Product quality and compliance in the pharmaceutical industry

This thesis aims to highlight the importance of a Product Quality & Compliance department in a Pharmaceutical Industry, on the good performance of company's activities and the achievement of their goals and mission. Despite the wide activities performed by this Department, the purpose of this work will be completed by describing only some of their reponsibilities. The tasks described are specifically the ones I have been performing throughout my professional experience at Bluepharma - Pharmaceutical Industry, SA, initiated in June 2012 in the Quality Assurance Department until today in the currently named Product Quality & Compliance department. This thesis is structured into 4 parts. The first chapter is an introduction to this thesis, and includes its context and objectives, followed by a brief overview of the state-of-the art in the pharmaceutical industry, including the market environment, the regulatory environment and quality requirements. A small presentation of the company and the department where were and still are developed my professional activity is also made in this chapter. In the following chapter are described the main tasks performed, the complementary activities and key skills acquired throughout this professional experience. A discussion and conclusion is presented at the end, including an analysis of the reported activities, main difficulties encountered its role and importance in the company performance as well as the skills acquired during this work experience.

Essays in Market Design

In this dissertation, I study three problems in market design: the allocation of resources to schools using deferred acceptance algorithms, the demand reduction of employees on centralized labor markets, and the alleviation of traffic congestion. I show how institutional and behavioral considerations specific to each problem can alleviate several practical limitations faced by current solutions. For the case of traffic congestion, I show experimentally that the proposed solution is effective. In Chapter 1, I investigate how school districts could assign resources to schools when it is desirable to provide stable assignments. An assignment is stable if there is no student currently assigned to a school that would prefer to be assigned to a different school that would admit him if it had the resources. Current assignment algorithms assume resources are fixed. I show how simple modifications to these algorithms produce stable allocations of resources and students to schools. In Chapter 2, I show how the negotiation of salaries within centralized labor markets using deferred acceptance algorithms eliminates the incentives of the hiring firms to strategically reduce their demand. It is well-known that it is impossible to eliminate these incentives for the hiring firms in markets without negotiation of salaries. Chapter 3 investigates how to achieve an efficient distribution of traffic congestion on a road network. Traffic congestion is the product of an externality: drivers do not consider the cost they impose on other drivers by entering a road. In theory, Pigouvian prices would solve the problem. In practice, however, these prices face two important limitations: i) the information required to calculate these prices is unavailable to policy makers and ii) these prices would effectively be new taxes that would transfer resources from the public to the government. I show how to construct congestion prices that retrieve the required information from the drivers and do not transfer resources to the government. I circumvent the limitations of Pigouvian prices by assuming that individuals make some mistakes when selecting routes and have a tendency towards truth-telling. Both assumptions are very robust observations in experimental economics.

Industry Linkages and Audit Firms' Industry Portfolio Choice: Evidence from Product Language

Audit firms are organized along industry lines and industry specialization is a prominent feature of the audit market. Yet, we know little about how audit firms make their industry portfolio decisions, i.e., how audit firms decide which set of industries to specialize in. In this study, I examine how the linkages between industries in the product space affect audit firms’ industry portfolio choice. Using text-based product space measures to capture these industry linkages, I find that both Big 4 and small audit firms tend to specialize in industry-pairs that 1) are close to each other in the product space (i.e., have more similar product language) and 2) have a greater number of “between-industries” in the product space (i.e., have a greater number of industries with product language that is similar to both industries in the pair). Consistent with the basic tradeoff between specialization and coordination, these results suggest that specializing in industries that have more similar product language and more linkages to other industries in the product space allow audit firms greater flexibility to transfer industry-specific expertise across industries as well as greater mobility in the product space, hence enhancing its competitive advantage. Additional analysis using the collapse of Arthur Andersen as an exogenous supply shock in the audit market finds consistent results. Taken together, the findings suggest that industry linkages in the product space play an important role in shaping the audit market structure.

