The FDA & worldwide current good manufacturing practices and quality system requirements: guidebook for finished pharmaceuticals / Jose Rodriguez-Perez
Material type:
TextPublication details: Milwaukee, Wisconsin : ASQ Quality Press, c2016Description: vii, 369 pages : illustrations ; 24 cmISBN: 9788174890429Subject(s): DRUG INDUSTRY | DRUG STANDARDS | PHARMACEUTICAL PREPARATIONSLOC classification: RS 192 .R63 2016
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LRC - Main | National University - Manila | Pharmacy | General Circulation | GC RS 192 .R63 2016 (Browse shelf (Opens below)) | c.1 | Available | NULIB000011928 |
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| GC RS 189 .W67 2016 WHO Expert Committee on specializations for pharmaceutical preparations : fiftieth report / | GC RS 192 .B56 2004 Bioavailability and bioequivalence in pharmaceutical technology / | GC RS 192 .L33 2013 Lachman/Lieberman's the theory and practice of industrial pharmacy / | GC RS 192 .R63 2016 The FDA & worldwide current good manufacturing practices and quality system requirements: guidebook for finished pharmaceuticals / | GC RS 192 .S74 1991 vol.2 Sterile pharmaceutical manufacturing : applications for the 1990's / | GC RS 199.S73 .A36 2011 LWW's foundations in sterile products for pharmacy technicians / | GC RS 199.S73 .A54 2010 Sterile drug products : formulation, packaging, manufacturing, and quality / |
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.
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