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Essential Elements for a GMP Analytical Chemistry Department by Thomas Catalano

Essential Elements for a GMP Analytical Chemistry Department

by Thomas Catalano
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Book cover type: Hardcover
  • ISBN13: 9781461476412
  • Binding: Hardcover
  • Subject: N/A
  • Publisher: Springer
  • Publisher Imprint: Springer
  • Publication Date:
  • Pages: 195
  • Original Price: EUR 149.99
  • Language: English
  • Edition: 2013
  • Item Weight: 363 grams
  • BISAC Subject(s): Pharmacy, Chemistry / Analytic, and Chemistry / Organic

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...

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 (glycopeptideantibiotic).

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

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