Challenges and Opportunities in Transforming Laser System Industry to Deliver Integrated Product and Service Offers

Part 4: Transition Towards Product-Service Systems

CHARACTERIZING AND IMPROVING PRODUCTION OF FERMENTABLE SUGARS AND CO-PRODUCTS FROM A FOREST PRODUCT INDUSTRY WASTEWATER STREAM

Hardboard processing wastewater was evaluated as a feedstock in a bio refinery co-located with the hardboard facility for the production of fuel grade ethanol. A thorough characterization was conducted on the wastewater and the composition changes of which during the process in the bio refinery were tracked. It was determined that the wastewater had a low solid content (1.4%), and hemicellulose was the main component in the solid, accounting for up to 70%. Acid pretreatment alone can hydrolyze the majority of the hemicellulose as well as oligomers, and over 50% of the monomer sugars generated were xylose. The percentage of lignin remained in the liquid increased after acid pretreatment. The characterization results showed that hardboard processing wastewater is a feasible feedstock for the production of ethanol. The optimum conditions to hydrolyze hemicellulose into fermentable sugars were evaluated with a two-stage experiment, which includes acid pretreatment and enzymatic hydrolysis. The experimental data were fitted into second order regression models and Response Surface Methodology (RSM) was employed. The results of the experiment showed that for this type of feedstock enzymatic hydrolysis is not that necessary. In order to reach a comparatively high total sugar concentration (over 45g/l) and low furfural concentration (less than 0.5g/l), the optimum conditions were reached when acid concentration was between 1.41 to 1.81%, and reaction time was 48 to 76 minutes. The two products produced from the bio refinery were compared with traditional products, petroleum gasoline and traditional potassium acetate, in the perspective of sustainability, with greenhouse gas (GHG) emission as an indicator. Three allocation methods, system expansion, mass allocation and market value allocation methods were employed in this assessment. It was determined that the life cycle GHG emissions of ethanol were -27.1, 20.8 and 16 g CO2 eq/MJ, respectively, in the three allocation methods, whereas that of petroleum gasoline is 90 g CO2 eq/MJ. The life cycle GHG emissions of potassium acetate in mass allocation and market value allocation method were 555.7 and 716.0 g CO2 eq/kg, whereas that of traditional potassium acetate is 1020 g CO2/kg.

Product/Brand co-creation methodology crossing marketing, design thinking, creativity and management: ideas(r)evolution

This thesis introduce a new innovation methodology called IDEAS(R)EVOLUTION that was developed according to an on-going experimental research project started in 2007. This new approach to innovation has initial based on Design thinking for innovation theory and practice. The concept of design thinking for innovation has received much attention in recent years. This innovation approach has climbed from the design and designers knowledge field towards other knowledge areas, mainly business management and marketing. Human centered approach, radical collaboration, creativity and breakthrough thinking are the main founding principles of Design thinking that were adapted by those knowledge areas due to their assertively and fitness to the business context and market complexity evolution. Also Open innovation, User-centered innovation and later on Living Labs models emerge as answers to the market and consumers pressure and desire for new products, new services or new business models. Innovation became the principal business management focus and strategic orientation. All this changes had an impact also in the marketing theory. It is possible now to have better strategies, communications plans and continuous dialogue systems with the target audience, incorporating their insights and promoting them to the main dissemination ambassadors of our innovations in the market. Drawing upon data from five case studies, the empirical findings in this dissertation suggest that companies need to shift from Design thinking for innovation approach to an holistic, multidimensional and integrated innovation system. The innovation context it is complex, companies need deeper systems then the success formulas that “commercial “Design thinking for innovation “preaches”. They need to learn how to change their organization culture, how to empower their workforce and collaborators, how to incorporate external stakeholders in their innovation processes, hoe to measure and create key performance indicators throughout the innovation process to give them better decision making data, how to integrate meaning and purpose in their innovation philosophy. Finally they need to understand that the strategic innovation effort it is not a “one shot” story it is about creating a continuous flow of interaction and dialogue with their clients within a “value creation chain“ mindset; RESUMO: Metodologia de co-criação de um produto/marca cruzando Marketing, Design Thinking, Criativity and Management - IDEAS(R)EVOLUTION. Esta dissertação apresenta uma nova metodologia de inovação chamada IDEAS(R)EVOLUTION, que foi desenvolvida segundo um projecto de investigação experimental contínuo que teve o seu início em 2007. Esta nova abordagem baseou-se, inicialmente, na teoria e na práctica do Design thinking para a inovação. Actualmente o conceito do Design Thinking para a inovação “saiu” do dominio da area de conhecimento do Design e dos Designers, tendo despertado muito interesse noutras áreas como a Gestão e o Marketing. Uma abordagem centrada na Pessoa, a colaboração radical, a criatividade e o pensamento disruptivo são principios fundadores do movimento do Design thinking que têm sido adaptados por essas novas áreas de conhecimento devido assertividade e adaptabilidade ao contexto dos negócios e à evolução e complexidade do Mercado. Também os modelos de Inovação Aberta, a inovação centrada no utilizador e mais tarde os Living Labs, emergem como possiveis soluções para o Mercado e para a pressão e desejo dos consumidores para novos productos, serviços ou modelos de negócio. A inovação passou a ser o principal foco e orientação estratégica na Gestão. Todas estas mudanças também tiveram impacto na teoria do Marketing. Hoje é possivel criar melhores estratégias, planos de comunicação e sistemas continuos de diálogo com o público alvo, incorporando os seus insights e promovendo os consumidores como embaixadores na disseminação da inovação das empresas no Mercado Os resultados empiricos desta tese, construídos com a informação obtida nos cinco casos realizados, sugerem que as empresas precisam de se re-orientar do paradigma do Design thinking para a inovação, para um sistema de inovação mais holistico, multidimensional e integrado. O contexto da Inovação é complexo, por isso as empresas precisam de sistemas mais profundos e não apenas de “fórmulas comerciais” como o Design thinking para a inovação advoga. As Empresas precisam de aprender como mudar a sua cultura organizacional, como capacitar sua força de trabalho e colaboradores, como incorporar os públicos externos no processo de inovação, como medir o processo de inovação criando indicadores chave de performance e obter dados para um tomada de decisão mais informada, como integrar significado e propósito na sua filosofia de inovação. Por fim, precisam de perceber que uma estratégia de inovação não passa por ter “sucesso uma vez”, mas sim por criar um fluxo contínuo de interação e diálogo com os seus clientes com uma mentalidade de “cadeia de criação de valor”

