Main steps for radiopharmaceuticals hot cells validation in accordance with GMP requirements

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dc.contributor.authorCAMPOS, FABIO E. de
dc.contributor.authorPERINI, EFRAIN A.
dc.contributor.authorZAPPAROLI JUNIOR, CARLOS L.
dc.contributor.authorCALVO, WILSON A.P.
dc.contributor.authorSTAROVOITOVA, VALERIIA N.
dc.coverageInternacionalpt_BR
dc.date.accessioned2018-11-29T13:04:52Z
dc.date.available2018-11-29T13:04:52Z
dc.date.issued2018pt_BR
dc.description.abstractThe 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.pt_BR
dc.format.extent132-139pt_BR
dc.identifier.citationCAMPOS, 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. <b>Journal of Environmental Science and Engineering A</b>, v. 7, p. 132-139, 2018. DOI: <a href="https://dx.doi.org/10.17265/2162-5298/2018.03.004">10.17265/2162-5298/2018.03.004</a>. Disponível em: http://repositorio.ipen.br/handle/123456789/29285.
dc.identifier.doi10.17265/2162-5298/2018.03.004pt_BR
dc.identifier.issn1934-8932pt_BR
dc.identifier.orcidaguardandopt_BR
dc.identifier.orcidhttps://orcid.org/0000-0002-4316-8335
dc.identifier.percentilfiSem Percentil
dc.identifier.percentilfiCiteScoreSem Percentil CiteScore
dc.identifier.urihttp://repositorio.ipen.br/handle/123456789/29285
dc.identifier.vol7pt_BR
dc.relation.ispartofJournal of Environmental Science and Engineering Apt_BR
dc.rightsopenAccesspt_BR
dc.subjectradiopharmaceuticals
dc.subjectproduction
dc.subjectquality assurance
dc.subjectregulations
dc.subjectstandards
dc.subjectmonitoring
dc.subjectquality control
dc.subjectinspection
dc.titleMain steps for radiopharmaceuticals hot cells validation in accordance with GMP requirementspt_BR
dc.typeArtigo de periódicopt_BR
dspace.entity.typePublication
ipen.autorEFRAIN ARAUJO PERINI
ipen.autorWILSON APARECIDO PAREJO CALVO
ipen.autorCARLOS LEONEL ZAPPAROLI JUNIOR
ipen.autorFABIO EDUARDO DE CAMPOS
ipen.codigoautor9691
ipen.codigoautor603
ipen.codigoautor424
ipen.codigoautor261
ipen.contributor.ipenauthorEFRAIN ARAUJO PERINI
ipen.contributor.ipenauthorWILSON APARECIDO PAREJO CALVO
ipen.contributor.ipenauthorCARLOS LEONEL ZAPPAROLI JUNIOR
ipen.contributor.ipenauthorFABIO EDUARDO DE CAMPOS
ipen.date.recebimento18-11pt_BR
ipen.identifier.fiSem F.I.pt_BR
ipen.identifier.fiCiteScoreSem CiteScore
ipen.identifier.ipendoc25072pt_BR
ipen.subtitulomethodology and practical guidept_BR
ipen.type.genreArtigo
relation.isAuthorOfPublication307728ba-f5be-4432-be6f-6ae9c8d445b5
relation.isAuthorOfPublication39f410f2-b7d6-46e9-95ed-3bc77a28004f
relation.isAuthorOfPublicationa07fd69d-5af1-4a66-8326-65b71ef03a19
relation.isAuthorOfPublicationb0e49a67-513b-4b16-aeb0-b6f1d9696579
relation.isAuthorOfPublication.latestForDiscoveryb0e49a67-513b-4b16-aeb0-b6f1d9696579
sigepi.autor.atividadeCAMPOS, FABIO E. DE:261:240:Spt_BR
sigepi.autor.atividadePERINI, EFRAIN A.:9691:110:Npt_BR
sigepi.autor.atividadeZAPPAROLI JUNIOR, CARLOS L.:424:110:Npt_BR
sigepi.autor.atividadeCALVO, WILSON A.P.:603:240:Npt_BR
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