Abstract
D&MD' s Guide to Good Validation Practice, 3rd Edition is devoted to
considering in greater detail the ways of complying with validation
requirements at all stages of drug research, development and manufacture. The
particular problems associated with the newer biopharmaceutical products are
given special consideration. To complete this comprehensive guide to
validation and its problems, full texts are provided of the major guidelines
issued by National and International regulatory authorities, along with the
relevant abstracts from the GLP, GMP, and GCP regulations. Other references
include web sites for the retrieval of the text of regulations and guidelines,
a list of useful publications, and of some well-known firms specializing in
validation consulting.
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