Main steps for radiopharmaceuticals hot cells validation in accordance with GMP requirements
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2018
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Journal of Environmental Science and Engineering A
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The worldwide GMP (Good Manufacturing Practices) guidelines issued for injectable pharmaceuticals globally agree that
the vials filling operation must be performed under air cleanliness Grade A. The air cleanliness classifications adopted by the WHO
(World Health Organization) define the particle diameter size, the sampling occupancy state and the limit concentration of viable
particles. To reach conformity regarding the microbial limits foreseen at the GMP guidelines, a microbiological monitoring program
must be stablished for selected sampling points such as active air sampling, passive air sampling (settle plate method), surfaces
sampling (contact method), personnel sampling (gloves and clothes), compressed gas, materials and equipment that may interfere and
compromise the product microbiological quality. The key elements for a GMP certification are directly related to a qualification and
validation program for radiopharmaceutical manufacturers that must be clearly defined and documented by a validation master plan,
foreseen by the manufactures Quality Assurance office. This study describes each qualification step and test for DQ (Design
Qualification), IQ (Installation Qualification), OQ (Operation Qualification) and PQ (Performance Qualification) that must be carried
out and carefully planned when it comes to hot cells and isolator systems in accordance with the GMP requirements foreseen by
international regulatory and supervisory bodies.
Como referenciar
CAMPOS, FABIO E. de; PERINI, EFRAIN A.; ZAPPAROLI JUNIOR, CARLOS L.; CALVO, WILSON A.P.; STAROVOITOVA, VALERIIA N. Main steps for radiopharmaceuticals hot cells validation in accordance with GMP requirements: methodology and practical guide. Journal of Environmental Science and Engineering A, v. 7, p. 132-139, 2018. DOI: 10.17265/2162-5298/2018.03.004. Disponível em: http://repositorio.ipen.br/handle/123456789/29285. Acesso em: 23 Apr 2024.
Esta referência é gerada automaticamente de acordo com as normas do estilo IPEN/SP (ABNT NBR 6023) e recomenda-se uma verificação final e ajustes caso necessário.