Quality Systems and Controls for

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.

Dipak K. Sarker, School of Pharmacy and Biomolecular Sciences University of Brighton, UK

Preface	p. xi
List of figures	p. xv
List of tables	p. xix
Glossary of terms and acronyms	p. xxi
Glossary of mathematical and statistical symbols	p. xxiii
Most Suitable Environment	p. 1
Introduction	p. 3
The process of finding new lead medicines	p. 4
A drug discovery framework	p. 6
Technology transfer and the climate of change	p. 11
Innovation and research	p. 11
Method transfer	p. 14
Quality systems structure and a maximum quality environment	p. 15
The quality gurus and models for assurance	p. 18
A cycle of continual improvement	p. 22
Management structure and a functioning department	p. 22
Setting Process Bounderies	p. 29
Validation	p. 31
Process and manufacturing validation activities	p. 35
Valid analytical methodologies (VAMs)	p. 43
Good manufacturing practices	p. 57
Manufacture of standard products	p. 60
Manufacture of materials requiring specialised production facilities	p. 75
Quality assurance aspects of medical gases, devices and miscellaneous product manufacture	p. 88
Process control via numerical means	p. 97
Charting and quality inspection	p. 99
Sampling plans	p. 104
Measures of process compliance and variation	p. 108
Product verification and the role of qualified personnel	p. 111
Batch documentation	p. 113
Standard operating procedures	p. 114
Guides, overviews and validation plans	p. 115
The duties of the qualified person	p. 116
In-process and on-process QC testing and control	p. 119
Process analytical technologies	p. 120
Analytical validation and clinical test validation (CTV)	p. 121
LIMS and automation	p. 126
Starting from Scratch	p. 131
Applications of QA to new medicinal products and new chemical entities formulation	p. 133
Start-up and initialisation	p. 134
Raw materials control	p. 134
The validation life cycle	p. 134
Top-down or bottom-up validations	p. 135
New products manufacturing	p. 137
From inception to market place	p. 139
New product development: product design and specification	p. 146
Questions and problems	p. 151
Specimen examples and exam questions	p. 151
Model answers to examples	p. 162
References	p. 169
Index	p. 177
Table of Contents provided by Ingram. All Rights Reserved.

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Quality Systems and Controls for Pharmaceuticals

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