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Good Manufacturing Practice Regulatory

Discovery targets S receptors, small molecule drugs, large molecule drugs [Pg.211]

Development Methodologies following GLP-pharmaco-dynamics, pharmacokinetics, toxicology, drug delivery systems [Pg.211]

Chapter 9 Good Manufacturing Practice Regulatory Requirements [Pg.212]

On a global level, GMP regulations are very similar for various countries. There are, however, differences in emphasis and implementation in specific areas. We will explain the GMP regulations from the United States, Europe and the International Conference on Harmonization (ICH) in this chapter. In Chapter 10, we will discuss the manufacturing processes for synthetic and protein-based drugs. [Pg.212]

GMP regulations came into effect in the US in 1963. They have since undergone several major revisions. The implementation of GMP is the result of a number of tragedies to ensure that drugs are safe for the patients and effective for treatments. Some of these tragedies are described in Exhibit 9.1. [Pg.212]

GOOD MANUFACTURING PRACTICE REGULATORY REQUIREMENTS TABLE 9.6 Storage Conditions for Evalnating Drng Stability... [Pg.310]

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