Pharmaceutical Validation Tool For Quality Management

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Pharmaceutical Validation tool for Quality Management
Abstract
Pharmaceutical validations is part of CGMP regulations by which one can build quality attributes of pharmaceutical specification, i.e. safety, efficacy, purity, in pharmaceutical products. It assures that the process follow for the manufacturing of pharmaceutical products is well controlled and monitored at its critical parameters for consistently producing the quality products.
The present review describes the importance of validation in pharmaceutical industry, its requirement for approval of new drug application by the various regulatory agencies. Furthermore it highlights the current guidance on process validation by USFDA, EMA.
Key Words: Validation, Quality assurance, critical parameters, NDA, USFDA, EMA, Validation Guidelines

Contents
Introduction 2
History of Pharmaceutical validation 2
Approaches to Process Validation 4
Stages of process validation according to life cycle approach 4
Stage I: Process Design 4
Stage II: Process Qualification 4
Stage III: Continued Process Verification 5
Features of USFDA Process validation guidance 2011 5
Conclusion 6
References 6

Introduction
Quality is concept applicable at everywhere from business to have successful life. Everyone wants to buy the quality products and want to live the quality life as per the standards determined by them for it. As concern with pharmaceutical industries, they are built for to bring the quality in health of human and animal beings.
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