Conceptualization of an Electric Compact SUV for the American and Italian Market using the IDeS Method

Electric cars are increasingly popular due to a transition of mobility towards more sustainable forms. From an increasingly green and pollution reduction perspective, there are more and more incentives that encourage customers to invest in electric cars. Using the Industrial Design and Structure (IDeS) research method, this project has the aim to design a new electric compact SUV suitable for all people who live in the city, and for people who move outside urban areas. In order to achieve the goal of developing a new car in the industrial automotive environment, the compact SUV segment was chosen because it is a vehicle very requested by the costumers and it is successful in the market due to its versatility. IDeS is a combination of innovative and advanced systematic approaches used to set up a new industrial project. The IDeS methodology is sequentially composed of Quality Function Deployment (QFD), Benchmarking (BM), Top-Flop analysis (TFA), Stylistic Design Engineering (SDE), Design for X, Prototyping, Testing, Budgeting, and Planning. The work is based on a series of steps and the sequence of these must be meticulously scheduled, imposing deadlines along the work. Starting from an analysis of the market and competitors, the study of the best and worst existing parameters in the competitor’s market is done, arriving at the idea of a better product in terms of numbers and innovation. After identifying the characteristics that the new car should have, the other step is the styling part, with the definition of the style and the design of the machine on a 3D CAD. Finally, it switches to the prototyping and testing phase to see if the product is able to work. Ultimately, intending to place the car on the market, it is essential to estimate the necessary budget for a possible investment in this project.

Antioxidant And Antiproliferative Activities Of Methanolic Extract From A Neglected Agricultural Product: Corn Cobs.

