Good Practices In The Third Party Audits Of The Systems Of Quality Management According To TÜV Cert Requirements

The third party audit of the systems of quality management may be performed by quality auditors, who represent a certain certifying body, fulfilling the rules of good practice provided therein. Being the interface between the certifying body and audited clients / organisations in different fields of activity, the auditors are selected and trained permanently with a view to improve their performance and implicitly the image of certifying body. The objectives of the article are to present the rules applied within international certifying bodies, from the perspective of that involved directly for almost ten years in this activity, simultaneously with university activity. With respect to the manner of collecting the information, the article relies on the experience of the author in the capacity of third party auditor, competent in the following fields: education, research, trade, tourism, services. The practical issues emphasized in the article refer to the rules appropriated by third party auditors within famous international certifying bodies TÜV Rheinland and respectively TÜV Austria, where the author of the article began and respectively carries out his activity currently. Their image and fame is due to the rules of good practice, fulfilled in these certifying bodies for over 130 years. The article presents the stages of theoretical and practical formation of an auditor, the objectives to be reached on each stage of preparation, what his activity involves within the certifying body, the collaboration with the other auditors, permanent training and experience exchanges during the international conferences organised by certifying bodies, practice of audit, possibility of maintaining as auditor and advancing as chief auditor, the status of third party auditor.quality management, audit, certifying body, standard, training

Good Practices Preceding the Implementation of the System of Management of Environment, on Small and Medium Enterprises

The current and future economic context compel to ample reconsiderations related to the volume and content of the demarches carried out by organisations, in order to face the competition sharper and sharper and the more and more numerous rigors, among which the issue of environment is more than imperative. The good practices in environment management become more and more necessary and, fortunately, are supplied more and more often by organisations in SMEs category, which encounter highly valuable solutions in this context charged with convictions. This work features an exemplary performance of a small organisation that managed to settle an informal system of management of environment, built up with much rigour, involvement, respect for society and environment. The objectives of authors consist in offering good practices to business environment, from SMEs category, means of approaching in the analysis of environment practices and emphasizing the imperatives in this area of action, for organisations. The method of research included the consulting of some lists of specialised works, documentary study in the sites of the organisations from SMEs category and of the organisations in the field, adopting some established models of analysis (FMEA - Failure Modes and Effects Analysis), singularised application of method to the data concerning an organisation from German space. The results of authors’ demarche were materialised in both theoretical and practical considerations, presumptively useful for the specialists in the field of environment management, university environment and business environment.good practices, environmental performance, SMEs, system of management, quality

Attitude of Romanian Consumers Related to Products’ Ecological Labelling

The consumers play an important role in the protection of environment by their choices when they purchase products. Consequently, with a view to manufacture products with minimum impact on environment as well as to influence the conduct of consumers and improve the ecological performance of products and services, the ISO 14000 standards were elaborated for ecological labelling and analysis of life cycle of products and national and regional systems of ecological labelling of products were introduced. Also, in order to support a healthy and non-polluting environment, the European Commission adopted, pursuant to some specialised studies, a legislation related to the assignment of the condition of ecological product to different categories of products and services, having as purpose the environment protection and ensuring a durable consumption. At the same time, in order to improve the range of instruments of environment protection, financial and technical instruments were introduced as well The European Eco-Management and Audit Scheme – EMAS, but also the European ecological label Eco-label. The European ecological label is useful in order to supply to the consumers essential information that may allow them to make choices knowingly, acting as well as a passport that authorises the free circulation of products on the European territory. All the European Union’s states adopted the communitarian ecological label. Consequently, the integration of Romanian in the European Union imposed a range of measures related to the procedure of granting the ecological label. In Romania, there is a specific legislative frame concerning the determination of the procedure of granting the ecological label and of their conditions of use. Each group of products to which a label is assigned is governed by a specific legislation that sets forth the granting criteria. The main objectives of article concern the featuring of some fundamental elements related to eco-labelling by emphasizing the main theoretical-methodological and conceptual delimitations, the presentation of this phenomenon on international, European and national level, ending in an analysis related to the attitude of Romanian consumers towards the ecological labelling of products.eco-labelling, the European ecological label, eco-labelling in Romania, consumers

