The radio-pharmaceutical manufacturing requires the implementation and monitoring of the most strictly and highly quality standards and regulations. Qualipharma offers comprehensive support to ensure its accomplishment and therefore to create a healthy, safe and productive work environment backed with required documentation for every critical process where radio-pharmaceuticals products are involved.

Thanks to the good results achieved during these years, Qualipharma supports nowadays the 90% of the total amount of companies in the radio-pharmaceutical sector in Spain. We guide them during the development and implementation of their quality plans with complete support in all their processes such as radioactive isotope production, commercialization and dispatch of radio-pharmaceutical products in hospitals. With high prestige and recognition given by AEMPS and our clients, Qualipharma is one of the strongest companies in the sector.

Some of the services that we fully provide are:
At hospitals radio-pharmacy units:

  • Clean room qualification.
  • Laminar flow cabinets / radioisotope cells qualification.

 

At central radio-pharmacy units:

  • Clean room qualification.
  • Laminar flow cabinets / radioisotope cells qualification.
  • Measuring instruments calibration.
  • Consulting services for GMP implementation and accomplishment for manufactures of radio-pharmaceutical products.
  • Consulting services for GDP implementation and accomplishment for stockade and transportation of radio-pharmaceutical products.
  • GMP and GDP audits for supplier’s accreditation.
  • Internal audits.

    At radio-pharmaceutical production plants PET:

        • Clean room qualification.
        • Laminar flow cabinets / radioisotope cells qualification.
        • Measuring instruments calibration.
        • Equipment Qualification.
        • Installation and preventive maintenance of the synthesis modules.
        • Preventive maintenance of cyclotrons.
        • Audits and advisory service for maintenance plans.
        • Comprehensive technical support of radio-pharmaceutic production equipment.
        • Consulting services for GMP accomplishment related to radio-pharmaceutical products manufactures.
        • Consulting services for GDP accomplishment related to the stockade and transportation of radio-pharmaceutical products.
        • Internal audits.
        • Management of new products registration dossier.
        • Management of Investigational Medicinal Product Dossier (IMPD).
        • Management of application dossier for radio-pharmaceutical products in special situations (compassionate use).
        • Management of application dossier for scientific consultancy services given by the EMEA.
        • Variations and validations.
        • Consulting services and support on tender applications for radio-pharmaceutical products supply.
        • Training courses (GMP accomplishment related to radiopharmaceutical products manufacturing and quality control, use and maintenance of cyclotrons, use and maintenance of synthesis module, etc. …).

     

    Qualipharma offers customized services according to each client needs. We can integrate our services to your manufacturing process in order to ensure the continuity of your production.