Abstract

INDUSTRIAL PROCESS VALIDATION IN SOLID DOSAGE FORM: A REVIEW

Monali Wawre* Babita Dodke, Agrasen Moon and Gajanan Javalkar

ABSTRACT

The present article gives an introduction and general overview on process validation of pharmaceutical manufacturing process especially tablet manufacturing process. The concept of validation was first proposed by Food and Drug Administration officials in 1970 in order to improve the quality of pharmaceuticals. The principal objective of dosage form design is to achieve a predictable therapeutic response to a drug included in a formulation which is capable of large scale manufacture with reproducible product quality. Solid dosage forms include tablets and capsules. Quality is always an imperative prerequisite when we consider any product. Therefore, drugs must be manufactured to the highest quality levels. Process Validation is one of the important steps in achieving and maintaining the quality of final product. Process validation is an essential component for the safety of drug product and also to maintain the quality of the product. Process validation is the fundamental component for assuring the quality system used by pharmaceutical industries. Process validation is the key element to assure the identity, purity, safety, efficacy and also maintaining the quality of final product. The Process validation precisely focused on the aim, method of analysis, and knowledge. The Process validation precisely focused on the aim, method of analysis, and knowledge. The Process validation establishes the flexibilities and limitations which are faced during the manufacturing process; the variables are controlled for attaining the desired attributes, which assures a consistency in quality of product throughout the product life.

Keywords: Process validation, good manufacturing practices (GMP), Approaches to Validation.