Neglected agricultural products (NAPs) are defined as discarded material in agricultural production. Corn cobs are a major waste of agriculture maize. Here, a methanolic extract from corn cobs (MEC) was obtained. MEC contains phenolic compounds, protein, carbohydrates (1.4:0.001:0.001). We evaluated the in vitro and in vivo antioxidant potential of MEC. Furthermore, its antiproliferative property against tumor cells was assessed through MTT assays and proteins related to apoptosis in tumor cells were examined by western blot. MEC showed no hydroxyl radical scavenger capacity, but it showed antioxidant activity in Total Antioxidant Capacity and DPPH scavenger ability assays. MEC showed higher Reducing Power than ascorbic acid and exhibited high Superoxide Scavenging activity. In tumor cell culture, MEC increased catalase, metallothionein and superoxide dismutase expression in accordance with the antioxidant tests. In vivo antioxidant test, MEC restored SOD and CAT, decreased malondialdehyde activities and showed high Trolox Equivalent Antioxidant Capacity in animals treated with CCl4. Furthermore, MEC decreased HeLa cells viability by apoptosis due an increase of Bax/Bcl-2 ratio, caspase 3 active. Protein kinase C expression increased was also detected in treated tumor cells. Thus, our findings pointed out the biotechnological potential of corn cobs as a source of molecules with pharmacological activity.

Preference Mapping Of Dulce De Leche Commercialized In Brazilian Markets.

Dulce de leche samples available in the Brazilian market were submitted to sensory profiling by quantitative descriptive analysis and acceptance test, as well sensory evaluation using the just-about-right scale and purchase intent. External preference mapping and the ideal sensory characteristics of dulce de leche were determined. The results were also evaluated by principal component analysis, hierarchical cluster analysis, partial least squares regression, artificial neural networks, and logistic regression. Overall, significant product acceptance was related to intermediate scores of the sensory attributes in the descriptive test, and this trend was observed even after consumer segmentation. The results obtained by sensometric techniques showed that optimizing an ideal dulce de leche from the sensory standpoint is a multidimensional process, with necessary adjustments on the appearance, aroma, taste, and texture attributes of the product for better consumer acceptance and purchase. The optimum dulce de leche was characterized by high scores for the attributes sweet taste, caramel taste, brightness, color, and caramel aroma in accordance with the preference mapping findings. In industrial terms, this means changing the parameters used in the thermal treatment and quantitative changes in the ingredients used in formulations.

Proposta de mecanismo de lavagem em equipamentos de beneficiamento de tomate de mesa

The cleanness level in fresh market tomatoes cleaning equipment is essential for consumer acceptance and conservation of product quality. However, the washing process in cleaning current equipments demands an excessive volume of water, leading to serious economic and environmental concerns. The objective of this work was to contribute with technical information for the washing system optimization. The conventional washing system currently used in cleaning equipment, which consists of perforated PVC pipes, was compared with a proposed system which uses commercial sprays. Characteristic curves (flow rate versus pressure) for both systems were determined in lab conditions and the respective water consumptions were compared. The results confirmed the excess of water consumption in the conventional washing systems, and the proposed system proved that is possible to reduce it, and the use of sprays allowed the rational use of the water.

Avaliação de índices de firmeza para abacaxi minimamente processado em fatias tratadas com soluções de sais de cálcio

Fresh-cut sliced fruits and vegetables are ready to eat immediately and their sensorial characteristics should be similar to fresh product. Although most of the studies in this area are focused on vegetables, there is a great market potential for fresh-cut sliced fruits, mainly for those which exhibit some commercialization or preparation difficulties such as pineapple. The objective of this work was to evaluate the effect of 1% and 3% concentrations of calcium salts (chloride, sulphate and lactate) on pH, total soluble solids and firmness values of minimally processed pineapple slices. Two types of indenters and three firmness indexes were investigated aiming to identify the best index. Results showed that calcium sulphate 3% kept average firmness index up to 44.45% higher than the index value of the control. Even though both indenters exhibited similar variability the cylindrical one was able to point out more differences between control and treatments than the cylindrical borer indenter.

Hidrocarbonetos aromáticos policíclicos em margarina, creme vegetal e maionese

Polycyclic aromatic hydrocarbons (PAHs) are a group of compounds that have been the subject of much concern due to their toxic potential. In this study, margarine?s, vegetable cream and mayonnaise available on the Brazilian market were analyzed for pyrene, chrysene, benzo(a)pyrene, benzo(b)fluoranthene and dibenzo(a,h)anthracene. The analytical methodology involved liquid-liquid extraction, clean-up on silica gel column and determination by high performance liquid chromatography using fluorescence detector. Variable levels of contamination were found within differents brands of the same product and within differents batches of the same brand. The total PAH content was in the range of 4.1 to 7.1mug/kg in vegetable cream, 1.7 to 3.9mug/kg in margarine and 1.0 to 21.7mug/kg in mayonnaise. In general the products which according to the label contain corn oil showed the highest levels of contamination. Based on these results and on the importance of fat, oils and derived products for the intake of PAHs, it is recommended that producers of margarine, vegetable creams and mayonnaise start to control the contamination of the vegetable oils used in the elaboration of these products, in order to reduce the exposure of consumers to excessive amounts of potentially carcinogenic compounds.

