WHO Supplementary Training Modules: Validation, Water, Air Handling Systems - Validation (Part 3): Cleaning Validation: Validation

WHO Supplementary Training Modules: Validation, Water, Air Handling Systems - Validation (Part 3): Cleaning Validation
(2006; 43 pages)

Table of Contents

Validation

Scope

Guidelines: General aspects of cleaning validation
Excluding specialized cleaning or inactivation

- e.g. for removal of viral or mycoplasmal contaminants in the biological manufacturing industry.
Normally cleaning validation needed for critical cleaning, e.g.

- between manufacturing of one product and another

- contact surfaces (products, drug products and API).

2. Scope

2.1 These guidelines describe the general aspects of cleaning validation, excluding specialized cleaning or inactivation that may be required, e.g. for removal of viral or mycoplasmal contaminants in the biological manufacturing industry.

2.2 Normally cleaning validation would be applicable for critical cleaning such as cleaning between manufacturing of one product and another, of surfaces that come into contact with products, drug products and API.