FDA good laboratory practice requirements / edited by Graham P. Bunn.
| Other author | Bunn, Graham P. |
| Format | Electronic |
| Edition | First edition. |
| Publication Info | Boca Raton : CRC Press, 2023. |
| Description | pages cm |
| Supplemental Content | Full text available from eBooks on EBSCOhost |
| Supplemental Content | Full text available from Taylor & Francis eBooks |
| Subjects |
| Variant title | Food and Drug Administration good laboratory practice requirements |
| Variant title | Good laboratory practice requirements |
| Series | Drugs and the pharmaceutical sciences Drugs and the pharmaceutical sciences. ^A800938 |
| Contents | Subpart A - General Provisions -- Subpart B - Organization and Personnel -- Subpart C - Facilities -- Subpart D - Equipment -- Subpart E - Testing Facilities Operation -- Subpart F - Test and Control Articles -- Subpart G - Protocol for and Conduct of a Nonclinical Laboratory Study -- Subpart J - Records and Reports -- Subpart K - Disqualification of Testing Facilities -- Data Integrity: Paper and Electronic 21CFR. |
| Abstract | "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"-- Provided by publisher. |
| Bibliography note | Includes bibliographical references and index. |
| Access restriction | Available only to authorized users. |
| Technical details | Mode of access: World Wide Web |
| Genre/form | Electronic books. |
| LCCN | 2022026130 |
| ISBN | 9780367336271 (hardback) |
| ISBN | 9781032381152 (paperback) |
| ISBN | (ebook) |