Título: | METROLOGICAL CONTROL IN THE PHARMACEUTICAL INDUSTRY: CONTRIBUTION TO MANAGEMENT OF CALIBRATION LABORATORIES OF PROCESS INSTRUMENTS | ||||||||||||||||||||||||||||||||
Autor: |
WILLIANS DOS ANJOS PINTO PORTELLA |
||||||||||||||||||||||||||||||||
Colaborador(es): |
MAURICIO NOGUEIRA FROTA - Orientador |
||||||||||||||||||||||||||||||||
Catalogação: | 01/AGO/2005 | Língua(s): | PORTUGUESE - BRAZIL |
||||||||||||||||||||||||||||||
Tipo: | TEXT | Subtipo: | THESIS | ||||||||||||||||||||||||||||||
Notas: |
[pt] Todos os dados constantes dos documentos são de inteira responsabilidade de seus autores. Os dados utilizados nas descrições dos documentos estão em conformidade com os sistemas da administração da PUC-Rio. [en] All data contained in the documents are the sole responsibility of the authors. The data used in the descriptions of the documents are in conformity with the systems of the administration of PUC-Rio. |
||||||||||||||||||||||||||||||||
Referência(s): |
[pt] https://www.maxwell.vrac.puc-rio.br/projetosEspeciais/ETDs/consultas/conteudo.php?strSecao=resultado&nrSeq=6720&idi=1 [en] https://www.maxwell.vrac.puc-rio.br/projetosEspeciais/ETDs/consultas/conteudo.php?strSecao=resultado&nrSeq=6720&idi=2 |
||||||||||||||||||||||||||||||||
DOI: | https://doi.org/10.17771/PUCRio.acad.6720 | ||||||||||||||||||||||||||||||||
Resumo: | |||||||||||||||||||||||||||||||||
The development of metrological reliability has received in
recent years increasingly
attention from metrologists. Confidence in measurements is
a prerequisite in the
manufacturing of pharmaceutical products The present
Master`s Dissertation
formulates an integrated managerial model for dealing with
metrological reference
measuring standards (étalons) used in the pharmaceutical
sector. In full compliance
with international standards and best laboratory practices,
the proposed model
incorporates the monitoring of performance of standards and
instruments used
during two successive calibrations. The work is based on a
search related to the best
current laboratorial practices developed in connection with
laboratorial management
in their relation with traditional calibration labs of
process instruments operating in
the pharmaceutical industry. In this context, the proposed
model incorporates the
following lines of analysis considered as essential
ingredients in the proposed
metrological reliability approach: (i) management of
metrological standards; (ii)
evaluation of the relevance of the process instrumentation
for quality control; (iii)
management for non-conformity treatment; (iv) management of
the frequency of
calibration of the process instruments; (v) management of
the calibration in the
manufacturing process and (vi) management of the
calibration in the validation of
the critical processes of the pharmaceutical industry. 36
among the most traditional
pharmaceutical labs located in the states of Rio de Janeiro
and São Paulo -
responsible for nearly 70% of all pharmaceutical products
in the country - were
selected for the survey. For the sake of metrological
analyses, each one of the 6
requisites listed above, was based on assessment criteria
which included quality,
productivity and metrological reliability.
|
|||||||||||||||||||||||||||||||||
|