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WHO Expert Committee on Specifications for Pharmaceutical Preparations

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76.00
The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines.

Standards are developed by the Committee through worldwide consultation and an international consensus-building process.

The following new guidelines were adopted and recommended for use:

WHO guidelines on good herbal processing practices for herbal medicines;
Guidelines on good manufacturing practices for the manufacture of herbal medicines;
Considerations for requesting analysis of medicines samples;
WHO model certificate of analysis;
WHO guidance on testing of ?suspect? falsified medicines;
Good pharmacopoeial practices ? Chapter on monographs for compounded preparations;
Good pharmacopoeial practices ? Chapter on monographs on herbal medicines;
Guidelines on heating, ventilation and air-conditioning systems for non-sterile pharmaceutical products;
Guidance on good practices for desk assessment of compliance with good manufacturing practices, good laboratory practices and good clinical practices for medical products regulatory decisions;
Stability testing of active pharmaceutical ingredients and finished pharmaceutical products; and
Collaborative procedure in the assessment and accelerated national registration of pharmaceutical products and vaccines approved by stringent regulatory authorities.
Materias
ISBN
978-92-412-1019-5
EAN
9789241210195
Stock
NO
Idioma
Inglés
Nivel
Profesional
Formato
Encuadernado
Tapa Dura
Páginas
418
Largo
240
Ancho
170
Peso
-
Edición
Fecha de edición
25-06-2018
Año de edición
2018
Nº de ediciones
52
Colección
-
Nº de colección
-