Validação de limpeza de zidovudina: estratégia aplicada ao processo de fabricação de medicamentos anti-retrovirais

Alencar, João Rui Barbosa de; Ramos, Selma Verônica Vieira; Machado, Líbia Bentes; Oliveira, Amanda Tatiane Costa; Monteiro, Deborah Bezerra; Medeiros, Flávia Patrícia Morais de; Rolim-Neto, Pedro José

doi:10.1590/s1516-93322004000100003

Cited by 3 publications

(6 citation statements)

References 3 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…It is possible to observe in the literature great results achieved through the application of quality tools in companies in the chemical industry. These results include, for example, the reduction in the cost of maintaining physical-chemical analysis equipment (Miranda and Santana, 2018), the identification and resolution of failures in the production of ethanol from sugarcane (Medeiros and Silva, 2017), in the control of procedures adopted in the production of medicines to meet the strict quality requirements (Alencar et al, 2004), and even solve quality problems that occur in pulp and paper producing companies (Tzaskos and Gallardo, 2016).…”

Section: The Quality Toolsmentioning

confidence: 99%

“…The CEP shows the variability of a parameter and makes it possible to control the process over time (Alencar et al, 2004). Through it, it is possible to determine whether or not the established process is under control, that is, whether there are anomalies that interfere with the procedure in such a way that there is an impact on the controlled results.…”

Section: Consolidated Quality Toolsmentioning

confidence: 99%

“…Through it, it is possible to determine whether or not the established process is under control, that is, whether there are anomalies that interfere with the procedure in such a way that there is an impact on the controlled results. In the CEP there are control charts through which it is possible to detect deviations in such parameters (Alencar et al, 2004). In this way, it is possible to take corrective action and quickly reduce the quantity of out-of-spec products.…”

Section: Consolidated Quality Toolsmentioning

confidence: 99%

See 2 more Smart Citations

Routine and quality management in the chemical industry

Vieira¹,

Fontes²,

Silva³

2023

Development and Its Applications in Scientific Knowledge

View full text Add to dashboard Cite

The work shows the importance of routine management, performance, and quality in chemical industry companies. To this end, the necessary factors for application are described, in addition to showing better results when routine management is used. In this study, successful cases were used and a breakdown of the main indicators was exposed. The main results were the reduction of maintenance cost of physical and chemical analysis equipment, the reuse of organic waste, the resolution of failures in the production plant, the control of production procedures, and the resolution of failures in the pulp and paper industry.

show abstract

Section: The Quality Toolsmentioning

confidence: 99%

Section: Consolidated Quality Toolsmentioning

confidence: 99%

Section: Consolidated Quality Toolsmentioning

confidence: 99%

See 1 more Smart Citation

Routine and quality management in the chemical industry

Vieira¹,

Fontes²,

Silva³

2023

Development and Its Applications in Scientific Knowledge

View full text Add to dashboard Cite

show abstract

“…Some studies of methods for validation of equipment cleaning have been described (Alencar et al, 2004(Alencar et al, , 2006aAndrade, 2012;Bago, 2010). Many industries seek a common denominator for grouping similar products, and by this process, they aim to turn a complex situation into a manageable project.…”

Section: Descriptive Termmentioning

confidence: 99%

Determination of the worst case for cleaning validation of equipment used in the radiopharmaceutical production of lyophilized reagents for 99mTc labeling

Porto

Fukumori

Matsuda

2016

Braz. J. Pharm. Sci.

View full text Add to dashboard Cite

Cleaning validation, a requirement of the current Good Manufacturing Practices (cGMP) for Drugs, consists of documented evidence that cleaning procedures are capable of removing residues to predetermined acceptance levels. This report describes a strategy for the selection of the worst case product for the production of lyophilized reagents (LRs) for labeling with 99mTc from the Instituto de Pesquisas Energéticas e Nucleares (IPEN-CNEN/São Paulo). The strategy is based on the calculation of a "worst case index" that incorporates information about drug solubility, cleaning difficulty, and occupancy rate in the production line. It allowed a reduction in the required number of validations considering the possible manufacturing flow of a given product and the subsequent flow, thus facilitating the process by reducing operation time and cost. The products identified as "worst case" were LRs PUL-TEC and MIBI-TEC.Uniterms: Radiopharmaceuticals/production. Drugs/manufacturing/cleaning validation. Lyophilized reagents.A validação de limpeza é uma exigência dos atuais regulamentos de Boas Práticas de Fabricação de Medicamentos (BPF) e consiste na evidência documentada, que demonstra que os procedimentos de limpeza removem os resíduos em níveis de aceitação pré-determinados. Este estudo apresenta uma estratégia para escolha do produto "pior caso" da linha de produção de reagentes liofilizados para marcação com 99m Tc do Instituto de Pesquisas Energéticas e Nucleares (IPEN-CNEN/São Paulo). A estratégia baseiase no cálculo de um índice denominado "índice para pior caso," que utiliza informações de solubilidade dos fármacos, dificuldade de limpeza dos equipamentos e ocupação dos produtos na linha de produção. A estratégia adotada proporcionou a diminuição no número de validações necessárias, considerando-se as possibilidades de sequências de fabricação de um determinado produto e do produto subsequente, possibilitando a simplificação do processo e redução no tempo e nos custos das atividades envolvidas. Os produtos indicados como pior caso foram os reagentes liofilizados (RL) PUL-TEC e MIBI-TEC.Unitermos: Radiofármacos/produção. Medicamentos/fabricação/validação de limpeza. Reagentes liofilizados.

