Validação de instrumento para Registro do Processo de Enfermagem no atendimento pré-hospitalar móvel de urgência / Validación de un instrumento para el Registro del Proceso de Enfermería en la atención móvil de emergencia prehospitalaria / Validation of an instrument for the Nursing Process Record in prehospital mobile emergency care

Objetivo: validar a aparência e o conteúdo de um instrumento para Registro do Processo de Enfermagem no Serviço de Atendimento Móvel de Urgência. Método: estudo de abordagem quantitativa, em que o instrumento foi submetido à validação de aparência e conteúdo por comitê de 21 experts na área de atendimento pré-hospitalar móvel de urgência nacionalmente. Um Índice de Validade de Conteúdo (IVC) igual ou superior a 0,80 estabeleceu a validação. Resultados: obteve-se um IVC de 0,94. Apenas o item facilidade de leitura, relacionado à aparência, teve um índice abaixo do estabelecido. Foi possível avaliar as 99 intervenções de Enfermagem elencadas. Conclusão: o instrumento para Registro do Processo de Enfermagem no Serviço de Atendimento Móvel de Urgência foi considerado válido e pode possibilitar a documentação manual da prática do enfermeiro neste cenário.

Objective: face and content validation of an instrument for Recording the Nursing Process in the Mobile Emergency Care Service. Method: quantitative study of face and content validation of the instrument by a committee of 21 experts in the field of prehospital mobile emergency care nationwide. A Content Validity Index (CVI) equal to or greater than 0.80 determined validation. Results: a CVI of 0.94 was obtained. Only the item ease of reading, related to appearance, had an index below the established. It was possible to evaluate the 99 nursing interventions listed. Conclusion: the instrument for the Nursing Process Record in the Mobile Emergency Care Service was considered valid and can enable the manual documentation of nursing practice in this setting.

Objetivo: validación de apariencia y contenido de un instrumento para el Registro del Proceso de Enfermería en el Servicio de Atención Móvil de Emergencia. Método: estudio cuantitativo de validación facial y de contenido del instrumento por un comité de 21 expertos en el campo de la atención prehospitalaria móvil de emergencia a nivel nacional. Un Índice de Validez de Contenido (IVC) igual o superior a 0,80 determinó la validación. Resultados: se obtuvo un IVC de 0,94. Únicamente el ítem facilidad de lectura, relacionado con la apariencia, presentó índice por debajo de lo establecido. Fue posible evaluar las 99 intervenciones de enfermería listadas. Conclusión: el instrumento para el Registro del Proceso de Enfermería en el Servicio de Atención Móvil de Emergencia se consideró válido y puede posibilitar la documentación manual de la práctica de enfermería en este escenario.

Development And Validation Of Uv-Visible Spectrophotometric Method For Determination Of Duloxetine

Objective: The aim of the present work was to develop and validate a simple UV spectroscopic method for the determination of duloxetine, which is a thiophene derivative and a selective neurotransmitter reuptake inhibitor for serotonin, norepinephrine, and to lesser degree dopamine. Methods: The UV Spectrophotometric analysis was performed using Shimadzu UV-1800 and Shimadzu UV-1700 spectrophotometer by using solvent system acetonitrile and water in the ratio of 8:2. Detection was performed at a wavelength of 290 nm. Method validation was carried out according to ICH Q2R1 guidelines by taking the parameters linearity, accuracy, precision, ruggedness, and robustness, LOD and LOQ. Results: The UV Spectrophotometric method was found linear in the range of 10-50 μg/ml. The method was rugged and robust with % relative standard deviation less than 2. The extraction recoveries were found to be higher than 99% in all experimental conditions. Conclusion: Based upon the performance characteristics, the proposed method was found accurate, precise and rapid and suitable for the determination of Duloxetine for routine analysis.

