GLP Quality Audit Manual

Milton A. Anderson (Autor)

Buch | Softcover

464 Seiten

2020 | 3rd edition
CRC Press (Verlag)
978-0-367-39843-9 (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.

Erscheinungsdatum	02.09.2019
Verlagsort	London
Sprache	englisch
Maße	219 x 276 mm
Gewicht	2000 g
Themenwelt	Medizin / Pharmazie ► Allgemeines / Lexika
	Naturwissenschaften ► Biologie
	Technik
ISBN-10	0-367-39843-5 / 0367398435
ISBN-13	978-0-367-39843-9 / 9780367398439
Zustand	Neuware