Quality assurance of pharmaceuticals : a compendium of guidelines and related materials : vol. 2 - Good manufacturing practices and inspection / WHO World Health Organization
- Second updated edition
- iv, 409 p. ; il : 24 x 16 cm.
WHO good manufacturing practices: main principles for pharmaceutical products -- Quality management in the drug industry: philosophy and essential elements (update on sampling) (new) -- Heating ventilation and air-conditioning systems for non-sterile pharmaceutical dosage formas (new) -- Validation (new) -- Water for pharmaceutical use (new) -- WHO good manufacturing practices: starting materials -- Active pharmaceutical ingredients (bulk drug substances) -- Pharmaceutical excipients -- WHO good manufacturing practices: specific pharmaceutical products -- Sterile pharmaceutical products -- Biological products -- Investigational pharmaceutical products for clinical trials in humans -- The manufacture of herbal medicines (updated) -- Radiopharmaceutical products -- Inspection -- Pre-approval inspections -- Inspection of pharmaceutical manufacturers -- Inspection of drug distribution channels -- Quality systems requirements for national good manufacturing practice inspectorates -- Guidance on good manufacturing practices: inspection report -- Model certificate of good manufacturing practices -- Hazard and risk analysis in pharmaceutical producs -- Application of hazard analysis and critical control point (HACCP) methodology to pharmaceuticals -- Sampling operations (new) -- Sampling of pharmaceutical products and related material (new) -- Index --
92 4 154708 1 -- 978 92 4 154708 6
Farmacologia
Medicamentos
Terapeutica--química
Droga y control narcótico--estándares
Industria farmaceutica--normas
Industria de droga--estándares
Control de drogas y narcoticos
Control de calidad
Gravamen de riesgos--métodos
Preparación farmacéutica--estándares
Productos biológicos--estándares
Medicina
Salud
615.19 / W551qu
WHO good manufacturing practices: main principles for pharmaceutical products -- Quality management in the drug industry: philosophy and essential elements (update on sampling) (new) -- Heating ventilation and air-conditioning systems for non-sterile pharmaceutical dosage formas (new) -- Validation (new) -- Water for pharmaceutical use (new) -- WHO good manufacturing practices: starting materials -- Active pharmaceutical ingredients (bulk drug substances) -- Pharmaceutical excipients -- WHO good manufacturing practices: specific pharmaceutical products -- Sterile pharmaceutical products -- Biological products -- Investigational pharmaceutical products for clinical trials in humans -- The manufacture of herbal medicines (updated) -- Radiopharmaceutical products -- Inspection -- Pre-approval inspections -- Inspection of pharmaceutical manufacturers -- Inspection of drug distribution channels -- Quality systems requirements for national good manufacturing practice inspectorates -- Guidance on good manufacturing practices: inspection report -- Model certificate of good manufacturing practices -- Hazard and risk analysis in pharmaceutical producs -- Application of hazard analysis and critical control point (HACCP) methodology to pharmaceuticals -- Sampling operations (new) -- Sampling of pharmaceutical products and related material (new) -- Index --
92 4 154708 1 -- 978 92 4 154708 6
Farmacologia
Medicamentos
Terapeutica--química
Droga y control narcótico--estándares
Industria farmaceutica--normas
Industria de droga--estándares
Control de drogas y narcoticos
Control de calidad
Gravamen de riesgos--métodos
Preparación farmacéutica--estándares
Productos biológicos--estándares
Medicina
Salud
615.19 / W551qu