Glp Quality Audit Manual

ISBN-13: 9780367398439 / Angielski / Miękka / 2020 / 464 str.

Milton A. Anderson

Opis

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.

Spis treści

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.

O autorze

Anderson, Milton A.