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Melhoria da Produtividade das Análises efetuadas por HPLC: Automatização do Processo de Cálculo dos Resultados Finais
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Orientador(es)
Resumo(s)
Com a crescente substituição de operações manuais por sistemas informatizados na in-
dústria farmacêutica, tornou-se necessário garantir a existência de medidas e controlos que
assegurem a integridade dos dados gerados pelos sistemas, bem como a sua fiabilidade, exa-
tidão e segurança. Neste sentido, a correta validação dos sistemas informatizados desempe-
nha um papel fundamental.
O presente trabalho visa implementar o cálculo dos resultados finais de análises quan-
titativas efetuadas por Cromatografia Líquida de Alta Eficiência (HPLC), no software do sis-
tema de dados cromatográficos (CDS), substituindo as folhas de cálculo eletrónicas atual-
mente utilizadas no Laboratório de Controlo da Qualidade da empresa.
Seguindo o modelo de validação de sistemas informatizados da International Society for
Pharmaceutical Engineering, apresentado na Good Automated Manufacturing Practice 5, foram
efetuados 5 testes na etapa de Qualificação de Desempenho do software, de forma a garantir
o correto funcionamento das ferramentas e funcionalidades necessárias ao processo de imple-
mentação do cálculo.
A obtenção do resultado final de análises de quantificação por HPLC com recurso ao
software foi testada e validada na análise quantitativa de matérias-primas e todas as formas
farmacêuticas fabricadas na empresa, tendo sempre em conta os aspetos relativos à integri-
dade dos dados.
Da análise do risco efetuada ao processo cromatográfico atual, com recurso à folha de
cálculo para obtenção do resultado final, foram identificados 47 possíveis modos de falha, dos
quais se destaca a transcrição das áreas dos picos com um número de prioridade do risco
(NPR) de 48. Com uma única exceção, os modos de falha relativos à utilização da folha de
cálculo, são eliminados pela obtenção dos resultados no próprio software CDS.
Da análise do risco efetuada à utilização do software CDS para obtenção dos resultados
finais, foram identificados 8 possíveis modos de falha e as respetivas medidas a implementar.
Do estudo de quantificação da redução do risco operacional e, simultaneamente, dos
tempos de obtenção e verificação dos resultados, com recurso a dois métodos distintos, ob-
teve-se um decréscimo nestas métricas, maioritariamente, acima de 50%.
With the increasing replacement of manual operations by computerized systems in the pharmaceutical industry, it became necessary to guarantee that measures and controls are in place to ensure the integrity of data generated by the systems, as well as their reliability, ac- curacy, and security. The correct validation of computerized systems plays a fundamental role in this topic. The present work aims to implement the calculation of the final results of High-Perfor- mance Liquid Chromatography (HPLC) quantitative analyses, in the chromatographic data system (CDS) software, replacing the electronic spreadsheets currently used in the company's Quality Control Laboratory. Following the computerized systems validation model of the International Society for Pharmaceutical Engineering, presented in Good Automated Manufacturing Practice 5, 5 tests were performed during the software's Performance Qualification stage, to guarantee the correct functioning of the tools and functionalities necessary to the process of implementing the cal- culation. The final result of quantification analysis by HPLC, using the software, was tested and validated in quantitative analysis for raw materials and all pharmaceutical forms manufac- tured in the company, always taking in account Data integrity. From the risk analysis to the current chromatographic process, using the spreadsheet to obtain the final results, 47 possible failure modes were identified, where the transcription of peak areas stands out with a risk priority number (NPR) of 48. With a single exception, the failure modes related to the use of the spreadsheets, are eliminated by obtaining the results in the CDS software itself. From the risk analysis performed to the use of CDS software to obtain the final results, 8 possible failure modes and the respective measures to be implemented were identified. The quantification study of the reduction of the operational risk and, simultaneously, the time of obtaining and verifying the final results, performed using two different methods, showed a decrease in these metrics, mostly, above 50%.
With the increasing replacement of manual operations by computerized systems in the pharmaceutical industry, it became necessary to guarantee that measures and controls are in place to ensure the integrity of data generated by the systems, as well as their reliability, ac- curacy, and security. The correct validation of computerized systems plays a fundamental role in this topic. The present work aims to implement the calculation of the final results of High-Perfor- mance Liquid Chromatography (HPLC) quantitative analyses, in the chromatographic data system (CDS) software, replacing the electronic spreadsheets currently used in the company's Quality Control Laboratory. Following the computerized systems validation model of the International Society for Pharmaceutical Engineering, presented in Good Automated Manufacturing Practice 5, 5 tests were performed during the software's Performance Qualification stage, to guarantee the correct functioning of the tools and functionalities necessary to the process of implementing the cal- culation. The final result of quantification analysis by HPLC, using the software, was tested and validated in quantitative analysis for raw materials and all pharmaceutical forms manufac- tured in the company, always taking in account Data integrity. From the risk analysis to the current chromatographic process, using the spreadsheet to obtain the final results, 47 possible failure modes were identified, where the transcription of peak areas stands out with a risk priority number (NPR) of 48. With a single exception, the failure modes related to the use of the spreadsheets, are eliminated by obtaining the results in the CDS software itself. From the risk analysis performed to the use of CDS software to obtain the final results, 8 possible failure modes and the respective measures to be implemented were identified. The quantification study of the reduction of the operational risk and, simultaneously, the time of obtaining and verifying the final results, performed using two different methods, showed a decrease in these metrics, mostly, above 50%.
Descrição
Palavras-chave
sistemas informatizados integridade dos dados validação análise do risco Good Automated Manufacturing Practice 5