000 | 01278nam a2200229Ia 4500 | ||
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003 | NULRC | ||
005 | 20250520102734.0 | ||
008 | 250520s9999 xx 000 0 und d | ||
020 | _a9788174890429 | ||
040 | _cNULRC | ||
050 | _aRS 192 .R63 2016 | ||
100 |
_aRodriguez-Perez, Jose _eauthor |
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245 | 4 |
_aThe FDA & worldwide current good manufacturing practices and quality system requirements: _bguidebook for finished pharmaceuticals / _cJose Rodriguez-Perez |
|
260 |
_aMilwaukee, Wisconsin : _bASQ Quality Press, _cc2016 |
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300 |
_avii, 369 pages : _billustrations ; _c24 cm. |
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365 | _bUSD100 | ||
504 | _aIncludes bibliographical references and index. | ||
505 | _aIntroduction -- 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 | ||
520 | _aGood 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. | ||
650 | _aDRUG INDUSTRY | ||
942 |
_2lcc _cBK |
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999 |
_c14169 _d14169 |