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Pharmaceutical Quality Systems (Hardcover)
Loot Price: R5,156
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Pharmaceutical Quality Systems (Hardcover)
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When a pharmaceutical company decides to build a Quality System, it
has to face the fact that there aren't any guideline that define
exactly how such a system has to be built. With terms such as
quality system, quality assurance, and quality management used
interchangeably, even defining the system's objectives is a
problem. This book provides a practical guide to building a quality
system. Beginning with explanations of key terms and concepts, it
covers ISO 9000 and GMP and how to combine them, and includes a
matrix showing their similarities and differences. Implementation
reviews illustrate how Quality (Management) Systems have been
installed successfully in pharmaceutical companies. Also covered
are the individual components of a Quality System; auditing,
validation, and supplier qualification systems; and Hazard Analysis
Critical Control Points (HACCP).
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