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    CGMP Starter Guide
    CGMP Starter Guide
    CGMP Starter Guide
    Ebook55 pages30 minutes

    CGMP Starter Guide

    By Emmet Tobin

    4.5/5

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    Read preview

    About this ebook

    This concise book provides an introduction to Current Good Manufacturing Practices (aka cGMP). It introduces those who wish to work in regulated industries to GMP, highlighting key areas and practices. It is also a useful refresher for those with previous experience of cGMP. At less than 90 pages, it is a short but useful reference or refresher guide - perfect for introducing new people to cGMP culture.

    LanguageEnglish
    PublisherEmmet Tobin
    Release dateJun 14, 2016
    ISBN9781311413505
    CGMP Starter Guide
    Author

    Emmet Tobin

    A graduate of the University of Bradford, West Yorkshire and Waterford Institute of Technology. With over 10 years experience in both the Medical Device and Pharmaceutical Industries, I am extremely passionate about validation and endorsing its importance to the future growth of companies.My professional experience includes working as a device, development, and validation engineer. I have worked extensively on projects including equipment FATs, commissioning and validation, new product development and production transfers. I effectively bring the requirements of Design, Regulatory, Quality, Validation and Production together to provide technical and robust solutions. My approach is ethical, quality based, hands-on, and thorough. Validation is my key skill with a sharp awareness of Time, Cost and Quality, while delivering new products to meet business and customer needs.

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    Reviews for CGMP Starter Guide

    4.5/5

    10 ratings3 reviews

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    • 5/5
      Un excelente resumen de los temas del marco de buena practicas y sus diferentes variantes en industria farmacéutica y de dispositivos médicos
    • 5/5
      Great information. Very useful for the industry today for application is any field of Quality.

      1 person found this helpful

    • 5/5
      Concise and well-written, easy to understand introduction to the topic of cGMP. It is geared toward the medical/pharma industry but easily applicable to Cosmetics ISO 77216 if you just ignore the pharma-specific notes. Written for an international audience but very easy to apply if you are a US-based company as well.

      1 person found this helpful

    Book preview

    CGMP Starter Guide - Emmet Tobin

    cGMP Starter Guide

    Emmet Tobin

    Copyright © 2016 www.validationresources.org

    Author: Emmet Tobin

    All rights reserved.

    First Edition

    Published by Solo Validation Resources Limited

    Distributed by Smashwords

    This ebook is licensed for your personal enjoyment only. This ebook may not be re-sold or given away to other people. If you would like to share this ebook with another person, please purchase an additional copy for each person you share it with. If you’re reading this book and did not purchase it, or it was not purchased for your use only, then you should return to Smashwords.com and purchase your own copy. Thank you for respecting the hard work of this author.

    Ebook formatting by www.ebooklaunch.com

    This document is for general guidance purposes only.

    It is the responsibility of individuals, companies and organisations to implement the necessary legal and regulatory requirements relevant to their industry. Solo Validation Resources Limited will take no responsibility for the application or interpretation of this document.

    Visit us at www.ValidationResources.org

    CONTENTS

    About This Book

    What is GMP?

    GxP, cGxP and cGMP Explainer

    Definitions of GMP

    Benefits of GMP

    A Brief History of GMP

    Consequences of GMP Failures

    What is a Quality Management System?

    Eight Principles of Cgmp

    What is Adulteration?

    Quality Management Systems- A Closer Look

    The Aims of GMP (S-P-U-E)

    What Documents Are Subject to GMP?

    Focus Areas of GMP

    What EU Regulations Relate to GMP?

    Audits

    What is RFT?

    What is PDCA?

    What is 5S?

    Counterfeit Protections

    GDP

    Why GDP is Essential?

    Elements of GDP

    Common Acronyms

    Useful Definitions

    References

    ABOUT THIS BOOK

    This concise book provides an introduction to Current Good Manufacturing Practices (aka cGMP). It introduces those who wish to work in regulated industries to GMP, highlighting key areas and practices. It is also a useful refresher for those with previous experience of cGMP.

    WHAT IS GMP?

    Good Manufacturing Practices are a set of practices that are required in order to comply with industry standards and regulations.

    GMP helps to minimise the risks involved

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