A qualidade pode ser considerada um fator de competitividade na atualidade para indústria farmacêutica, que trata da saúde do indivíduo. As estratégias de diferenciação e liderança de custos são analisadas para este setor, considerando as suas dimensões. A gestão estratégica da qualidade corresponde a uma visão que insere a qualidade no planejamento estratégico. Para a análise da qualidade dos medicamentos abordam-se as características da indústria farmacêutica no mundo e no Brasil, os tipos de medicamentos produzidos, as normas utilizadas pelo setor que visam a qualidade do produto, e os estágios de desenvolvimento destes. A pesquisa realizada é descritiva, visando a análise das estratégias possíveis utilizadas pelo setor no Brasil e como as dimensões da qualidade são consideradas pelas empresas. Os medicamentos produzidos no país apresentam uma estratégia de diferenciação mercadológica, utilizando as dimensões de acordo com os objetivos da empresa. A qualidade, quando existe, é baseada na abordagem da produção (dimensões de conformidade e confiabilidade) e, em alguns casos, também na abordagem baseada no produto (dimensões de desempenho, características e durabilidade). / Today, quality can be considered a factor of competitiveness for the pharmaceutical industry, which deal with the health of individuals. The strategies of differentiation and cost command are analysed for this industry which considerers its dimensions. The goal of quality administration coincides with a viewpoint of integrating quality into strategic planning. From the analysis of quality of medication comes the characteristics of the pharmaceutical industry of the world and Brazil: the types of medication produced, the standards utilized in the industry, which deals with the quality of the product, and the stages of development of the product. The research done on this subject is thorough, it deals with the analysis of possible strategies utilized by the industry in Brazil, and how the companies consider the dimensions of quality. The medications produced in this country show a strategy of market differentiation, in accordance with the objectives of the company. The quality, when present, is based on the production (dimensions of conformity and fidelity) and, in some cases, the quality can be based on the product (dimensions of development, characteristics, and durability).

O ácido lactobiônico e seus sais (lactobionatos), compostos que apresentam aplicações na área farmacêutica, foram obtidos via ação do complexo enzimático glicose-frutose oxidorredutase (GFOR)/gliconolactonase (GL) - presente no periplasma de células da bactéria Zymomonas mobilis - imobilizado em alginato de cálcio. Nas reações catalisadas por este sistema enzimático, o pH do meio deve ser controlado em valores ligeiramente ácidos. Para este fim, foram empregados NaOH, KOH ou Ca(OH)2 e, como consequência, os respectivos sais foram formados. O estudo da cinética de formação dos lactobionatos de sódio, potássio e cálcio e do próprio ácido lactobiônico foi seguido das etapas de purificação, caracterização e avaliação da estabilidade físico-química, visando à potencial utilização destes compostos na área farmacêutica. Em ensaios de bioprodução dos lactobionatos de sódio, potássio e cálcio, foram obtidos rendimentos de 74, 77 e 84%, respectivamente. Em bateladas sucessivas de bioconversão, totalizando 96 h de uso do biocatalisador, rendimentos de 80 e 56 % em lactobionatos de cálcio e de potássio foram atingidos. Na etapa de purificação dos sais, foram alcançados teores de pureza de aproximadamente 95%, sendo então procedida a caracterização dos compostos por cromatografia líquida de alta eficiência, espectrometria de massas e RMN de 13C. Nos estudos de estabilidade acelerada, de longa duração e degradação forçada, os lactobionatos de sódio, potássio e cálcio obtidos nos ensaios de bioconversão conduzidos em maior volume reacional, foram inicialmente purificados e, então, comparados frente ao ácido lactobiônico, obtido por troca iônica a partir do lactobionato de sódio, e com o ácido lactobiônico comercial (Sigma-Aldrich). Nos testes de estabilidade acelerada e de longa duração, foi constatada a estabilidade de todos os compostos por até seis meses quando expostos a 30 e 40oC e 75% de umidade relativa. Por outro lado, a presença da lactobionolactona foi identificada nas amostras dos compostos na forma ácida. Com relação aos testes de degradação forçada, os lactobionatos de sódio, potássio, e cálcio e o ácido lactobiônico se mostraram estáveis frente à exposição a soluções ácidas e alcalinas e às temperaturas avaliadas. Contudo, observou-se degradação no tratamento com solução oxidativa, com cinética de degradação de ordem zero para os sais e de segunda ordem para o ácido lactobiônico. Elevadas concentrações de produtos - lactobionatos de sódio, potássio e cálcio - foram atingidas com a utilização do sistema GFOR/GL imobilizado em alginato de cálcio. Considerando o conjunto de informações obtido, quanto à caracterização físico-química dos compostos produzidos, foi demonstrada a estabilidade frente aos diferentes parâmetros avaliados atendendo aos requisitos mínimos legais para sua aplicação na área farmacêutica. / Coordenação de Aperfeiçoamento de Pessoal de Nível Superior, CAPES. / Lactobionic acid and its salts (lactobionate) are substances that have several applications in pharmaceutical area. These products were obtained by enzymatic complex glucose-fructose-oxidoreductase (GFOR)/gluconolactonase (GL) present in the periplasm of Zymomonas mobilis cells that were immobilized in calcium alginate. In the reactions catalyzed by this enzyme system, the medium pH must be controlled at slightly acid values. For this purpose, NaOH, KOH, or Ca(OH)2 were used and as a result the respective salts were formed. The kinetic study on the formation of sodium, potassium and calcium lactobionate and lactobionic acid itself was followed by the steps of purification, characterization and evaluation of the physicochemical stability, aiming the potential use of these compounds in the pharmaceutical area. In the assays for the bioproduction of sodium, potassium or calcium lactobionates, yields of 74, 77 and 84% were obtained, respectively. In repeated bioconversion batches, totalizing 96 hours of use of the biocatalyst, yields of 80 and 56% were attained for calcium and potassium lactobionate. In the salts purification step, purity levels of approximately 95% were achieved, and subsequently these compounds were characterized by high performance liquid chromatography, mass spectrometry, and C13 NMR. In the studies of accelerated, long term and forced degradation stability, the production of sodium, potassium and calcium lactobionate was carried out at higher reaction volume. The products were purified and then evaluated together with lactobionic acid that was obtained by ion-exchange from sodium lactobionate, and with a commercial lactobionic acid (Sigma-Aldrich). In the accelerated and long term stability tests, it was demonstrated the stability of all compounds when exposed to 30 and 40oC and of 75%of relative humidity for up to six months. On the other hand, the presence of lactobionolactone was identified in samples of compounds in the acid form. With respect to the forced degradation tests, sodium, potassium and calcium lactobionates and lactobionic acid have shown to be stable after exposing to both acidic and alkaline solutions and the temperatures evaluated. However, degradation was observed in the treatment with oxidative solution, with a zero-order degradation kinetics for the salts forms and second-order for lactobionic acid. High concentrations of products - sodium, potassium and calcium lactobionate - were achieved by using the Ca-alginate immobilized GFOR/GL complex. Considering the set of information obtained in regarding to physicochemical characterization, it was demonstrated the high stability of these compounds in front of different parameters evaluated, endorsing the legal minimum requirements for their application in the pharmaceutical area.

