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Radiopharmacy | Progress Report 131
Quality control of production areas (hot cells and clean areas) by
radiopharmaceuticals collecting and measuring airborne particles
as well as microbiological contamination is
Quality Control is part of the Good Manufac- assessed with passive and active air sampling.
turing Practices (GMP) which is concerned to The quality of water used in different processes
sampling, specifications and testing, and also is also examined. Training of professionals
to organization, documentation and release of Nuclear Medicine also takes place in the
procedures which ensure that the necessary laboratories of the Quality Control. The staff of
and relevant tests are actually carried out and the Quality Control (QC) Laboratory is trained
the radiopharmaceutical drugs are not released and qualified and participates actively with
for use by the responsible radiopharmacist all the other groups in the maintenance of the
until their quality is guaranteed. Radiophar- ISO 9001-2015 Certification, in compliance
maceuticals are transported to the nuclear with GMP for radiopharmaceuticals. The QC
medicine services in accordance with the group is also engaged in the qualification of
radiation protection regulation. Nowadays, equipment, development and validation of
about 80,000 assays are executed in radio- analytical methodologies, validation of pro-
nuclides including eluates from radionuclide duction processes, observing the requirements
generators, ready to use radiopharmaceuticals, of the National Sanitary Surveillance Agency
non-radioactive components for labeling with (ANVISA) and it has also been participating in
a radionuclide, starting materials, packaging the development of new products.
materials and environmental monitoring at
the Radiopharmacy Center of IPEN-CNEN/SP. Research and Development
In order to evaluate if radiopharmaceuticals
comply with the specifications of national The area of Research and Development ap-
and international pharmacopoeias and offi- plied to Radiopharmacy at IPEN is divided into
cial standards for oral and parenteral human 6 different fields: Radionuclide generators;
administration(,) strict quality control tests Primary radioisotopes; Labeling of molecules
are performed. for diagnosis (PET and SPECT) and therapy;
lyophilized kits and quality control analytical
Specific tests that ensure purity, potency, methodologies.
product identity, biologic safety and efficacy
include physicochemical and biological tests: The main achievements are described as fol-
organoleptic characteristics, pH, particle size lows:
measurement, determination of radionuclid-
ic, radiochemical and chemical purity, cap- Radionuclide generators
99
sules dissolution testing, sterility, bacterial • Study of high activity Mo- 99m Tc gener-
endotoxin test, biodistribution and toxicity ators
studies, among others. The Quality Control • Study of different Sep-PaksÆ filters for
has adequate facilities with modern analyti- using in Mo/ 99m Tc generators
99
cal equipment for its activities. Instrumental
techniques as gamma counters, IR spectro- Primary radioisotopes
photometry, GC, ICP-OES, HPLC and gamma • Production method for Cu.
64
123
spectrometry with HPGe detector are used. • New target for I
Environmental monitoring is conducted in the
