This handbook describes the regulatations and quality control issues that are key to pharmaceutical manufacturing. Covering details like the FDA in the US, intrernational regulation, good manufacturing practice (GMP), and process analytical technology (PAT); the book thoroughly exposes professional manufacturers and engineers to the key issues they need to understand in order to properly do their jobs. In addition, the book covers quality assurance and validation, drug stability, and contamination control -- aspects that are heavily influenced by regulatory guidelines.