show abstract

“…Alguns trabalhos têm sido realizados com enfoque na metodologia de validação de limpeza de equipamentos (ALENCAR et al, 2004;CLEMENTINO;NETO, 2006;ANDRADE, 2012;BAGO, 2010). Muitas indústrias buscam um denominador comum para que produtos similares possam ser agrupados, e através deste processo tentam converter uma situação complexa num projeto gerenciável.…”

Section: Estabelecimento Do Pior Caso Para Validação De Limpeza Dos Eunclassified

Estudo do pior caso na validação de limpeza de equipamentos de produção de radiofármacos de reagentes liofilizados. Validação de metodologia de carbono orgânico total

Porto¹

View full text Add to dashboard Cite

Radiopharmaceuticals are defined as pharmaceutical preparations containing a radionuclide in their composition, mostly intravenously administered, and therefore compliance with the principles of Good Manufacturing Practices (GMP) is essential and indispensable. Cleaning validation is a requirement of the current GMP, and consists of documented evidence, which demonstrates that the cleaning procedures are able to remove residues to predetermined acceptance levels, ensuring that no cross contamination occurs. A simplification of cleaning processes validation is accepted, and consists in choosing a product, called "worst case", to represent the cleaning processes of all equipment of the same production area. One of the steps of cleaning validation is the establishment and validation of the analytical method to quantify the residue. The aim of this study was to establish the worst case for cleaning validation of equipment in the radiopharmaceutical production of lyophilized reagent (LR) for labeling with 99m Tc, evaluate the use of Total Organic Carbon (TOC) content as indicator of equipment cleaning used in the LR manufacture, validate the method of Non-Purgeable Organic Carbon (NPOC), and perform recovery tests with the product chosen as worst case.Worst case product's choice was based on the calculation of an index called "Worst Case Index" (WCI), using information about drug solubility, difficulty of cleaning the equipment and occupancy rate of the products in line production. The products indicated as "worst case" was the LR MIBI-TEC. The method validation assays were performed using carbon analyser model TOC-Vwp coupled to an autosampler model ASI-V, both from Shimadzu ® , controlled by TOC Control-V software. It was used the direct method for NPOC quantification. The parameters evaluated in the validation method were: system suitability, robustness, linearity, detection limit (DL) and quantification limit (QL), precision (repeatability and intermediate precision), and accuracy (recovery) and they were defined as follows: 4% acidifying reagent, 2.5 ml oxidizing reagent, 4.5 minutes integration curve time, 3 minutes sparge time and linearity in 40-1000 µgL-1 range, with correlation coefficient (r) and residual sum of minimum squares (r 2) greater than 0.99 respectively. DL and QL for NPOC were 14.25 ppb e 47.52 ppb respectively, repeatability between 0.11 and 4.47%; the intermediate precision between 0.59 and 3.80% and accuracy between 97.05 and 102.90%. The analytical curve for Mibi was linear in 100-800 µgL-1 range with r and r 2 greater than 0.99, presenting similar parameters to NPOC analytical curves. The results obtained in this study demonstrated that the worst-case approach to cleaning validation is a simple and effective way to reduce the complexity and slowness of the validation process, and provide a costs reduction involved in these activities. All results obtained in NPOC method validation assays met the requirements and specifications recommended by the RE 899/2003 Resolution from ANVISA to conside...

show abstract

Validação de limpeza de zidovudina: estratégia aplicada ao processo de fabricação de medicamentos anti-retrovirais

Cited by 3 publications

References 3 publications

Routine and quality management in the chemical industry

Routine and quality management in the chemical industry

Determination of the worst case for cleaning validation of equipment used in the radiopharmaceutical production of lyophilized reagents for 99mTc labeling

Estudo do pior caso na validação de limpeza de equipamentos de produção de radiofármacos de reagentes liofilizados. Validação de metodologia de carbono orgânico total

Contact Info

Product

Resources

About