Novità Legislative e Normative


Annexes to: CMPM/ICH/283/95 Impurities: Guideline for residual solvents

Guide line on the declaration of the quantitative composition/labeling of biological medicinal products that contain modified proteins as active substance

Concept paper on the need for a reflection pqper on quality aspects of medicines for older people.


Importation of active substances for medicinal products for human use – Q&A ver 4.0.

Human Pharmaceutical Committee Maeeting of March 27, 2013

Guidelines on the principles of Good Distribution Practices for Active Substances for Medicinal Products for Human Use.


Recommendations  for Labelling Medicinal Products to inform users that the product or product container is not made with natural rubber latex

Glass syringes for delivering drug and biological products technical information to supplement intenational organizations for Standardization (ISO) Standard 11040-4

Tablet scoring. Nomenclature, Labeling and Data for Evaluation


Validacao de limpeza para farmoquimica.


Technical Report on Process Validation.