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Nuclear Medicine

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With the entry into force of the Guidelines on Good Radiopharmacy Practices for Nuclear Medicine (GRP-NM), and with the Pharmacopoeia changes, it is necessary for compliance with those specifications for all private and public institutions that deal with such preparations.

The verification and demonstration of compliance to GRP-NM is developed through various stages to demonstrate that the production facility is able to ensure quality, efficacy and safety of production for a complete protection of the patient.

CTP SYSTEM, with specific expertise, can support the facilities in the GRP-NM certification through its services of design, validation, support for quality system and microbiological problems (analysis and media-fill).

CTP SYSTEM services:

  • QUALITY AREA
    development of quality assurance systems
    preparation and review of procedures / operating instructions
    risk analysis on processes and environments
    process validation and media fill
    QA “on demand”
  • ENGINEERING AND QUALIFICATION AREA
    environmental design and classifications
    qualification and validationenvironmental monitoring
  • LAB AREA
    analytical methods validation
    sterility and LAL test
    supply of culture media and Media Fill analysis
    microbial identifications
    environmental controls

readmore NUCLEAR MEDICINE pdf

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For information:
Silvio Temperini
Mob. +39 348 6504078
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Poggibonsi (Siena)

Località Salceto, 91/93
Tel. +39 0577 98481
Fax +39 0577 980762

Milano

Via Stephenson, 94
Tel. +39 02 49681311
Fax +39 02 49681344

Pomezia (Roma)

Via Pontina Km 29
Tel. +39 06 83668111
Fax + 39 06 83668144

Contact

Email info@ctpsystem.com

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