Cleaning Validation

A Practical Approach

Gil Bismuth, Shosh Neumann (Autoren)

Buch | Hardcover

200 Seiten

2000
Crc Press Inc (Verlag)
978-1-57491-108-4 (ISBN)

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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.

Erscheint lt. Verlag	31.1.2000
Verlagsort	Bosa Roca
Sprache	englisch
Maße	178 x 254 mm
Gewicht	530 g
Themenwelt	Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
	Medizin / Pharmazie ► Pflege
	Naturwissenschaften ► Biologie
	Technik
	Wirtschaft ► Betriebswirtschaft / Management ► Unternehmensführung / Management
ISBN-10	1-57491-108-2 / 1574911082
ISBN-13	978-1-57491-108-4 / 9781574911084
Zustand	Neuware