Nuclear and mitochondrial DNA markers in traceability of retail beef samples

Several characteristics are important in a traceability system of animal products, such as age at slaughter, breed composition, besides information of the productive chain. In general, the certification agent records information about the animals and the system which it came from, although cannot guarantee that the slaughtering, meat processing and distribution are error proof. Besides, there is a differential price, at least at the international market, based on sex and breed composition of the animals. Genetic markers allow identification of characteristics controlled in the beef cattle traceability program, as sex and breed composition, in order to correctly identify and appraise the final product for the consumer. The hypothesis of this study was that the majority beef samples retailed in the local market originate from female with a great participation of zebu breeds. Therefore, the objective of this work was to characterize retail beef samples with DNA markers that identify cattle sex and breed composition. Within 10 beef shops localized in Pirassununga, SP, Brazil, 61 samples were collected, all were genotyped as harboring Bos taurus mitochondrial DNA and 18 were positive for the Y chromosome amplification (male). For the marker sat1711b-Msp I the frequency of the allele A was 0.278 and for the marker Lhr-Hha I the frequency of the allele T was 0.417. The results of sat1711b-Msp I and Lhr-Hha I allelic frequencies are suggestive that the proportion of indicus genome compared with the taurine genome in the market meat is smaller than the observed in the Nellore breed. The procedure described in this study identified sex and subspecies characteristics of beef meat samples, with potential application in meat products certification in special as an auxiliary tool in beef cattle traceability programs.

O arroz no varejo e os fatores que influenciam o dispêndio das famílias consumidoras

Apesar da idéia consagrada de que arroz é uma commodity e, portanto, pouco passível de diferenciação, há um grande número de produtos, com variação de tipo, classe, padrão, embalagem, marca etc. Observa-se significativa variabilidade nos preços, tanto entre diferentes marcas, fabricantes, lojas, como também para um mesmo produto, em um curto intervalo de tempo. Diante dessas constatações, questiona-se qual o efeito da estratégia de compra de arroz por parte dos consumidores sobre seus dispêndios. Este trabalho utiliza modelos matemáticos para simular o processo de decisão de compra dos consumidores com diferentes perfis de preferência, diante dos produtos nas gôndolas dos supermercados em uma cidade no estado do Rio Grande do Sul e outra em São Paulo.

Storage stability of snacks with reduced saturated and trans fatty acids contents

A gordura vegetal parcialmente hidrogenada tem sido utilizada na aromatização de snacks. Entretanto, o risco à saúde ocasionado pelo elevado consumo de ácidos graxos saturados e trans (AGT) vem estimulando o desenvolvimento de abordagens alternativas a essa gordura. Substituímos a gordura vegetal parcialmente hidrogenada (F) por óleo de canola (O) na aromatização de snacks. Snacks com diferentes níveis de O foram produzidos, embalados e armazenados em temperatura ambiente durante vinte semanas. Monitoramos o perfil de ácidos graxos, o teor de substâncias reativas ao TBA (TBARS), a força de cisalhamento e a aceitabilidade sensorial. A substituição total reduziu o teor de ácidos graxos saturados em 72,5 por cento, em comparação aos snacks comerciais. Os snacks eram inicialmente isentos de AGT, porém, após 8 semanas, esses compostos surgiram, havendo aumento gradual durante o período de armazenamento. Entretanto, estes níveis mantiveram-se inferiores aos observados em snacks comercializados. Também foram observados baixos teores de TBARS e estabilidade da força de cisalhamento. Snacks aromatizados com F ou O foram igualmente bem aceitos durante as vinte semanas de armazenamento. É possível desenvolver snacks com teores reduzidos de ácidos graxos saturados e trans, estáveis durante o armazenamento, mantendo a elevada aceitabilidade sensorial típica deste tipo de produto