INTRODUCTION AND GENERAL OVERVIEW OF PHARMACEUTICAL PROCESS VALIDATION: A REVIEW

Abstract

Drugs are critical elements in health care. They must be manufactured to the highest quality levels. End-product testing by itself does not guarantee the quality of the product. Quality assurance techniques must be used. In the pharmaceutical industry, process validation performs this task, ensuring that the process does what it purports to do. Validation is defined as the collection and evaluation of data, from the process design stages through commercial production, which establishes scientific evidences that a process is capable of consistently delivering quality product. It is also a regulatory requirement. Total Quality Management and specifications according to regulatory guidelines involved in the pharmaceutical production has a great impact significantly on the quality of products. The validation protocol includes inventory control and equipment inspections in the preliminary steps and in-process controls in the subsequent steps. Process controls are mandatory in good manufacturing practices (GMP).This review critically evaluates the need of pharmaceutical validation, the various approaches and steps involved, and other pertinent considerations.