The Design Qualification (DQ) aims to make a preliminary verification of the suitability of a project in terms of the correct and effective combination of production plants, diagnostic machines, complementary systems and all related equipment.
Provided the project analyzed is suitable for the purpose, or if the combination of all these elements is deemed (on paper) suitable for the production of radiopharmaceuticals conforming to the User Specification (URS) described by the GMP, the Design Qualification can be issued and implementation of the plant, and therefore the production of the drug, can proceed.
The BeForPharma team, with its experience of issuing different DQ authorizations, has within it the skills and professionalism to provide all the necessary checks and to compile the supporting documentation, in compliance with the provisions of Annex 15 of the GMP.
After careful assessment of the risks, of a documented comparison between the client’s needs and the technical specifications of the materials supplied, and of the project’s correspondence to the specific authorization protocols, BeForPharma proceeds with the issue of a Design Qualification and implementation authorization of the production plant.
