TY - BOOK AU - Rodriguez-Perez, Jose TI - The FDA & worldwide current good manufacturing practices and quality system requirements: guidebook for finished pharmaceuticals SN - 9788174890429 AV - RS 192 .R63 2016 PY - 2016/// CY - Milwaukee, Wisconsin PB - ASQ Quality Press KW - DRUG INDUSTRY N1 - Includes bibliographical references and index; Introduction -- US current good manufacturing practice -- International good manufacturing practice -- Global good manufacturing practice guides and harmonization -- Detailed analysis of the requirements and guidances -- Missing subparts -- What are inspectors looking for? -- Quality at Risk: the price of noncompliance N2 - Good manufacturing practice for human pharmaceuticals affects every individual who takes medicine. Consumers expect that the medicines they take will meet quality standards and will be safe and effective ER -