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Pharmaceutical Regulatory Affairs by Jigar Vyas, Nensi Raytthatha, Isha Shah is a nonfiction available to read on EtoBox.

What is Pharmaceutical Regulatory Affairs about?

Front Cover Half Title Page Title Page Copyright Foreword Preface Contents 1. Pilot Plant and Scale-up Techniques 1.1 Introduction 1.1.1 Scale-Up Process 1.1.2 Significance 1.1.3 Steps Involved in the Scale-up Process 1.1.4 Pilot Plant Layout Design 1.1.5 General Considerations of Pilot Plant 1.1.6 GMP Consideration 1.1.7 Product Consideration 1.2 Scale-up and Post-approval Changes 1.2.1 Introduction 1.2.2 Scientific and Regulatory Rational for SUPAC 1.2.3 Purpose of Guideline 1.2.4 SUPAC Guideline 1.2.5 SUPAC Limitations 1.3 Postmarketing Surveillance (PMS) 1.3.1 Benefits of PMS System 1.3.2 Importance of PMS 1.3.3 PMS Sources of Information 1.3.4 PMS Procedure 1.3.5 Methods of Surveillance 1.4 Platform Technology 1.4.1 Introduction 1.4.2 Key Benefits of a Well-established Platform Technology 1.4.3 Designing of Platform Technology 1.4.4 Application of Platform Technology 2. Technology Transfer 2.1 Technology Transfer Protocol 2.1.1 Reason for Technology Process/Transfer 2.1.2 Transfer Process 2.1.3 Significance of Technology Transfer 2.2 Quality Risk Management (QRM) 2.2.1 QRM Principles 2.2.2 Process of QRM 2.3 Transfer from R and D to Production 2.3.1 Process Information 2.3.2 P

Who reads Pharmaceutical Regulatory Affairs?

Author

Jigar Vyas, Nensi Raytthatha, Isha Shah

Publisher

Satish Kumar Jain

Published

2023

Language

EN

ISBN

9789354669958

Category

nonfiction