How to Validate a Pharmaceutical Process: Part of the Expertise in Pharmaceutical Process Technology Series

How to Validate a Pharmaceutical Process, part of the Expertise in Pharmaceutical Process Technology series, provides a how to? approach to developing and implementing a sustainable pharmaceutical process validation program. This latest entry in the series addresses practical problems and offers solutions to qualify and validate a pharmaceutical process. It contains numerous case studies throughout and covers important topics such as the lifecycle approach, quality by design, risk assessment, critical process parameters, US and international regulatory guidelines, and more. This book illustrates the methods and reasoning behind processes and protocols. Understanding the why? is critical to a successful and defensible process validation, making this book an essential research companion for all practitioners engaged in pharmaceutical process validation. Thoroughly referenced and based on the latest research and literatureAddresses practical problems and offers solutions to qualify and validate a pharmaceutical processIllustrates the most common issues related to developing and implementing a sustainable process validation program and provides valuable examples on how to be successfulContains numerous case studies throughout and covers important topics such as the lifecycle approach, quality by design, risk assessment, critical process parameters, US and international regulatory guidelines, and more INDICE: Preface Introduction New & Legacy Products The three phases of PV What it will attempt to do Product Status Section I - What is Process Validation and Why do Process Validation? Defining Process Validation Risk Based Approach Good Science Brief Review of the Regulations and Guidelines 21CFR ICH Other regulatory information The Role of Change Control Section II - Stage I - Process Development Starting the Process Validation Program Validation Master Plan SOPs Quality Programs Equipment and Utility Qualification Determining what needs to be done Direct Indirect System Boundaries Commissioning Qualification IQ OQ PQ Dealing with Computers and Automation Validation General Computer System Validation Part 11 Process Development Risk Assessment Process Description (Defining the process) Critical v. Non-Critical Determining CPPs and CQAs What variables are in the process Why are they variable? Can they be controlled? Section II - Process Qualification The Process Validation Protocol What makes a good protocol Sampling Plans for Process Validation Conducting the Process Validation protocol Solid Dose Creams, Liquids and Ointments Parenterals Preparing theProcess Validation report Dealing with Deviations Investigations Resolution Section III - Continued Process Verification Collecting and Evaluating Production Use of Control Charts Use of Statistical Process Control - pPk, Pk, cPk, cP Section IV - Other Related Activities Cleaning- Verification to Validation Facility Qualification

• ISBN: 978-0-12-804148-2
• Editorial: Academic Press
• Encuadernacion: Rústica
• Páginas: 112
• Fecha Publicación: 01/06/2016
• Nº Volúmenes: 1
• Idioma: Inglés