Good Clinical, Laboratory and Manufacturing Practices

Good Clinical, Laboratory and Manufacturing Practices
Author: Philip Carson
Publisher: Royal Society of Chemistry
Total Pages: 657
Release: 2007-10-31
Genre: Science
ISBN: 1847557724

Quality assurance and good laboratory practices are becoming essential knowledge for professionals in all sorts of industries. This includes internal and external audit procedures for compliance with the requirements of good clinical, laboratory and manufacturing practices. Spanning chemical, cosmetic and manufacturing industries, Good Clinical, Laboratory and Manufacturing Practices: Techniques for the QA professional is aimed at: chemists, clinicians, ecotoxicologists, operation managers, pharmaceutical process managers, quality assurance officers, technicians and toxicologists. In addition sections on harmonisation of quality systems will be of value to safety, health and environment advisors. This comprehensive and high level reference will be an indispensable guide to research laboratories in academia and industry. Additional training material is also included.

Good Clinical, Laboratory and Manufacturing Practices

Good Clinical, Laboratory and Manufacturing Practices
Author: Phillip A. Carson
Publisher: Royal Society of Chemistry
Total Pages: 657
Release: 2007
Genre: Science
ISBN: 0854048340

Provides practical advice for the quality assurance professional responsible for monitoring compliance with legal requirements and accepted standards of preclinical safety studies, clinical trials and manufacture of drugs. This book also offers a framework for integrating these standards with other quality management systems.

Good Laboratory Practice for Nonclinical Studies

Good Laboratory Practice for Nonclinical Studies
Author: Graham P. Bunn
Publisher: CRC Press
Total Pages: 179
Release: 2022-12-13
Genre: Medical
ISBN: 1000789594

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

Good Laboratory Practice Regulations

Good Laboratory Practice Regulations
Author: Sandy Weinberg
Publisher: CRC Press
Total Pages: 306
Release: 2007-01-19
Genre: Medical
ISBN: 0849375843

Recent changes in the interpretation and enforcement of 21 CFR Part 11 have shifted the focus of Good Laboratory Practice (GLP) regulations to concentrate on the acceptance of electronic signatures, the archiving of data, the security of electronic documents, and the automation of laboratory procedures. This all-encompassing Fourth Edition addresse

Good Laboratory and Clinical Practices

Good Laboratory and Clinical Practices
Author: Phillip A. Carson
Publisher: Butterworth-Heinemann
Total Pages: 424
Release: 1990
Genre: Medical
ISBN:

This book provides practical and detailed advice for the quality assurance professional who is responsible for monitoring compliance with legal requirements and accepted standards and guidelines. This manual is useful for those subject to inspection and audit, such as toxicologists, ecotoxicologists, technicians, analysts, chemists, clinicians, and process managers.

Good Clinical Practices in Pharmaceuticals

Good Clinical Practices in Pharmaceuticals
Author: Graham P. Bunn
Publisher:
Total Pages: 0
Release: 2024-12-02
Genre: Medical
ISBN: 9781032524078

This book provides a thorough reference on Good Clinical Practice (GCP) which is the international ethical, scientific and practical standard to which all clinical research is conducted.