The levels of service quality at International Healthcare Distributors (IHD) have been determined. Service quality in organisations require a strong emphasis on customer service and service delivery processes. The main area of this study focuses on the need for appropriate levels and criteria of service quality that will satisfy customers of pharmaceutical distributors. Various determinants affecting service quality levels have been discussed. The nature of service quality has been outlined and customer expectation standards have been determined. Customer satisfaction versus service quality has been discussed and the consumers’ perceptions towards service quality have been identified. Obstacles to attaining service quality have been described and potential causes of service quality shortfalls have been defined. Various surveys were studied to determine the implementation of service quality dimensions in a variety of disciplines. A sample was taken from the IHD customer base and a questionnaire was designed and distributed to the customers. The questionnaire examined five dimensions, tangibility, reliability, responsiveness, assurance and empathy. There was a hundred percent response rate. The results indicated that the tangibility dimension was highest in terms of customer agreement and reliability the lowest. The results of the questionnaire have proven that two of the hypotheses are negative and one positive. Concluding remarks and recommendations were highlighted and it is evident that IHD needs to improve its level of service quality in order to meet their customer requirements.

University of Macau / Institute of Chinese Medical Sciences

This diploma thesis deals with the selected institutes and specifics of patent law in pharmaceutical industry. The aim is to analyze and critically evaluate these institutes and specifics. Although the topic requires a certain overlap into different scientific fields, the thesis emphasizes on the legal aspects of these institutes. The thesis is based on the Czech legislation; however, many chapters require an insight into the European or/and international legal context. Furthermore, the case law of a foreign court and the European Patent Office is also presented. To begin with, the thesis deals with definitions of the key terms of a patent law and presents a brief overview of the legislation on the national level as well as internationally. In the next chapter the area of pharmaceutical industry is introduced, more specifically its historical background and a specific terminology used in such area. The thesis contains a chapter dealing with the area of biotechnology as well. In the crucial part of this thesis, firstly general requirements for patentability of inventions are defined and the question of patentability of biotechnological inventions is evaluated. The attitude towards patentability of genetic modifications and cloning is evaluated more closely. Furthermore the requirements of the gene's...

