000 01278nam a2200229Ia 4500
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
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
300 _avii, 369 pages :
_billustrations ;
_c24 cm.
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
999 _c14169
_d14169