14
External QAU 59
Field cooperators 46
Field sites 46
Field studies 13
Final report 71
Final report compliance statement 31
Final report signatures 42
Final reporting of invalid test results 70
Fungal bacterial cultures 50
Gas cylinders 41
Generic protocol 39
GLP compliance statement 71
GLP requirements for IR-4 studies 58
GLP requirements for efficacy studies 28
GLP requirements for weather data 11
Husband 52
Integrity 4
Intermediate containers 37
Late discovery of non-compliance issues 71
Location 12
Management 59, 72
Management companies relationships 46
Management duties 46
Management relationship 66, 68
Master schedule 2
Memberships 48
Method validation 33
Minor use studies 58
Mixture of substances with carriers 30
Multiple field sites 43
Multiple sites 4, 13
Multiple sponsors 49
Multiple studies 43
Multiple study directors 4, 20, 22
Multiple study protocols 18
Multiple test substance 49
Owner 72
Petri dish 36
Protocol 9
Protocol amendment approval 59
Protocol amendments 70
Protocol approval 59
QA reports 34
QA statement 34
QA verifications 9
QAU 38, 52
QAU duties 15
QAU duties and qualifications 48
QAU independence 66
QAU inspection 3
QAU inspection frequency 13
QAU relationships 72
QAU reporting 15
QAU reporting of inspections 68
QAU verification 7
Quality 4
Quality assurance verifications 36
Radio-labelled test substances 64
Rail cars 37
Range finding studies 3
Raw data 47
Raw data archives 12, 31, 44
Raw data retention from superceded studies 57
Reference standards 9
Reference to non-GLP data 11
Relationship 59
Reporting study results 49
Research vs. regulatory study 14
Residue studies 6
Sample disposal 50, 54
Sample retention 2, 7, 50, 54
Sample storage 61
Schedule 3
Scheduling of lab audits 19
Screening studies 3
SEP vs. GLP 18
Signature metabolites 9
Soil analysis 11
Solubility studies 1
Specimen disposal 36
Specimens 50
Sponsor 9
Sponsor approval 39
Sponsor QAU vs. testing facility QAU 17
Storage conditions 23
Storage stability 77
Study 6, 8
Study director 6, 8, 9, 31, 52, 59, 66, 68, 73
Study director duties 15
Study director responsibilities 42
Study director signature 39
Study director signature on final report 12, 53
Study duration 16
Study termination 71
Subcontractors 46
Subcontractors report 34
Synthesis 10
Technician 72
Temperature monitoring 62
Test facility 4
Test facility management 52
Test substance 45
Test substance characterization 1, 64, 65
Test substance container retention 55, 56
Test substance mixture storage 21
Test substance stability 23
Test substance storage 10, 62
Test substance storage container retention waiver 67, 74
Test substance storage container retention 5, 24, 25, 26, 27, 32, 37, 40, 41, 51, 60, 63, 74
Test substances 50
Testing facility management 46
Timing 12
Treated seed 45
TSCA 76
Use 62
Wet specimen retention 61
Wife 52
Top of Contents Index
Top of Keyword Index
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