Good Laboratory Practice for Nonclinical Studies [Paperback]

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

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. 58.45lCe