Validação de um histórico de enfermagem para indivíduos hospitalizados com doenças infectocontagiosas / Validation of a nursing assessment for hospitalized individuals with infectious diseases

Analisar a validade dos indicadores empíricos das necessidades humanas básicas contidos em um histórico de enfermagem para indivíduos hospitalizados com doenças infectocontagiosas. Pesquisa metodológica, desenvolvida em duas etapas: análise de conteúdo e validação clínica. Na primeira etapa participaram 37 enfermeiros especialistas e, da segunda, 65 indivíduos internados nas clínicas de doenças infectocontagiosas de dois hospitais universitários. Na validação clínica, foram avaliadas a presença e a ausência dos indicadores empíricos. Na análise de conteúdo, foram eliminados 14 indicadores empíricos, considerando o critério de relevância. Quanto aos critérios de clareza e precisão, 33 indicadores empíricos tiveram suas definições operacionais reformuladas, com alfa de Cronbach de 0,967 a 0,986. Na validação clínica, foram realizados ajustes para a estruturação final do histórico de enfermagem. Concluiu-se que os indicadores empíricos do histórico de enfermagem representaram adequadamente o foco de interesse e apresentaram excelente consistência interna.

To analyze the validity of empirical indicators of basic human needs contained in a nursing assessment for individuals hospitalized with infectious diseases. Methodological study developed in two stages: content analysis and clinical validation. A total of 37 specialist nurses participated in the first stage, and in the second stage there were 65 individuals admitted to the infectious disease clinics of two university hospitals. In the clinical validation, the presence and absence of empirical indicators were evaluated. In the content analysis, 14 empirical indicators were eliminated, considering the relevance criterion. Regarding the criteria of clarity and precision, 33 empirical indicators had their operational definitions reformulated, with Cronbach's alpha from 0.967 to 0.986. In clinical validation, adjustments were made to the final structure of the nursing assessment. It was concluded that the empirical indicators of the nursing assessment adequately represented the focus of interest and showed excellent internal consistency.

Diagnóstico de enfermagem risco de recuperação cirúrgica retardada: validação de conteúdo / Nursing diagnosis risk for delayed surgical recovery: content validation

O objetivo desse estudo foi validar o conteúdo da proposta do diagnóstico de enfermagem Risco de recuperação cirúrgica retardada. Pesquisa metodológica, de validação de conteúdo por especialistas, com amostra de 34 especialistas. Utilizou-se um instrumento de coleta de dados contendo escala do tipo Likert de 1 a 5.A análise de dados foi a proporção estimada pelo teste binomial. Obteve-se10 itens da proposta diagnóstica avaliada com proporção superior ou igual a 75%. Outros sete itens: Definição; Sentimentos expressos; Histórico de retardo da cicatrização; Procedimento cirúrgico prolongado; Idade avançada; Edema e trauma no local da cirurgia; Classificação ASA elevada (American Society of Anesthesiologists); foram avaliados com proporção inferior a 75%, revisados até consenso dos especialistas. Conclui-se que o diagnóstico de enfermagem foi validado em conteúdo. Sua identificação pode possibilitar predizer a vulnerabilidade dos pacientes com Risco de recuperação cirúrgica retardada (00246), e o planejamento das intervenções perioperatórias de forma individualizada

The objective of this study was to validate the proposal ofthe nursing diagnosis Risk for delayed surgical recovery. Methodologicalresearch for content validation by specialists, with a sample of 34 specialists. A data collection instrument wasused containing a Likert-type scale of 1 to 5. The data analysis was the estimate proportion by the binomial test. Ten items were obtained from the assessed diagnosis proposal with a proportion superior or equal to 75%. Other seven items: Definition; Expressed feelings; History of healing delay; Prolonged surgical procedure; Advanced Age; Edema and trauma in the surgical site; High ASA Classification (American Society of Anesthesiologists), were assessed with a proportion lower than 75%, revised until reaching consensus among specialists. In conclusion, the nursing diagnosis was content validated. Its identification may allow predicting the vulnerability of patients with Risk for delayed surgical recovery (00246), and the planning of individualized perioperative interventions.

Review on Industrial Process Validation of Tablet Dosage Form.

