Análise do trabalho de qualificação de fornecedores de insumos farmacêuticos da Unidade Farmanguinhos / Analysis of the work of qualification of suppliers of pharmaceutical ingredients Unit Farmanguinhos

Considerando a estreita relação entre a lógica econômica e as necessidades da área de saúde, o estudo em questão interliga o trabalho de Qualificação de Fornecedores de Insumos Farmacêuticos com o desempenho produtivo das Indústrias Farmacêuticas no contexto do Complexo Industrial da Saúde. Como objetivo evidencia o inter-relacionamento de ordem administrativa, técnica e operacional, frente o desempenho articulado entre os Procedimentos internos adotados por Farmanguinhos, seus processos de Aquisição, Validação, Manufatura e Inovação de Medicamentos, e a Qualidade e Especificidade dos Insumos Farmacêuticos adquiridos, demonstrando dentro desta ambiência, o impacto promovido pelo Trabalho de Qualificação de Fornecedores, em conformidade com os requisitos de qualidade visando às Boas Práticas de Fabricação. Como referencial teórico e regulatório, fundamenta além do contexto econômico, político e institucional capitalista associado à produção de bens e serviços do Complexo Industrial da Saúde, a representatividade da Indústria Farmacêutica frente à balança comercial nacional e desenvolvimento econômico, a conexão de conformidades entre os trabalhos de Validação e as Boas Práticas de Fabricação, bem como a interdependência entre a especificidade dos insumos farmacêuticos, seus processos de aquisição pelo setor público e os trabalhos de qualificação de fornecedores, tudo no âmbito da cadeia de produção de medicamentos. O impacto destes fundamentos frente à dinâmica administrativa, técnica e operacional produtiva de Farmanguinhos é evidenciado por informações oriundas de pesquisa exploratória, documental e de campo, empregada na metodologia de intervenção. Na análise de campo foram evidenciados procedimentos adotados por Farmanguinhos, relacionados com a aquisição pela administração pública e com a qualificação de fornecedores de insumos farmacêuticos, apresentando diagnóstico dos índices de reprovações das matérias-primas e medicamentos manufaturados...

Considering the relation between the economic logic and the necessities of the health area, the study in subject establishes connection the Raw Pharmaceutical Suppliers Qualification’s Work with the productive performance of the Pharmaceutical Industries in the context of the Health Industrial Complex. As objective it evidences the Inter-relationship of administrative, operational and technique orders, front of the articulated performance of the internal Procedures adopted by Farmanguinhos, its processes of Acquisition, Validation, Manufacture and Innovation of Medicines, and the Quality Specified Raw Pharmaceutical acquired, demonstrating inside of this environment, the impact promoted for the Suppliers Qualification’s Work, in compliance with the Good Manufacturing Practices quality requirements. As regulatory and theoretician referential, it bases beyond the economic, politician and institutional capitalist context associated with the production of goods and services of the Health Industrial Complex, the representation of the Pharmaceutical Industry front to the national trade balance and economic development, the connection of conformity between the Validation’s work and the Good Manufacturing Practices, as well as the interdependence enters the specificity of the Raw Pharmaceutical, its public acquisition processes and the supplier qualification works, everything in the scope of the chain of medicine production. The impact of these bases front to the Farmanguinhos administrative, productive and operational technique dynamics is evidenced by deriving information of exploratory research, documentary and of field, used in the intervention methodology. In the field analysis procedures adopted for Farmanguinhos had been evidenced, related with the acquisition for the public administration and with the Raw Pharmaceutical Suppliers Qualification’s Work presenting diagnostics of the raw materials and manufactured medicines disapprove index...

Efecto del tiempo de almacenamiento a -18ºC sobre las características bacteriológicas y físico-químicas de filetes de pez volador (Dactylopterus volitans) / The Effect of Time on Bacteriological, Physical and Chemical Characteristics of Flying Gurnards Fish´s Fillets (Dactylopterus volitans) under Frozen Storage at -18°C

Parte del producto de la pesca se devuelve al mar aunque pudiera comercializarse. Tal es el caso del pez volador (Dactylopterus volitans), debido a que su morfología dificulta su manipulación. Este estudio tuvo por objetivo evaluar el efecto del tiempo sobre las características bacterianas y físico-químicas en filetes del pez volador almacenados a -18°C durante 6; 39; 67 y 95 días. Se realizaron recuentos (UFC/g) de aerobios mesófilos a 25 y 32°C y de Staphylococcus aureus y determinación del NMP/g de coliformes fecales y Escherichia coli. También se determinó humedad, pH y el índice de rancidez. El tiempo de almacenamiento bajo congelación no ejerció ningún efecto en los recuentos bacterianos, pues no se halló evidencia significativa (P > 0,05) de multiplicación o disminución de los mismos. Los recuentos de aerobios mesófilos en placa fueron bajos, no hubo crecimiento de S. aureus y el valor más alto de coliformes fecales fue de 240 NMP/g. Sin embargo, los valores de rancidez oxidativa y de pH si fueron significativamente diferentes (P < 0,05) durante el lapso de almacenamiento. El índice del ácido tiobarbitúrico varió de 0,27 hasta 3,12 mg de malonaldehído/kg debido, probablemente a la interacción de diversos factores, entre ellos, a los fragmentos de piel que quedaron en los filetes, presencia de sustancias pro-oxidantes y a las fluctuaciones de temperatura durante el almacenamiento. A pesar del incremento de la rancidez, la apariencia y el olor no indicaron deterioro. Se concluye que esta especie pudiera comercializarse bajo la modalidad de filetes siempre y cuando a los filetes se les elimine completamente la piel, se glaseen, se empaquen herméticamente y se vigilen las temperaturas de almacenamiento.

A part of the fish captured is discarded despite the fact that it could be commercialized. This is the case of flying gurnards´s fish (Dactylopterus volitans) because its morphology difficults its handling, even though it is eaten in differents forms. The objective of this research was to determine the effect of time on the bacteriological, physical and chemical characteristics of gurnard fillets kept in storage at -18°C during 6; 39; 67 and 95 days. Mesophilic aerobic plate counts (CFU/g) were made at 25 and 32°C and S. aureus. Also the most probable number (MPN/g) of fecal coliforms and E. coli was determined. Humidity was likewise determined, together with pH and the rancidity index. There was not evidence that the frozen storage´s days are a significant factor (P > 0.05) in the bacterial counts. Bacteriological results confirmed that during the processing steps hygienic and temperature norms were followed, since the aerobic plate counts were low, S. aureus did not grow and the highest number of fecal coliforms was 240 MPN/g. On the other hand, the frozen storage´s time influences significantly (P < 0.05) the lipid oxidation´s rate in frozen fillets because the thiobarbituric acid index oscillated from 0.27 to 3.12 mg malonaldehyde/kg, probably due to some skin fragments in the fillets, substances with pro-oxidative propierties and for temperature fluctuations in the storage. Nevertheless, in despite of rancidity increase, the appearance and the odor did not show signs of spoiling. In conclusion, this species could be commercialized in the form of fillets provided that the freezing, defrosting and storage temperatures are watched at all times. It is highly recommended that the fillets are fully peeled, glazed and packed air tight.