Abstract

Validation practice in the pharmaceutical industry is indispensable for quality assurance and quality control. It confirms that the facility, process, operating system, analytical method, or product meets its intended use. Therefore, it assures the quality of pharmaceutical manufacture and the justification of analytical results. This article first presents the definition of validation in pharmaceutical industry, and then summarizes good validation practice on two basic ranges, process validation and analytical method validation, from regulated requirement, quality-by-design concept, and technology transfer perspectives. The statistical justification of pharmaceutical validation plays an important role for its valid and fair assessment.