Validation is one of the important steps in achieving and maintaining quality of the final product. The validation is a Fundamental segment that supports to a commitment of company towards quality assurance. It also assures that product meets its predetermined quality specification and quality characteristics. Validation of individual step of manufacturing is called as process validation. Different dosage forms have different validation protocols. Here this article concerns with the process validation of tablet dosage form which has a numerous advantages over other dosage forms. The objective is to present a review and to discuss aspects of validation in terms of pharmaceutical unit operations; that is, those individual technical operations that comprise the various steps involved in product design and evaluation.

Process validation of Amoxicillin and Clavulanic acid. Journal of Applied Pharmaceutical Science. 2012 Apr; 2(4): 82-86.

As per requirement of Export Order, validation of product should be performed as per guideline. The protocol describes the process stages, control with justification, sampling plan, acceptance criteria, summary & conclusion. During validation samples with draw according to sampling plan. The Manufacturing of Amoxicillin and Clavulanic acid are validated successfully. All the data and inprocess derived during process validation of Amoxicillin and Clavulanic acid are complied with technical manufacturing document. Hence process is validated.

Statistical assurance of process validation by analytical method development and validation for efavirenz tablets and blend.

A new simple, rapid and reliable UV Spectrophotometry method was developed and validated for the estimation of Efavirenz in blend & Tablets formulations. The method was based on simple UV estimation in cost effective manner for regular laboratory analysis. The instrument used was Perkin Elmer, UV Spectrophotometer (Lambda 25) and using 0.1 N NaoH as solvent system. Sample were analysed using UV Win Lab 5.2.0 Software and matched quartz cells 1 cm and was monitored at 302 nm. Linearity was obtained in the concentration range of 2 - 10 mg mL–1 for Efavirenz. The validation parameters, tested in accordance with the requirements of ICH guidelines, prove the suitability of this method. Spectrophotometric interferences from the Tablets excipients were not found. The results of blend uniformity and content uniformity, done on process validation batches samples.

Controle estatístico de processo aplicado ao monitoramento de envase da tintura de iodo / Statistical process control applied to used in monitoring the iodine tincture fill phase

A aplicação do controle estatístico para monitorar o desempenho da etapa de envase de formas farmacêuticas líquidas consiste em obter informações e estabelecer estratégias para a validação do processo, assim como possibilitar o gerenciamento deste a partir da percepção do comportamento das variáveis críticas do produto durante a produção. Esta etapa do processo possui como variável crítica o volume de envase. Variações neste parâmetro fora dos limites de qualidade pré-estabelecidos pela legislação refletem ineficiências durante o processo podendo ocasionar a reprovação do produto. Para demonstrar de forma objetiva o grau de segurança requerida para este tipo de processo foram utilizadas ferramentas do controle estatístico de processo (CEP) para estudar e validar o desempenho da etapa de envase da tintura de iodo fabricada pela indústria farmacêutica Lapon Química e Natural Ltda. (Limoeiro - PE, Brasil), bem como verificar a estabilidade estatística e capacidade do processo. As atividades de melhoria, através da identificação e eliminação das causas especiais de variação do processo, permitiram a redução de sua variabilidade, assegurando uma melhoria contínua da qualidade nos resultados da produção.

Statistical control is used to monitor the performance of the fill phase in the manufacture of liquid pharmaceutical forms, to obtain information and establish criteria for process validation, as well as to enable control of the process, by observing the behavior of the critical variables during production. The critical variable at this stage of the process is the filling volume. Variations in this parameter outside the established legal quality limits reflect inefficiency in the process that may result in product rejection. To demonstrate objectively the degree of security required in this type of process, statistical process control (SPC) tools were used to study and validate the performance of the fill phase in production of iodine tincture by the Pharmaceutical manufacturer Lapon Química e Natural Ltda. (Limoeiro - PE, Brazil), as well as to check the statistical stability and capacity of the process. Optimization of the process, by identifying and removing the specific causes of variation, led to a reduction in its variability, ensuring a continual improvement in the quality of production.