M.Phil. (Information Management) / The purpose of this study was to establish what the current situation is within the South African pharmaceuticals industry's competitive intelligence (CI) capacity. For a developing country such as South Africa, its political history and newly acquired democracy clearly make it vulnerable to the competitiveness of globalisation. South Africa faces a massive challenge to implement quality social and economic policies to redress the wrongs of the past. In so doing, it continues to disrupt natural market forces through legislation and policies. It has set a goal of optimal growth by 2018 for the pharmaceutical industry. Despite government s promotion of research and the funding of certain aspects of the industry, to date the strategy seems to have failed. The question can therefore be asked whether a legal and ethical business tool such as CI assist in the industry s defence against competitive markets and whether senior management can make use of CI s capacity to help with strategic planning, thereby enhancing decision-making. The findings of the study confirmed that CI activity takes place in the pharmaceutical industry. The study is mainly descriptive. A questionnaire survey methodology was used. Questionnaires were administered electronically to senior managers in the industry. The majority of the respondents were of the opinion that a culture of information sharing and an environment of collaboration on competitive issues existed in their companies. Furthermore, they endorsed the fact that CI generates profit. Respondents confirmed that CI is used on a continuous basis in strategic decision-making and that company strategies are being used to manage competitors.

There is a great need for a pharmaceutical manufacturer to provide its customers with the right product at the right time, place and price and also to deliver the product in the right quantity and quality. Should pharmaceutical customers not receive their orders on time from the pharmaceutical manufacturer, the customers might face out-of-stock situations. As a result, the patients or customers might turn to an alternative product from a different pharmaceutical manufacturer, which has the required stock readily available. This could lead to loss in sales and even death amongst its customers. The main objective of this study was to determine the key factors that form part of the demand and operations planning strategies to ensure that these factors are in place to effectively manage and execute the supply chain and logistics processes to reduce possible out-of-stock situations amongst its customers. As a starting point to the study, an analysis was performed based on the review of relevant research and literature from various text books, journals, publications, as well as internet sources. The literature study covered various aspects such as demand planning, production planning, the use of different demand and operations planning strategies, as well as the importance of continuous internal and external customer service levels to ensure that customer orders are delivered on time. The analysis of the literature review was used to establish a theoretical basis for the design and structure of the questionnaire that was used as a research instrument in this study. A survey was conducted amongst the employees that are responsible for executing the supply chain and logistics processes within Aspen Pharmacare. These employees resided within the three main departments of the pharmaceutical manufacturer, namely, the Demand and Operations Planning, Production and Packing, as well as the Warehouse and Distribution departments. Each question posed in the questionnaire related to the role of each employee within these departments that are responsible for the logistics processes within Aspen Pharmacare. The empirical results from the study indicated that the respondents were in support that specific key factors are important for a pharmaceutical manufacturer to manage incoming customer orders efficiently and effectively to reduce possible out-of-stock situations amongst its end customers. However, the respondents also highlighted that there were a number of obstacles preventing them from implementing the key factors that are required to manage incoming customer orders more efficiently within the pharmaceutical manufacturer. Some of these obstacles include: the lack of pro- activeness; lack of accountability; and the lack of constant communication between the employees from the three main departments. Furthermore, incomplete hand-over information during shift changes amongst the employees of the Production and Packing department created unnecessary down-time. Also, the employees from the Warehouse and Distribution department were not informed timeously when changes to the production schedule were made. These obstacles will have a negative impact on the ultimate customer delivery dates and need to be addressed. The empirical results highlighted some recommendations to assist pharmaceutical manufacturing companies to more effectively and efficiently manage their incoming customer orders to reduce or eliminate any possible out-of-stock situations amongst its end customers. Some recommendations include: improved communication between the three main departments; to react immediately to out-of-stock products; and to ensure that internal and external customer service levels are adhered to at all times. The implementation of the recommendations based on the empirical findings of the study will assist the pharmaceutical manufacturing company to achieve excellence and to become a world-class supplier of generic pharmaceutical products. In this way, all incoming customer orders can be fulfilled on time.

