Sense and nonsense of quality assurance in an R&amp;D environment

Vermaercke, P.

doi:10.1007/s007690050002

Cited by 27 publications

(11 citation statements)

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“…A process that starts with the main goal of obtaining a compliance declaration or certification, rather than achieving real quality improvement, will be poorly accepted and certainly misunderstood by technical and scientific staff [10]. In our case, we feel that our GLP implementation has been successful for several reasons: probably the most important was that the system was developed 'bottom-up' involving staff at all levels, rather than the 'topdown' approach of managerial imposition [12]. Secondly, it is the good science and technical competence of staff within the EVL and QAU, hand-in-hand with GLP principles, which brought us to achieve compliance [10,13].…”

Section: Discussionmentioning

confidence: 89%

Implementation of Good Laboratory Practice in a university research unit

2005

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Section: Discussionmentioning

confidence: 89%

Implementation of Good Laboratory Practice in a university research unit

2005

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“…Over the years, the scientific community has discussed about the benefits of applying international quality standards to research activities. The real challenge is then to create a reasonably simple and flexible QMS that combines the creativity of the researcher and the international quality standard [22][23][24][25][26]. Under these premises, IFC seems to be an ideal place to apply the international quality standards adopted for radiopharmaceuticals production to research activities.…”

Section: Process Validationmentioning

confidence: 99%

Implementation of a quality assurance system according to GMP and ISO 9001:2008 standard for radiopharmaceutical production in a public research centre

et al. 2012

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The production of pharmaceuticals is one of the most highly regulated fields in terms of quality. The body of good manufacturing practice (GMP) represents the standard required by law; GMP embraces the guidelines that regulate all activities related to the production and quality control of medicinal products for human and veterinary use. This paper deals with the implementation of a quality management system (QMS) in compliance with GMP and ISO 9001 standards for the production and distribution of radiopharmaceuticals in a public research institute. The production of 2-[18F]fluoro-2-deoxy-D-glucose has been implemented according to GMP standards and has been licensed by the national Authority in 2007. In 2010, a project to orient the system's GMP compliance to ISO 9001 standards has been approved. A QMS conforming to ISO 9001:2008 should be considered an important additional step in terms of quality, because ISO 9001 also takes into account economic and financial aspects, design and development aspects and introduces management review for measurement and analysis of the process with the aim of improving performances. The harmonization between GMP and ISO has been defined following the Pharmaceutical Quality System Q10 guideline developed by International Conference on Harmonization.

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“…In general, there are some determining factors for the successful implementation of QMS in R&D environments, including: the acceptance and commitment of all professionals involved to the so-called ''quality culture'' [27], the development of a flexible documentation system, and, most importantly, the structuring of a self-sustaining QMS system that is capable of adding value to the institution [27,28].…”

Section: Final Considerationsmentioning

confidence: 99%

Implementation of Good Laboratory Practices (NIT-DICLA-035, Inmetro) in a technological platforms network: the Fiocruz experience

et al. 2011

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The technological platforms network (TPN) of the Oswaldo Cruz Foundation was developed as the result of the need to provide technical and scientific services to the Brazilian public health and health research networks through the use of high cost, state-of-the-art, multiuser equipment. In order to improve the quality of the services offered, a quality management system (QMS) was implemented in a group of subunits of the TPN. To achieve the planned objectives, a review of all the existing guidelines was carried out first, which led to the choice of a Brazilian guideline: Inmetro NIT-DICLA-035, ''Good Laboratory Practices'' (GLP). The next steps were the choice of the platform subunits (Pilot Project), the drafting of relevant documentation, and the creation of a quality assurance structure as well as other activities. It was clear that a proper interpretation and understanding of GLP in these platforms could make a difference in the efficacy and effectiveness of the system defined. The expertise gained through the implementation of QMS in the Pilot Project has enabled GLP implementation in the other TPN subunit platforms.

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Sense and nonsense of quality assurance in an R&D environment

Cited by 27 publications

References 0 publications

Implementation of Good Laboratory Practice in a university research unit

Implementation of Good Laboratory Practice in a university research unit

Implementation of a quality assurance system according to GMP and ISO 9001:2008 standard for radiopharmaceutical production in a public research centre

Implementation of Good Laboratory Practices (NIT-DICLA-035, Inmetro) in a technological platforms network: the Fiocruz experience

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