Format:
1 Online-Ressource (207 Seiten)
ISBN:
9781000789591
Series Statement:
Drugs and the Pharmaceutical Sciences Ser
Content:
This all-encompassing volume addresses every critical aspect of Good Laboratory Practice (GLP) regulations and demonstrates effective strategies for implementation in a variety of laboratory settings
Note:
Description based on publisher supplied metadata and other sources
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Cover -- Half Title -- Series Information -- Title Page -- Copyright Page -- Table of Contents -- Acknowledgments -- Editor Biography -- Contributors -- Introduction -- Title 21 - Food And Drugs: Chapter I - Food And Drug Administration -- Chapter One 21 CFR 58 Subpart A - General Provisions -- Sec. 58.1 Scope -- Sec. 58.3 Definitions -- Sec. 58.10 Applicability to Studies Performed Under Grants and Contracts -- Sec. 58.15 Inspection of a Testing Facility -- References -- Chapter Two 21 CFR 58 Subpart B - Organization and Personnel -- Introduction and Overview -- Section 58.29: Personnel -- Training and Education Requirements -- Training and Experience -- Number of Personnel -- Health Precautions -- Clothing Requirements -- Illnesses -- Section 58.31: Testing Facility Management -- Study Director Designation -- Study Director Replacement -- Quality Assurance Unit Presence -- Test and Control Articles Characterization -- Adequate Resources -- Appropriate Training -- Compliance With GLP Regulations -- Section 58.33: Study Director -- Protocol and Amendments Approval -- Data Recording -- Deviation Documentation -- Test System Confirmation -- GLP Compliance -- Archival of Study-Related Materials -- Section 58.35: Quality Assurance Unit -- QAU Responsibilities -- Monitoring Activities -- Master Schedule -- Copies of Protocols -- Inspections -- Reporting of Inspections -- Deviations Documentation -- Report Audit -- Compliance Statement -- Documentation Practices -- Inspections -- Chapter Three 21 CFR 58 Subpart C - Facilities -- Introduction -- Sec. 58.41 General Text From the GLPs -- Application, Implications, and Key Considerations -- Proposed FDA GLP Amendment -- Sec. 58.43 Animal Care Facilities Text From the GLPs -- Application, Implications, and Key Considerations -- Proposed FDA GLP Amendment
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Sec. 58.45 Animal Supply Facilities Text From the GLPs -- Application, Implications, and Key Considerations -- Sec. 58.47 Facilities for Handling Test and Control Articles Text From the GLPs -- Application, Implications, and Key Considerations -- Proposed FDA GLP Amendment -- Sec. 58.49 Laboratory Operation Areas Text From the GLPs -- Application, Implications, and Key Considerations -- Sec. 58.51 Specimen and Data Storage Facilities Text From the GLPs -- Application, Implications, and Key Considerations -- Summary -- References -- Chapter Four 21 CFR 58 Subpart D - Equipment -- Sec. 58.61 Equipment Design -- Design and Capacity: Equipment (Generation, Measurement, Or Assessment of Data) -- Design and Capacity: Equipment (Facility Environmental Control) -- Suitable Location (Operation, Inspection, Cleaning, and Maintenance) -- Sec. 58.63 Maintenance and Calibration of Equipment -- Sec. 58.63 (A) -- Inspection -- Cleaning -- Calibration -- Maintenance -- Business Continuity -- Standardization Testing -- Sec. 58.63 (B) -- Sec. 58.63 (C) -- Chapter Five 21 CFR 58 Subpart E -Testing facilities operation -- Introduction -- Sec. 58.81 Standard Operating Procedures -- Text From the GLPs -- Application, Implications, and Key Considerations -- SOPs Required Under the FDA GLPs -- Proposed FDA GLP Amendment -- Sec. 58.83 Reagents and Solutions -- Text From the GLPs -- Application, Implications, and Key Considerations -- Sec. 58.90 Animal Care -- Text From the GLPs -- Application, Implications, and Key Considerations -- Proposed FDA GLP Amendment -- References -- Chapter Six 21 CFR 58 Subpart F - Test and Control Articles -- Introduction and Overview -- Section 58.105: Test and Control Articles Characterization -- Characteristics -- Identity and Strength -- Purity -- Composition -- Methods of Synthesis, Fabrication, Or Derivation
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GMP- Versus GLP-Grade Material -- Use of Marketed/commercial Products -- Stability -- Labelling -- Archived Samples -- Section 58.107: Test and Control Articles Handling -- Storage -- Distribution -- Identification -- Chain of Custody -- Section 58.113: Mixtures of Articles With Carriers -- Analyses -- Concentration and Uniformity -- Stability -- Reserved -- Expiration Dates -- Chapter Seven 21 CFR 58 Subpart G - Protocol for and Conduct of a Nonclinical Laboratory Study -- Introduction -- Regulatory Requirements of a Protocol (58.120) -- Best Practices/examples -- (B) All Changes in Or Revisions of an Approved Protocol and the Reasons Therefore Shall Be Documented, Signed By the Study Director, Dated, and Maintained With the Protocol. -- Regulatory Requirements for the Conduct of a Nonclinical Laboratory Study (58.130) -- (C) Specimens Shall Be Identified By Test System, Study, Nature, and Date of Collection. This Information Shall Be Located On the Specimen Container Or Shall Accompany the Specimen in a Manner That Precludes Error in the Recording and Storage of Data. -- (D) Records of Gross Findings for a Specimen From Postmortem Observations Should Be Available to a Pathologist When Examining That Specimen Histopathologically. -- (E) All Data Generated During the Conduct of a Nonclinical Laboratory Study, Except Those That Are Generated By Automated Data Collection Systems, Shall Be Recorded Directly, Promptly, and Legibly in Ink. All Data Entries Shall Be Dated On the Date of En -- References -- Chapter Eight 21 CFR 58 Subpart J - Records and Reports -- Records and Reports1 -- 58.185 Reporting of Nonclinical Laboratory Study Results -- 58.190 Storage and Retrieval of Records and Data -- References -- Chapter Nine 21 CFR 58 Subpart K - Disqualification of Testing Facilities -- Sec. 58.200 Purpose -- Sec. 58.202 Grounds for Disqualification
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Sec. 58.204 Notice of and Opportunity for Hearing On Proposed Disqualification -- Sec. 58.206 Final Order On Disqualification -- Sec. 58.210 Actions Upon Disqualification -- Sec. 58.213 Public Disclosure of Information Regarding Disqualification -- Sec. 58.215 Alternative Or Additional Actions to Disqualification -- Sec. 58.217 Suspension Or Termination of a Testing Facility By a Sponsor -- Sec. 58.219 Reinstatement of a Disqualified Testing Facility -- Examples of Observations From FDA Citations -- References -- Chapter Ten Data Integrity: Paper and Electronic 21CFR11 -- References -- Index
Additional Edition:
Erscheint auch als Druck-Ausgabe Bunn, Graham P. Good Laboratory Practice for Nonclinical Studies Milton : Taylor & Francis Group,c2022 ISBN 9780367336271
Language:
English
Subjects:
Chemistry/Pharmacy
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Biology
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