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

Introduction

Validation is an essential part of GMP, and an element of QA
Basic principles include:

- Safety, quality and efficacy of products

- Built into the product - as it cannot be "inspected or tested into a product"

- Critical steps in the process need to be validated
Need for confidence that the product will consistently meet predetermined specifications and attributes

1. Introduction

Validation is an essential part of good manufacturing practices (GMP). It is, therefore, an element of the quality assurance programme associated with a particular product or process. The basic principles of quality assurance have as their goal the production of products that are fit for their intended use.

These principles are as follows:

Quality, safety and efficacy must be designed and built into the product.
Quality cannot be inspected or tested into the product.
Each critical step of the manufacturing process must be validated.

Other steps in the process must be under control to maximize the probability that the finished product consistently and predictably meets all quality and design specifications.

Validation of processes and systems is fundamental to achieving these goals.

It is by design and validation that a manufacturer can establish confidence that the manufactured products will consistently meet their product specifications.