Thomas Catalano

Essential Elements for a GMP Analytical Chemistry Department (eBook, PDF)

• Format: PDF

Produktbeschreibung

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...

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Produktdetails

• Verlag: Springer US
• Seitenzahl: 195
• Erscheinungstermin: 20. Juni 2013
• Englisch
• ISBN-13: 9781461476429
• Artikelnr.: 43793821

Autorenporträt

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.

Inhaltsangabe

Introduction.- Organization.- Department Structure.- Project Teams.- Responsibilities.- Interactions.- Operating Guidance's.- Processes.- Safety.- Technology.- Department.- Statistical Concepts for the Analytical Chemist.- Data distribution.- Significance Testing.- Confidence Intervals.- Outliers in analytical data.- Regression.- Experimental design.- Required sample replicates.- Method performance.- Uncertainty measurement.- Sampling strategies.- Outsourcing.- Process.- Audit Check List.- Documentation.- Sample Submission.- Technical Report.- Reports of analysis.- Records (Training etc.).- Job Descriptions.- Career Tracks.- Motivating Personnel.- Career Path.- Hiring the Best.