2.1 These guidelines focus mainly on the overall concept of validation and are intended as a basic guide for use by GMP inspectors and manufacturers. It is not the intention to be prescriptive in specific validation requirements.

This document serves as general guidance only, and the principles may be considered useful in its application in the manufacture and control of active pharmaceutical ingredients (APIs) and finished pharmaceutical products. Validation of specific processes and products, for example in sterile product manufacture, requires much more consideration and a detailed approach that is beyond the scope of this document.

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.