The FDA & worldwide current good manufacturing practices and quality system requirements: guidebook for finished pharmaceuticals /
Jose Rodriguez-Perez
- Milwaukee, Wisconsin : ASQ Quality Press, c2016
- vii, 369 pages : illustrations ; 24 cm.
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
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.