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Description
In recent years, regulatory inspections have focused on laboratory testing performed to assess the quality attributes of a product. In many cases, the testing is so specialized or complex, that the entire responsibility for validation has been transferred to the laboratory personnel. This excellent guide and reference provides an overview of validation from a laboratory perspective.
Divided into three parts: Part 1 includes an overview of many of the laboratory support systems and equipment common to both microbiology and chemistry laboratories. Part 2 is dedicated to systems applicable specifically to the chemistry laboratory, and Part 3 covers the systems applicable to microbiology laboratories. Where the laboratory predominantly performs the test, for example, cleaning and disinfection, requirements are included within the text.
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