How to validate a pharmaceutical process

by Ostrove, Steve

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Title Statements

Full title :How to validate a pharmaceutical process / Steven A. Ostrove.

Edition Statements

Publication Date:2016.

Publication Statements

Publisher(s):Academic Press is an imprint of Elsevier
Place of Publication:London, UK
Language:eng
Publication Date:2016.

Notes

Incluye índices.

Descripción basada en el recurso electrónico; tít. tomado del PDF (ScienceDirect, visitado en Junioe 21, 2016).

The Physical Object

Description:1 online resource.

Edition Identifiers

ISBN:9780128096536, 0128096535, 012804148X, 9780128041482
oclc:ocn984824596
Dewey Decimal:338.4/76151

Front Cover; How to Validate a Pharmaceutical Process; Copyright Page; Dedication; Contents; Author Biography; Preface; Acknowledgment; About the Expertise in the Pharmaceutical Process Technology Series; Format; Subject Matter; Target Audience; I: Introduction to Process Validation; 1 Introduction to Process Validation (PV); Defining Process Validation (PV); Legacy Products; Stages of PV; Notes; 2 A Brief Review of the Regulations; Notes; 3 The Validation Life Cycle and Change Control; Life Cycle Approach; The Role of Change Control; Types of Changes; The Change Control Process; Notes.

II: Stage I-Process Development4 Getting Started; Before It All Starts; Example; Getting Started (After the Equipment Specifications); The Validation Master Plan; Standard Operating Procedures (SOPs) Preparation; Quality Programs; Training; Basic Risk Approach; Putting it Together; Notes; 5 Basic Equipment and Utility Qualification; Introduction; Determining the Level of Qualification; Factory Acceptance Test and Site Acceptance Test; Commissioning; Qualification Protocols-Installation Qualification (IQ) and Operational Qualification (OQ); Performance Qualification.

Laboratory Equipment Qualifica…