GLP Quality Audit Manual

Milton A. Anderson (Autor)

Buch | Hardcover

462 Seiten

2000 | 3rd edition
Crc Press Inc (Verlag)
978-1-57491-106-0 (ISBN)

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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.

Anderson, Milton A.

SECTION I: GOOD LABORATORY PRACTICES: Development of Regulations & Guidelines. The QA Unit. Quality Inspections & Audits. Contract Audits. System Audits. Internet Resources. Understanding GLP. SECTION II: QA CHECKLISTS: GLP Audit Checklist, Complete. Abbreviated GLP Audit Checklists. SECTION III: DOCUMENT/REPORT EXAMPLES: Quality Assurance Documents. Inspection Report Examples. SECTION IV: REFERENCES/REGULATORY TEXTS.

Erscheint lt. Verlag	22.6.2000
Verlagsort	Bosa Roca
Sprache	englisch
Maße	210 x 280 mm
Gewicht	970 g
Themenwelt	Naturwissenschaften ► Biologie
ISBN-10	1-57491-106-6 / 1574911066
ISBN-13	978-1-57491-106-0 / 9781574911060
Zustand	Neuware