Cleaning Validation

A Practical Approach
1. Auflage 2000
ISBN: 978-1-57491-108-4
Verlag: CRC Press

Buch, Englisch, 200 Seiten, Format (B × H): 183 mm x 260 mm, Gewicht: 581 g

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.

Zielgruppe

Academic

Autoren/Hrsg.

Bismuth, Gil

Neumann, Shosh

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Pharmazie
• Wirtschaftswissenschaften Betriebswirtschaft Management

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.

Über Autor(innen)

Bismuth, Gil; Neumann, Shosh