Quality assurance of pharmaceuticals : a compendium of guidelines and related materials : vol. 2 - Good manufacturing practices and inspection / WHO World Health Organization
By: WHO - World Health Organization
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Contributor(s): OMS - Organización Mundial de la Salud (Ginebra).
Ginebra : WHO - World Health Organization, 2007 Edition: Second updated edition.Description: iv, 409 p. ; il : 24 x 16 cm.ISBN: 92 4 154708 1 -- 978 92 4 154708 6.Subject(s): 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 | SaludDDC classification: 615.19 / W551qu | Item type | Current location | Collection | Call number | Vol info | Copy number | Status | Notes | Date due | Barcode | Item holds |
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Libros
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Biblioteca Ciencias de la Salud | FONDO BIBL | 615.19 / W551qu (Browse shelf) | 8001 | 1 | Available | DO | 8300004872 |
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 --
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