Gil Bismuth: Cleaning Validation

Cover: 9780367398927 | Cleaning Validation | A Practical Approach | Gil Bismuth (u. a.)

Rückseite: 9780367398927 | Cleaning Validation | A Practical Approach | Gil Bismuth (u. a.)

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Sprache: Englisch

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Beschreibung

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.

Über den Autor

Bismuth, Gil; Neumann, Shosh

Inhaltsverzeichnis

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.

Details

Erscheinungsjahr:	2019
Fachbereich:	Andere Fachgebiete
Genre:	Importe , Medizin
Rubrik:	Wissenschaften
Medium:	Taschenbuch
ISBN-13:	9780367398927
ISBN-10:	0367398923
Sprache:	Englisch
Einband:	Kartoniert / Broschiert
Autor:	Bismuth, Gil Neumann, Shosh
Hersteller:	CRC Press
Verantwortliche Person für die EU:	Libri GmbH, Europaallee 1, D-36244 Bad Hersfeld, gpsr@libri.de
Maße:	254 x 178 x 11 mm
Von/Mit:	Gil Bismuth (u. a.)
Erscheinungsdatum:	05.09.2019
Gewicht:	0,387 kg