Good Laboratory Practice for Nonclinical Studies
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Good Laboratory Practice for Nonclinical Studies
Bunn, Graham P.
Taylor & Francis Ltd
10/2024
194
Mole
9781032381152
Pré-lançamento - envio 15 a 20 dias após a sua edição
Descrição não disponível.
Introduction
1. Subpart A - General Provisions
i) Sec. 58.1 Scope
ii) Sec. 58.3 Definitions.
iii) Sec. 58.10 Applicability to studies performed under grants and contracts.
iv) Sec. 58.15 Inspection of a testing facility.
2. Subpart B - Organization and Personnel
i) Sec. 58.29 Personnel.
ii) Sec. 58.31 Testing facility management.
iii) Sec. 58.33 Study director
iv) Sec. 58.35 Quality assurance unit.
3. Subpart C - Facilities
i) Sec. 58.41 General.
ii) Sec. 58.43 Animal care facilities.
iii) Sec. 58.45 Animal supply facilities.
iv) Sec. 58.47 Facilities for handling test and control articles.
v) Sec. 58.49 Laboratory operation areas
vi) Sec. 58.51 Specimen and data storage facilities
4. Subpart D - Equipment
i) Sec. 58.61 Equipment design.
ii) Sec. 58.63 Maintenance and calibration of equipment.
5. Subpart E - Testing Facilities Operation
i) Sec. 58.81 Standard operating procedures.
ii) Sec. 58.83 Reagents and solutions.
iii) Sec. 58.90 Animal care.
6. Subpart F - Test and Control Articles
i) Sec. 58.107 Test and control article handling.
ii) Sec. 58.113 Mixtures of articles with carriers.
7. Subpart G - Protocol for and Conduct of a Nonclinical Laboratory Study
i) Sec. 58.120 Protocol.
ii) Sec. 58.130 Conduct of a nonclinical laboratory study.
8. Subpart J - Records and Reports
i) Sec. 58.185 Reporting of nonclinical laboratory study results.
ii) Sec. 58.190 Storage and retrieval of records and data.
9. Subpart K - Disqualification of Testing Facilities i) Sec. 58.200 Purpose.
ii) Sec. 58.202 Grounds for disqualification.
iii) Sec. 58.204 Notice of and opportunity for hearing on proposed disqualification.
iv) Sec. 58.210 Actions upon disqualification.
v) Sec. 58.213 Public disclosure of information regarding disqualification.
vi) Sec. 58.217 Suspension or termination of a testing facility by a sponsor.
vii) Sec. 58.219 Reinstatement of a disqualified testing facility.
10. Data Integrity: Paper and Electronic 21CFR11
1. Subpart A - General Provisions
i) Sec. 58.1 Scope
ii) Sec. 58.3 Definitions.
iii) Sec. 58.10 Applicability to studies performed under grants and contracts.
iv) Sec. 58.15 Inspection of a testing facility.
2. Subpart B - Organization and Personnel
i) Sec. 58.29 Personnel.
ii) Sec. 58.31 Testing facility management.
iii) Sec. 58.33 Study director
iv) Sec. 58.35 Quality assurance unit.
3. Subpart C - Facilities
i) Sec. 58.41 General.
ii) Sec. 58.43 Animal care facilities.
iii) Sec. 58.45 Animal supply facilities.
iv) Sec. 58.47 Facilities for handling test and control articles.
v) Sec. 58.49 Laboratory operation areas
vi) Sec. 58.51 Specimen and data storage facilities
4. Subpart D - Equipment
i) Sec. 58.61 Equipment design.
ii) Sec. 58.63 Maintenance and calibration of equipment.
5. Subpart E - Testing Facilities Operation
i) Sec. 58.81 Standard operating procedures.
ii) Sec. 58.83 Reagents and solutions.
iii) Sec. 58.90 Animal care.
6. Subpart F - Test and Control Articles
i) Sec. 58.107 Test and control article handling.
ii) Sec. 58.113 Mixtures of articles with carriers.
7. Subpart G - Protocol for and Conduct of a Nonclinical Laboratory Study
i) Sec. 58.120 Protocol.
ii) Sec. 58.130 Conduct of a nonclinical laboratory study.
8. Subpart J - Records and Reports
i) Sec. 58.185 Reporting of nonclinical laboratory study results.
ii) Sec. 58.190 Storage and retrieval of records and data.
9. Subpart K - Disqualification of Testing Facilities i) Sec. 58.200 Purpose.
ii) Sec. 58.202 Grounds for disqualification.
iii) Sec. 58.204 Notice of and opportunity for hearing on proposed disqualification.
iv) Sec. 58.210 Actions upon disqualification.
v) Sec. 58.213 Public disclosure of information regarding disqualification.
vi) Sec. 58.217 Suspension or termination of a testing facility by a sponsor.
vii) Sec. 58.219 Reinstatement of a disqualified testing facility.
10. Data Integrity: Paper and Electronic 21CFR11
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
FDA inspections;GLP facilities;FDA code of federal regulations;21 CFR Part 58;Nonclinical Laboratory Studies;Test Article;Control Article;GLP Regulation;Nonclinical Study;GLP Study;Sop Deviation;CFR;QAU;Nonclinical Safety Studies;GLP Compliance;GLP Requirement;Marketing Permit;OECD GLP;Testing Facility Management;Animal Studies;Public Health Service Act;Multisite Studies;Study Director;Animal Care;FDA GLPs;GLP Toxicology Study;Facility SOPs;Dose Formulation;Disqualification Proceeding
Introduction
1. Subpart A - General Provisions
i) Sec. 58.1 Scope
ii) Sec. 58.3 Definitions.
iii) Sec. 58.10 Applicability to studies performed under grants and contracts.
iv) Sec. 58.15 Inspection of a testing facility.
