PDF Download Essential Elements for a GMP Analytical Chemistry Department, by Thomas Catalano
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Essential Elements for a GMP Analytical Chemistry Department, by Thomas Catalano
PDF Download Essential Elements for a GMP Analytical Chemistry Department, by Thomas Catalano
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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.
- Sales Rank: #3858289 in eBooks
- Published on: 2013-06-20
- Released on: 2013-06-20
- Format: Kindle eBook
From the Back Cover
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…
About the Author
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.Most helpful customer reviews
2 of 2 people found the following review helpful.
An excellent guidance on setting up and maintaining an efficient cGMP analytical laboratory
By Zhengtian Gu
I would recommend this book to everyone working in CMC, not only the analytical chemists, which are the obvious audience of this book, but also the scientists and managers in pharmaceutical science and chemical development. This book provides an detailed overview on what is necessary to establish an efficient analytical development and quality control organization, all the requirements, in documentation, process, and scientific concept.
This book discusses various functions of Analytical Development organization, such as HPLC method development, method validation, and method transfer, provided guidances on the specification development, stability program, reference standard program and training program.
This is a must have for Lab Managers and QC/Analytical chemists, and anyone who wants to understand what takes to run an analytical chemistry department.
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