Pharmacists as members of health care teams, have a central role to play with respect to medication. The pharmaceutical care and cognitive services which pharmacists are able to provide can help prevent, ameliorate or correct medication-related problems. There are however many barriers to the provision of these services and one of the barriers commonly cited by pharmacists is the lack of remuneration for their expert services. The aim of this study is to ascertain if patients in South Africa are willing to pay for pharmacist-provided services which may reduce medication related problems, and thereby determine the perceived value of the pharmacist-provided services, by patients. The study will also seek to determine factors that influence willingness to pay (WTP), including financial status, gender, race, age and level of education. In addition the perceived value of the pharmacist‘s role in patient care, by third party payers (SA Medical Aid providers) and their WTP for pharmacist-provided services (such as DSM) on behalf of patients through their monthly premiums will also be investigated. The study was conducted as a two-phase process: the first phase focused on the opinions of patients and the second phase on the medical aid companies. In phase-1 a convenience sample of 500 patients was recruited by fifty community pharmacies distributed throughout the nine South African provinces. Data collection, consisting of telephonic administration of the questionnaires, was conducted and the survey responses were captured on a Microsoft Excel® spreadsheet. All the captured information was analyzed using descriptive statistics, box and whisker plots, analysis of variance (ANOVA) and regression analysis. In phase-2, medical aid schemes that are registered with the Council of Medical Schemes (CMSs) of South Africa were included in this research. A fifteen point questionnaire was completed electronically via e-mail by willing medical aid participants. Data was analyzed using descriptive statistics only. Only 233 or 88.6 percent, of the 263 participating respondents, were willing to pay at least one rand towards pharmacist-provided services. On average respondents were willing to pay R126.76 as out-of-pocket expenses. Respondents‘ WTP increased as the risk associated with medication-related problems was reduced due to pharmaceutical care intervention. Of the 263 respondents who took part in this research, fifty percent were willing to pay at least R100 for a risk reduction of 30 percent, R120 for a 60 percent reduction and approximately R150 for a greater than 90 percent risk reduction. It was also found that the respondents‘ willingness to pay was influenced by their age, earnings, racial grouping, employment status, medical aid status and their level of satisfaction with pharmacist-provided care services. Of the thirty-one open medical aid schemes only eight (25.8 percent) participated in the study. Findings indicate that all the participating medical aid respondents were unwilling to pay for pharmacist-provided care services, although they perceived pharmacists as very influential healthcare providers and as having a significant role to play in reducing medication-related problems. In conclusion it was found that majority of participants were willing to pay for pharmacist-provided services directed towards reducing risks associated with medication-related problems. Until pharmacists are able to prove pharmaceutical care‘s utility and cost-effectiveness to third-party payers, pharmacists must look to the patient for reimbursement.

This investigation attempts to examine the influences of validation on pharmaceutical processes especially at a new manufacturing facility that has to meet international requirements, and fulfil a cost effective business strategy. At Aspen Pharmacare, a pharmaceutical organisation, there are two manufacturing facilities situated adjacent to each other, one new and one old. The new facility creates ideal opportunities to supply products to local and international markets. The investigation compares legal requirements from local and international regulatory authorities. Validation and qualification practices as well as the problems encountered during the different phases are discussed. Particular attention is given to the validation approach at the new Aspen facility. Problems and proposed solutions relating to the design review, installation, operational, and performance qualification are discussed. Validation of analytical methods for cleaning analysis, cleaning validation of equipment, and optimisation of some tablet manufacturing processes are described. Statistical evaluations of analytical results are included to find the optimum conditions for integrating new personnel with new processes and equipment. A business model reviews the cost of non-conformances of the enalapril maleate 10 mg tablets manufactured at the two manufacturing facilities. Finally the dissertation proves that validation is not only a regulatory requirement but that it also provides benefits such as adding value to the business, and ultimately reducing the cost of medicines.

The purpose of this study was to find differences, in degree of "skepticism" about the manufacturing and marketing of drugs, among groups of medical doctors categorized according to training and experience, "Skepticism" was measured by a questionnaire prepared by the Department of Pharmacology with the collaboration of the Department of Psychology, University of British Columbia. The questionnaire was composed of eighteen statements representing issues about the manufacturing and marketing of drugs; "skepticism" was measured by degree of agreement or disagreement with each statement, expressed on a four-point response scale accompanying each statement. Eleven different ways of classifying doctors according to training and experience were employed, and each of these eleven involved a plurality of groups. Altogether 906 groups were considered. The "Skepticism" questionnaire together with a "Personal Data" section to supply data for classifying according to training and experience were sent to the 2413 B.C. doctors registered by the B.C. College of Physicians and Surgeons. Of the 2413 sent, 1193 were returned. Chi-square comparisons were made in order to determine which groups of doctors were relatively "skeptical" or "naive" according to each of the eighteen questionnaire statements. The great majority of comparisons failed to show differences significant at the .05 level. Comparisons which were significant showed instances where groups of respondents were relatively "skeptical" or "naive"; these were the findings it was the purpose of this study to obtain. These findings were discussed with reference to the particular groups of doctors, and questionnaire statements involved. / Arts, Faculty of / Psychology, Department of / Graduate