2. Subpart B - Organization and Personnel
i) Sec. 58.29 Personnel.
ii) Sec. 58.31 Testing facility management.
iii) Sec. 58.33 Study director
iv) Sec. 58.35 Quality assurance unit.
3. Subpart C - Facilities
i) Sec. 58.41 General.
ii) Sec. 58.43 Animal care facilities.
iii) Sec. 58.45 Animal supply facilities.
iv) Sec. 58.47 Facilities for handling test and control articles.
v) Sec. 58.49 Laboratory operation areas
vi) Sec. 58.51 Specimen and data storage facilities
4. Subpart D - Equipment
i) Sec. 58.61 Equipment design.
ii) Sec. 58.63 Maintenance and calibration of equipment.
5. Subpart E - Testing Facilities Operation
i) Sec. 58.81 Standard operating procedures.
ii) Sec. 58.83 Reagents and solutions.
iii) Sec. 58.90 Animal care.
6. Subpart F - Test and Control Articles
i) Sec. 58.107 Test and control article handling.
ii) Sec. 58.113 Mixtures of articles with carriers.
7. Subpart G - Protocol for and Conduct of a Nonclinical Laboratory Study
i) Sec. 58.120 Protocol.
ii) Sec. 58.130 Conduct of a nonclinical laboratory study.
8. Subpart J - Records and Reports
i) Sec. 58.185 Reporting of nonclinical laboratory study results.
ii) Sec. 58.190 Storage and retrieval of records and data.
9. Subpart K - Disqualification of Testing Facilities i) Sec. 58.200 Purpose.
ii) Sec. 58.202 Grounds for disqualification.
iii) Sec. 58.204 Notice of and opportunity for hearing on proposed disqualification.
iv) Sec. 58.210 Actions upon disqualification.
v) Sec. 58.213 Public disclosure of information regarding disqualification.
vi) Sec. 58.217 Suspension or termination of a testing facility by a sponsor.
vii) Sec. 58.219 Reinstatement of a disqualified testing facility.
10. Data Integrity: Paper and Electronic 21CFR11
1. Subpart A - General Provisions
i) Sec. 58.1 Scope
ii) Sec. 58.3 Definitions.
iii) Sec. 58.10 Applicability to studies performed under grants and contracts.
iv) Sec. 58.15 Inspection of a testing facility.
2. Subpart B - Organization and Personnel
i) Sec. 58.29 Personnel.
ii) Sec. 58.31 Testing facility management.
iii) Sec. 58.33 Study director
iv) Sec. 58.35 Quality assurance unit.
3. Subpart C - Facilities
i) Sec. 58.41 General.
ii) Sec. 58.43 Animal care facilities.
iii) Sec. 58.45 Animal supply facilities.
iv) Sec. 58.47 Facilities for handling test and control articles.
v) Sec. 58.49 Laboratory operation areas
vi) Sec. 58.51 Specimen and data storage facilities
4. Subpart D - Equipment
i) Sec. 58.61 Equipment design.
ii) Sec. 58.63 Maintenance and calibration of equipment.
5. Subpart E - Testing Facilities Operation
i) Sec. 58.81 Standard operating procedures.
ii) Sec. 58.83 Reagents and solutions.
iii) Sec. 58.90 Animal care.
6. Subpart F - Test and Control Articles
i) Sec. 58.107 Test and control article handling.
ii) Sec. 58.113 Mixtures of articles with carriers.
7. Subpart G - Protocol for and Conduct of a Nonclinical Laboratory Study
i) Sec. 58.120 Protocol.
ii) Sec. 58.130 Conduct of a nonclinical laboratory study.
8. Subpart J - Records and Reports
i) Sec. 58.185 Reporting of nonclinical laboratory study results.
ii) Sec. 58.190 Storage and retrieval of records and data.
9. Subpart K - Disqualification of Testing Facilities i) Sec. 58.200 Purpose.
ii) Sec. 58.202 Grounds for disqualification.
iii) Sec. 58.204 Notice of and opportunity for hearing on proposed disqualification.
iv) Sec. 58.210 Actions upon disqualification.
v) Sec. 58.213 Public disclosure of information regarding disqualification.
vi) Sec. 58.217 Suspension or termination of a testing facility by a sponsor.
vii) Sec. 58.219 Reinstatement of a disqualified testing facility.
10. Data Integrity: Paper and Electronic 21CFR11
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
FDA inspections;GLP facilities;FDA code of federal regulations;21 CFR Part 58;Nonclinical Laboratory Studies;Test Article;Control Article;GLP Regulation;Nonclinical Study;GLP Study;Sop Deviation;CFR;QAU;Nonclinical Safety Studies;GLP Compliance;GLP Requirement;Marketing Permit;OECD GLP;Testing Facility Management;Animal Studies;Public Health Service Act;Multisite Studies;Study Director;Animal Care;FDA GLPs;GLP Toxicology Study;Facility SOPs;Dose Formulation;Disqualification Proceeding
