Quality Systems and Control for Pharmaceuticals

by Madjackfrost on October 4, 2009

This book hopes to answer some of the questions asked by undergraduates and industrialists that are coming to the area of industrial pharmaceutics, pharmaceutical science and industrial pharmaceutical practice. The subject matter can at times be terse, full of jargon and rather dry, but also intrinsically diverse, and an appreciation requires a solid grounding in subjects covered at lower level during a diploma or degree programme.

Quality Systems and Control for PharmaceuticalsThe principle aims of this text are to target undergraduates (foundation degrees, BSc pharmaceutical sciences), postgraduates (MPharm, MSc (specialisms), PgDip, etc.), industrialists, practicing clinicians, researchers and scientists making the transition to industry and to also serve in support of in-house short-course training events.

Some topics such as ‘documentation’ and ‘auditing’ are not given sections but are incorporated into other areas; these particular topics are covered in the quality assurance (QA) section, which comes under validation and manufacturing. Likewise ‘raw materials’ and ‘microbiology’ appear under GMP/hygiene and marginally under analytical testing. Process analytical technology (PAT) is covered under cGMP (current good manufacturing practice) and good laboratory practice (GLP). ‘Biotechnology’ appears under the title of biopharmaceuticals.

Overview of the book:

Quality Systems and Control for Pharmaceuticals is an accessible overview of the highly-regulated area of pharmaceutical manufacture, the production of biomedical materials, and biomedical devices. Introducing the subject in a clear and logical manner it enables the reader to grasp the key concepts of the multidisciplinary area of control science and specifically quality control using industrial and theoretical models.

Taking a multidisciplinary approach to the subject the reader is guided through key topics such as product safety which takes into account aspects of analytical science, statistics, microbiology, biotechnology, engineering, business practice and optimizing models, the law and safeguarding public health, innovation and inventiveness and contemporary best practice.

The author has both industry and academic experience and many ‘best practice’ examples are included throughout the text based on his own industry experience and current practicing industrial pharmacists. This is an invaluable reference for all students of pharmacy who may have little or no familiarity with industrial practice and for those studying BSc chemistry, biomedical sciences, process analytical chemistry and MSc in Industrial Practice.

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{ 2 comments… read them below or add one }

ravinder January 20, 2011 at 1:54 pm

pharma back ground

Mallikarjuna Rao November 2, 2011 at 2:52 am

its very useful for pharma

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