ABSTRACT
In the Œrst edition of this book, published in 2000, we posed the question: Why did we decide to produce yet another book on validation? The same response is still applicable: Guidelines addressing validation are usually purposefully broad to allow for the variability in products, manufacturing methods, analysis, clinical indications, patient populations, and doses for biopharmaceuticals. As a result, there is still much discussion related to validation approaches and speciŒc issues that must be addressed to satisfy regulatory authorities and produce safe and efŒcacious biopharmaceuticals. Furthermore, developing technologies, both analytical and manufacturing, can impact validation and it is expected that sponsors of biopharmaceuticals will remain current with new developments.
