Good Manufacturing Practice (cGMP)

On the bases of European Community recent Regulations and Directives, manufacturing and importation of all medicinal products for human use, including advanced therapy medicinal products, have to be produced in accordance with the principles and guidelines of current cGMP.

The directives also state that principles of Good Manufacturing Practice are to be adopted as detailed guidelines.

The different production operations need to be conducted in accordance with established instructions and procedures and in accordance with cGMP.

Procelltech provides Quality Control assays in full compliance with cGMP standards and with procedures adapted for somatic cell therapy products.

Procelltech facilities and working processess are in full compliance with good manufacturing practice requirements and have been inspected by Italian Health Authorities.