Qualification and validation activities

Our activities are carried out by a specialized department, with classified operators from the point of view of radiation protection.

ITELPHARMA performs qualification of classified environments, insulators, shielded cells for handling and dispensing radiopharmaceuticals, shielded cells for synthesis modules, synthesis modules, autoclaves, pass-through devices, refrigerators and climatic chambers. ITELPHARMA can provide its own test laboratories for the development and validation of analytical methods for chemical and microbiological quality control; procedures for cleaning and disinfection of premises classified, Cleaning Validation and Process Validation.

These activities are carried out by a specialized department, with classified operators from the point of view of radiation protection.

The Qualification is aimed at checking in a documented way that a system under control, that performs a specific process, is correctly installed, properly operational, properly repeatable and reliable.

The qualification operation cannot be replaced by the supplier’s test of the system,  as the latter activity is to verify that the installed system is working from the point of view of electrical / mechanical within specification limits imposed by the manufacturer of the system, but not ensuring the quality, efficiency and reproducibility of the production process. The latter is established only with specific tests within the qualification process itself and using as a benchmark the acceptance criteria values required by the end user.

The Validation is the process by which it is established, by laboratory studies, that the performance of a process that involves critical activities meets the requirements for those applications in which the process is designed.

It is a planned sequence of experiments made to demonstrate that the analyzed processes are suitable for the application for which they were developed, and that the obtained results are consequently reliable.

Validation activities of fundamental importance are addressed to: Analytical methods for the analysis of the finished product or raw materials; production processes; procedures for disinfection of contamination control; procedures for the cleaning of surfaces of production equipment directly in contact with raw materials and finished products.

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