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Essential Elements for a GMP Analytical Chemistry Department

  • Thomas Catalano

Table of contents

  1. Front Matter
    Pages i-xiv
  2. Thomas Catalano
    Pages 1-2
  3. Thomas Catalano
    Pages 3-24
  4. Thomas Catalano
    Pages 25-110
  5. Thomas Catalano
    Pages 111-136
  6. Thomas Catalano
    Pages 137-149
  7. Thomas Catalano
    Pages 151-166
  8. Thomas Catalano
    Pages 167-169
  9. Thomas Catalano
    Pages 171-174
  10. Thomas Catalano
    Pages 175-179
  11. Back Matter
    Pages 181-195

About this book

Introduction

Essential Elements for a GMP Analytical Chemistry Department identifies the essential elements required for a successful GMP Analytical Department to function as an efficient and effective organization. It describes in detail a department structure which allows for the necessary processes to become available to all its personnel in a way where there is a free flow of information and interaction, thereby encouraging the sharing of ideas, skills, and abilities among department personnel.  The essential elements such as , SOP’s, regulatory guidance’s/guidelines, project teams, technical and department processes, statistical concepts, personnel motivation, outsourcing, and hiring the best is among the many topics that are discussed in detail and how they can be implemented to build an efficient and effective Analytical Department. Essential Elements for a GMP Analytical Chemistry Department can be an asset to many companies required to perform GMP analytical method development, validation, analyses, documentation, etc…

Keywords

GMP SOP operating guidance regulatory guidance

Authors and affiliations

  • Thomas Catalano
    • 1
  1. 1.PharmChem Analytical Consultants LLCBuffalo GroveUSA

Bibliographic information

Industry Sectors
Pharma
Chemical Manufacturing
Biotechnology
Consumer Packaged Goods