WHO Supplementary Training Modules: Validation, Water, Air Handling Systems - Validation (Part 1): General Overview: Validation

WHO Supplementary Training Modules: Validation, Water, Air Handling Systems - Validation (Part 1): General Overview
(2006; 39 pages)

Table of Contents

Validation

Scope

Many factors affecting the different types of validation
Manufacturers should plan validation to ensure

- regulatory compliance and

- product quality, safety and consistency
The general text in the guideline (part 1 of presentation) may be applied to validation and qualification of:

- premises, equipment, utilities and systems

- processes and procedures
More specific principles addressed in the appendices (parts 2 to 7)
Semi-automatic or fully automatic clean-in-place (CIP) systems and other special cases should be treated separately.

2.2 There are many factors affecting the different types of validation and it is, therefore, not intended to define and address all aspects related to one particular type of validation here.

2.3 Manufacturers should plan validation in a manner that will ensure regulatory compliance and ensuring that product quality, safety and consistency are not compromised.

2.4 The general text in the main part of these guidelines may be applicable to validation and qualification of premises, equipment, utilities and systems, and processes and procedures. More specific principles of qualification and validation are addressed in the appendices. Semi-automatic or fully automatic clean-in-place (CIP) systems and other special cases should be treated separately.