Essential Elements for a GMP Analytical Chemistry Department

1. Front Matter

   Pages i-xiv

   PDF

2. Introduction

   • Thomas Catalano

   Pages 1-2

3. Organization

   • Thomas Catalano

   Pages 3-24

4. Processes

   • Thomas Catalano

   Pages 25-110

5. Statistical Concepts for the Analytical Chemist

   • Thomas Catalano

   Pages 111-136

6. Outsourcing

   • Thomas Catalano

   Pages 137-149

7. Documentation

   • Thomas Catalano

   Pages 151-166

8. Job Descriptions

   • Thomas Catalano

   Pages 167-169

9. Motivating Personnel

   • Thomas Catalano

   Pages 171-174

10. Hiring the Best

    • Thomas Catalano

    Pages 175-179

11. Back Matter

    Pages 181-195

    PDF

 Essential Elements for a GMP Analytical Chemistry Department is a systematic approach to understanding 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. The environment and culture created by this approach encourages and rewards 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, 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. This book will serve as a valuable asset to the many companies required to perform GMP analytical method development, validation, analyses etc including start-up, virtual, and generic pharmaceutical companies. ​

• GMP
• SOP
• operating guidance
• regulatory guidance

• PharmChem Analytical Consultants LLC, Buffalo Grove, USA

  Thomas Catalano

Dr. Tom Catalano’s has 30 years in the Pharmaceutical Industry in various positions including the Global Director of Analytical R&D,  with major companies such as G.D. Searle, Pharmacia and Pfizer, which led to a multitude of experience in providing analytical support to dosage forms and drug substances including biologicals. Additionally, he worked for a biopharmaceutical company, Theravance, as Sr. Director of Technical Operations.

He provided analytical support to a variety of dosage forms and drug substances, which included:

Tablets, Soft Capsules, Hard Capsules, Creams and Gels Injectables (Suspensions, Solutions or Lyophilized) Controlled Release Forms (Oral and Injectable) Manufacture of small molecules, peptides and proteins

In Dr. Catalano’s 30 years in the industry, he made significant contributions to the development and registration of many products such as NutraSweet, Cytotec, Arthrotec, Celebrex, Bextra, Dynastat, Inspra and Vibativ (glycopeptide antibiotic).

Currently Dr. Catalano is president of a consulting company, PharmChem Analytical Consultants LLC.

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