GLP Quality Audit Manual
Book Details
Format
Paperback / Softback
ISBN-10
0367398435
ISBN-13
9780367398439
Publisher
Taylor & Francis Ltd
Imprint
CRC Press
Country of Manufacture
GB
Country of Publication
GB
Publication Date
May 27th, 2020
Print length
464 Pages
Weight
1,232 grams
Dimensions
21.90 x 27.60 x 3.50 cms
Product Classification:
Pharmaceutical technology
Ksh 12,750.00
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Designed to enable readers to plan and execute their own audits, this comprehensive guide presents discussions of and practical applications related to establishing a GLP QA unit and performing effective GLP audits. The first section provides the foundation of information needed for designing and initiating a Good Laboratory Practice quality assurance program. Section II contains ready-to-use audit checklists and regulatory references that are in accordance with the most recent regulations. Section Ill comprises the full texts of the relevant standards and regulations along with the Priniciples of Good Laboratory Practice.
Designed to enable readers to plan and execute their own audits, this comprehensive guide presents both discussions and practical applications related to establishing a GLP QA unit and performing effective GLP audits. The first section provides the foundation of information needed for designing and initiating a Good Laboratory Practice quality assurance program. Section II contains ready-to-use audit checklists and regulatory references that are in accordance with the most recent regulations. Section III illustrates with examples the document requirements of the Quality Assurance Unit and provides a clear understanding of its function. Section IV comprises the full texts of the relevant standards and regulations along with the Principles of Good Laboratory Practice.
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