Cleaning Validation - Gil Bismuth, Shosh Neumann

Cleaning Validation

A Practical Approach
Buch | Softcover
200 Seiten
2019
CRC Press (Verlag)
978-0-367-39892-7 (ISBN)
77,30 inkl. MwSt
Offering a detailed, step-by-step guide to building a compliant cleaning validation program, Cleaning Validation: A Practical Approach covers trends in control, procedures, cleaning agents and tools, sampling techniques, analytical methods, and regulatory issues. The author provides practical examples, database formats, standard operating procedures, work instructions, protocols, and reports. He gives readers the tools they need to develop an effective and manageable program that will not only be acceptable to both US and non-US regulatory authorities but will conserve an organization's time, money, and people resources.

Bismuth, Gil; Neumann, Shosh

DEVELOPING A CLEANING PROCEDURE . Contamination Control. Regulatory Requirements. Cleaning Basic Concepts. Cleaning Procedure. DEVELOPING A CLEANING VALIDATION PROGRAM. Cleaning Validation Policy. Contamination Acceptance Limits. Cleaning Validation Planning & Execution. Cleaning Validation Monitoring & Maintenance. Special Cleaning Validation Issues. Cleaning Validation Trends. Appendices: Cleaning & Cleaning Validation Procedures. Cleaning. Cleaning Validation.

Erscheinungsdatum
Verlagsort London
Sprache englisch
Maße 178 x 254 mm
Gewicht 367 g
Themenwelt Medizin / Pharmazie Medizinische Fachgebiete Laboratoriumsmedizin
Naturwissenschaften Biologie
Technik
ISBN-10 0-367-39892-3 / 0367398923
ISBN-13 978-0-367-39892-7 / 9780367398927
Zustand Neuware
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