The GLP regulations have been enacted since 1978 and are currently under a proposed FDA amendment to revise terminology and accommodate other changes relating to advances in technology related to the industry. This book provides a unique opportunity to access interpretation of the 21CFR58 regulatory requirements from leading industry experts with a vast knowledge and expertise in their fields. The approach used takes the regulations, provides interpretations and references to examples and regulatory actions. Data integrity and the use of electronic systems in compliance with 21CFR11 Electronic Records: Electronic Signatures are also discussed.
• Unique volume covering FDA inspections of GLP facilities
• Provides a detailed interpretation of GLP Regulations
• Presents the latest on electronic data management in GLP
• Describes GLP and computer systems validation
• Can be referenced repeatedly in supporting daily hands on implementation of the CFR requirements
Author(s): Graham P. Bunn
Series: Drugs and the Pharmaceutical Sciences
Publisher: CRC Press
Year: 2022
Language: English
Pages: 206
City: Boca Raton
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
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
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
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
