Process Validation of Pharmaceutical Dosages Form: A Review

Goyal Anju and Priyambada Pandey*

Received: October 14, 2017;   Published: October 25, 2017

DOI: 10.26717/BJSTR.2017.01.000463

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Abstract

Quality is always an imperative prerequisite when consider any product. Therefore, drugs must be manufactured to the highest quality levels. Validation is a part of the quality assurance program and is fundamental to an efficient production operation for building quality into the products. Validation of the individual steps of the processes is called the process validation. Process validation involves the collection and evaluation of data, from the process design stage throughout production, that establish scientific evidence that a process is capable of consistently delivering a quality drug substance. The goal of the validation is to ensure that quality is built into the system at every step, and not just tested for at the end. It involves the collection and evaluation of data, from the process design stage throughout production, that establish scientific evidence that a process is capable of consistently delivering a quality drug substance. Process validation is an integral part of Quality Assurance as per cGMP. Validation and quality assurance will go hand in hand, ensuring the thorough quality for the products. Hence, an emphasis made on to review that gives a detailed, overview of validation. According to GMP, validation studies are required to be done as per predefined protocols. Different dosage forms have different validation protocols. The purpose of this work is to present an introduction and general overview on process validation of pharmaceutical manufacturing process with special reference to the requirements stipulated by the US Food and Drug Administration (FDA) of Solids (tablets and capsules), liquids and semisolids.

Keywords: Quality; Validation; Dosages form; CGMP

Abstract| Introduction| Process Validation| Industrial Process Evaluation and Selection for Dosages form| Process Validation Of Liquids [19,20]| Critical Parameters to be Validated| Unit Operation For Semisolid System| Conclusion| References|