This Handbook of Manufacturing: Regulations and Quality focuses on all regulatory aspects and requirements that govern how drugs are produced for evaluation (and, later, sale to and use in) humans. The coverage ranges from what the issues are at the early stages (when the amounts are small and the materials of limited sophistication) up to until the issue is reproducibly and continuously making large volumes of a highly sophisticated manufactured product. These 25 chapters cover the full range from preformulation of a product (the early exploratory work that allows us to understand how to formulate and deliver the drug) to identifi cation of sources of contamination and assessment.
