Full Description
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
Contents
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
