INSTITUTO TECNOLÓGICO PET

Esta web utiliza cookies para obtener datos estadísticos de la navegación de sus usuarios. Si continúas navegando consideramos que aceptas su uso. Más información X Cerrar

Fluotracer:

1110 MBq/ml, injectable solution, Marketing Authorisation Nº 64.781 from the Spanish Agency of Medicines and Health Products. In 11 ml / 25 ml vials and National Reference Nº 745430 / 745448 respectively.

Fluodos:

1110 MBq/ml, injectable solution, Marketing Authorisation Nº 65.223 from the Spanish Agency of Medicines and Health Products. In 11 ml / 25 ml vials and National Reference Nº 743781 / 743799 respectively.

Contracer:

1110 MBq/ml, injectable solution, Marketing Authorisation Nº 5355185 from the Portuguese National Institute of Pharmacy and Medicines (INFARMED) - the Portuguese Ministry of Health. In 25 ml. vials.

Metascan:

1110 MBq/ml, injectable solution, Marketing Authorisation Nº 5345147 from Portuguese National Institute of Pharmacy and Medicines (INFARMED) - the Portuguese Ministry of Health. In 25 ml. vials.

(18F) Sodium Fluoride:

Supplied when special authorisation for compassionate use has been received in advance from the Medicines Agency in the applicant country. Currently being authorised and registered.

(18F) F-Colina:

Supplied when prior special authorisation for compassionate use has been received from the Medicines Agency in the applicant country. Currently being authorised and registered.

(18F) F-Miso:

Manufactured in industrial R&D facilities, in line with R&D GMPs laid down by the Spanish Agency of Medicines and Health Products, it is supplied for preclinical and clinical tests.

(18F) FLT:

Manufactured in industrial R&D facilities, in line with R&D GMPs laid down by the Spanish Agency of Medicines and Health Products, it is supplied for preclinical and clinical tests.

(18F) MPPF:

Manufactured in industrial R&D facilities, in line with R&D GMPs laid down by the Spanish Agency of Medicines and Health Products, it is supplied for preclinical and clinical tests.

(18F) F-Dopa:

Manufactured in industrial R&D facilities, in line with R&D GMPs laid down by the Spanish Agency of Medicines and Health Products, it is supplied for preclinical and clinical tests.


	As a producer of radiopharmaceuticals, the facilities of the ITP laboratory are duly licensed by the Spanish Agency of Medicines and Health Products for its activities as a: - Holder of a Radiopharmaceutical Medicine Marketing Authorisation - Manufacturer of radiopharmaceutical medicines for human use and manufacturer of medicines used in research. - Importer of medicines. Ever since 1995, PET Technical Institute has been working towards the 100% implementation of quality and environmental standards by continually improving its Quality Guarantee Management System, which includes Environmental Management. Quality is demanded of us, it enables us to guarantee compliance with current compulsory legislation in the sphere of Good Manufacturing Practice (GMP); Good Laboratory Practice (GLP), Radiological Protection Standards, Good Clinical Practice, Personal Data Protection, Pharmacovigilance Systems and Clinical Monitoring of Patients, amongst others. The model adopted by PET Technical Institute allows us to observe the relationships between the processes described. The parties concerned have a significant role to play in defining such requirements at the outset. Monitoring the satisfaction of the parties concerned requires an evaluation of information relating to the perception of whether or not the organisation has complied with its requirements.

As a producer of radiopharmaceuticals, the facilities of the ITP laboratory are duly licensed by the Spanish Agency of Medicines and Health Products for its activities as a:

- Holder of a Radiopharmaceutical Medicine Marketing Authorisation
- Manufacturer of radiopharmaceutical medicines for human use and manufacturer of medicines used in research.
- Importer of medicines.

Ever since 1995, PET Technical Institute has been working towards the 100% implementation of quality and environmental standards by continually improving its Quality Guarantee Management System, which includes Environmental Management. Quality is demanded of us, it enables us to guarantee compliance with current compulsory legislation in the sphere of Good Manufacturing Practice (GMP); Good Laboratory Practice (GLP), Radiological Protection Standards, Good Clinical Practice, Personal Data Protection, Pharmacovigilance Systems and Clinical Monitoring of Patients, amongst others.

The model adopted by PET Technical Institute allows us to observe the relationships between the processes described. The parties concerned have a significant role to play in defining such requirements at the outset. Monitoring the satisfaction of the parties concerned requires an evaluation of information relating to the perception of whether or not the organisation has complied with its requirements.


In a world of limited resources, the PET technique saves time and money; it even allows us to replace various current diagnostic techniques by eliminating unnecessary medicines and surgical interventions. Taking compulsory compliance with current standards (GMPs) as our starting point, the ITP Laboratory always guarantees the Quality, Safety, Efficiency and Information of its products. Therefore, when manufacturing our products and providing our services, the prime Quality objective is to achieve and maintain customer satisfaction. To that end, we continually monitor the 4 parameters mentioned above, using tools defined in the Quality Guarantee Management System such as In-house Inspection processes; Pharmacovigilance processes, Risk Control processes; Supplier Approval processes; Shipment of Products to the Client processes, amongst others. ITPís procedures are validated and revalidated on an ongoing basis, thereby achieving the REITERATION of the product specifications and of the service supplied to the client, and achieving the total traceability of all processes.

In a world of limited resources, the PET technique saves time and money; it even allows us to replace various current diagnostic techniques by eliminating unnecessary medicines and surgical interventions.

Taking compulsory compliance with current standards (GMPs) as our starting point, the ITP Laboratory always guarantees the Quality, Safety, Efficiency and Information of its products. Therefore, when manufacturing our products and providing our services, the prime Quality objective is to achieve and maintain customer satisfaction. To that end, we continually monitor the 4 parameters mentioned above, using tools defined in the Quality Guarantee Management System such as In-house Inspection processes; Pharmacovigilance processes, Risk Control processes; Supplier Approval processes; Shipment of Products to the Client processes, amongst others.

ITPís procedures are validated and revalidated on an ongoing basis, thereby achieving the REITERATION of the product specifications and of the service supplied to the client, and achieving the total traceability of all processes.

LABORATORY
Instituto Tecnológico PET

C/ Manuel Bartolomé Cossío nº 10 28040-Madrid.

Tel.: 91 534 48 96

DIAGNOSTICS
Instituto Tecnológico de Servicios Sanitarios
C/ Gómez Hemans 2-4, planta -1 28033 Madrid.

Tel.: 91 178 17 60