Qualification and Validation Activities

The Design Qualification (DQ) aims to make a preliminary verification of the suitability of a diagnostic structure or Nuclear Medicine department project, in terms of correct and effective combination of production plants, diagnostic machines, complementary systems and all related equipment. If the analyzed project is suitable for the purpose, or if the arrangement and combination of all these elements is deemed (on paper) suitable for the production of radiopharmaceuticals compliant with the User Specifications (URS) described by the GMP, the Design Qualification can be issued and the implementation of the implant, and therefore with the production of the drug, can proceed. The BeForPharma team, with its experience of issuing different DQ authorizations, has the skills and professionalism within it to provide all the necessary checks and to compile the supporting documentation, in compliance with the requirements of Annex 15 of the GMP. It is therefore able to issue the Design Qualification and the authorization for the implementation of the production plant.

Before starting the production of a radiopharmaceutical, it is necessary to validate the entire production process, i.e. verify its repeatability, safety and sensitivity. Given the intrinsic characteristics of radiopharmaceuticals, and in particular the shortness of the half-life cycle, BeForPharma implements a step-by-step validation process: well-timed controls upstream avoid any unnecessary waste of time and allow the almost immediate release of the drug, in total safety. The purpose of the validation is to provide documented evidence that a specific radiopharmaceutical production process allows the output (radiopharmaceutical product) to obtain 100% the specifications and quality attributes predefined and required by the regulations (FDA 1987).

Sterile conditions are an indispensable requirement of the environments in which radiopharmaceuticals are produced: the handling of raw materials and the final product – administered intravenously – must take place in properly sanitized cleanrooms. BeForPharma examines the environments before the production process is started, to ensure that they comply with the dictates of the Good Manufacturing Practice (GMP) and certifies the degree of contamination (or, hopefully, non-contamination) of all surfaces and air according to the ISO standard norms on particle contamination and microbiological contamination: in particular ISO 14644 for non-viable particulate contaminants and ISO 14698 regarding contamination by live microorganisms. In addition, it carries out careful monitoring of the already classified environments for its customers.

The validation of the chemical and microbiological analytical methods is performed by highly qualified personnel who first draw up a customized protocol based on the type of production, and then perform the specific tests of specificity, linearity and anything else necessary to confirm a quality production.

BeForPharma carries out qualification and re-qualification activities on the tools and equipment used in production and quality control. Having a team of multidisciplinary experts made up of chemists, biologists, engineers and specialized technicians, the team is able to validate the layout of the equipment placed inside the radiopharmaceutical facilities. In particular, the team verifies that the equipment has been installed correctly and that they are able to operate according to specification, i.e. that they are, before their use, in a state of valid qualification, according to the provisions of GMPs and NBP-MNs.