000 02883nam a22004697a 4500
008 140202b ck ||||| |||| 00| 0 spa d
020 _a92 4 154708 1 -- 978 92 4 154708 6
082 0 4 _a615.19 / W551qu
110 1 _aWHO - World Health Organization
_994155
245 1 0 _aQuality assurance of pharmaceuticals : a compendium of guidelines and related materials : vol. 2 - Good
245 1 0 _amanufacturing practices and inspection / WHO World Health Organization
250 _aSecond updated edition
264 _aGinebra : WHO - World Health Organization, 2007
300 _aiv, 409 p. ; il : 24 x 16 cm.
505 0 0 _aWHO good manufacturing practices: main principles for pharmaceutical products -- Quality management in the
505 0 0 _adrug industry: philosophy and essential elements (update on sampling) (new) -- Heating ventilation and
505 0 0 _aair-conditioning systems for non-sterile pharmaceutical dosage formas (new) -- Validation (new) -- Water for
505 0 0 _apharmaceutical use (new) -- WHO good manufacturing practices: starting materials -- Active pharmaceutical
505 0 0 _aingredients (bulk drug substances) -- Pharmaceutical excipients -- WHO good manufacturing practices: specific
505 0 0 _apharmaceutical products -- Sterile pharmaceutical products -- Biological products -- Investigational
505 0 0 _apharmaceutical products for clinical trials in humans -- The manufacture of herbal medicines (updated) --
505 0 0 _aRadiopharmaceutical products -- Inspection -- Pre-approval inspections -- Inspection of pharmaceutical
505 0 0 _amanufacturers -- Inspection of drug distribution channels -- Quality systems requirements for national good
505 0 0 _amanufacturing practice inspectorates -- Guidance on good manufacturing practices: inspection report -- Model
505 0 0 _acertificate of good manufacturing practices -- Hazard and risk analysis in pharmaceutical producs --
505 0 0 _aApplication of hazard analysis and critical control point (HACCP) methodology to pharmaceuticals -- Sampling
505 0 0 _aoperations (new) -- Sampling of pharmaceutical products and related material (new) -- Index --
650 1 4 _aFarmacologia
_9110402
650 1 4 _aMedicamentos
_9115950
650 1 4 _aTerapeutica
_xquímica
_9133133
650 1 4 _aDroga y control narcótico
_xestándares
_9107324
650 1 4 _aIndustria farmaceutica
_xnormas
_9113146
650 1 4 _aIndustria de droga
_xestándares
_9113113
650 1 4 _aControl de drogas y narcoticos
_9104763
650 1 4 _aControl de calidad
_9104755
650 1 4 _aGravamen de riesgos
_xmétodos
_9111906
650 1 4 _aPreparación farmacéutica
_xestándares
_9128374
650 1 4 _aProductos biológicos
_xestándares
_9128831
650 1 4 _aMedicina
_9115965
650 1 4 _aSalud
_9130891
710 1 _aOMS - Organización Mundial de la Salud (Ginebra)
_993454
999 _c24354
_d24354