Perceptions of the Slow Food Cultural Trend among the Youth

As they become increasingly aware of the importance of healthy eating and of the serious food imbalance caused by the overconsumption of industrial, ultra-processed and superorganoleptic food, consumers are now beginning to turn their attention to food choices guaranteeing both individual health and also of the environment . Thus, in recent years we are witnessing the rise of a cultural trend ‒ Slow Food. Slow Food has become an international movement that advocates for satisfying culinary pleasure, protects biological and cultural diversity, spread taste education, links "green" producers to consumers and believes that gastronomy intersects with politics, agriculture and ecology. Slow Food proposes a holistic approach to food problem, where the economic, sociocultural and environmental aspects are interlinked, being pursued as part of an overall strategy. In order to highlight the manner in which the principles of this cultural trend are perceived by the representatives of the new generation of consumers in Romania, exploratory research marketing was conducted among the students in the second year of the master’s program Quality Management, Expertise and Consumer Protection, from the Faculty of Business and Tourism from the Buchares t University of Economic Studies . The results of this research have shown an insufficient knowledge of Slow Food phenomenon and, especially, the Slow Food network activity in Romania. To show that the Slow Food type of food is a healthier option towards which the future consumer demand should be guided, especially those belonging to the younger generation, an antithetical comparative analysis of the nutritional value of two menus was performed: a suggestive one for the Slow Food feeding style and other one, specific to the fast food style. Slow Food style was considered antithetical to the fast food because many previous studies have shown a preference of the young for the fast-food type products, despite the nutritional imbalance they generate. Comparative analysis of nutrition was produced by using the coverage degree method and the results have shown that the Slow Food type menu is a balanced food option. Given the issues that we highlighted, this paper can be a reference point in our endeavor to increase the awareness of the Romanian young people regarding the need to create a sustainable food system, in economic, environmental and socio-cultural point of view, as well as their orienting towards natural and healthy food options

Good Practices Preceding the Implementation of the System of Management of Environment, on Small and Medium Enterprises

The current and future economic context compel to ample reconsiderations related to the volume and content of the demarches carried out by organisations, in order to face the competition sharper and sharper and the more and more numerous rigors, among which the issue of environment is more than imperative. The good practices in environment management become more and more necessary and, fortunately, are supplied more and more often by organisations in SMEs category, which encounter highly valuable solutions in this context charged with convictions. This work features an exemplary performance of a small organisation that managed to settle an informal system of management of environment, built up with much rigour, involvement, respect for society and environment. The objectives of authors consist in offering good practices to business environment, from SMEs category, means of approaching in the analysis of environment practices and emphasizing the imperatives in this area of action, for organisations. The method of research included the consulting of some lists of specialised works, documentary study in the sites of the organisations from SMEs category and of the organisations in the field, adopting some established models of analysis (FMEA - Failure Modes and Effects Analysis), singularised application of method to the data concerning an organisation from German space. The results of authors’ demarche were materialised in both theoretical and practical considerations, presumptively useful for the specialists in the field of environment management, university environment and business environment

Antitumoral Drug-Loaded Biocompatible Polymeric Nanoparticles Obtained by Non-Aqueous Emulsion Polymerization

Non-aqueous dispersions (NAD) with two types of polymeric nanoparticles (NPs), such as hydrophobic poly(ε-caprolactone) (PCL) and hydrophilic cross-linked poly(vinylpyrrolidone) (PNVP), were synthesized in the present study starting from monomer-in-silicone oil (PDMS) polymerizable non-aqueous emulsions stabilized with the same tailor-made PDMS-based block copolymer. These NPs were loaded with CCisplatin, an antitumoral model drug, directly from the emulsion polymerization step, and it was observed that the presence of the drug leads only to a slight increase of the NPs size, from 120 to 150 nm. The drug release kinetics was evaluated at 37 °C in phosphate buffer at pH = 7.4 and it appeared that the drug release rate from the hydrophilic cross-linked PNVP-based NPs is higher than that from the hydrophobic PCL-based NPs. Moreover, haemolysis tests revealed the fact that these two types of NPs have a good compatibility with the blood. Furthermore, for both the free and drug-loaded NPs, the in vitro cytotoxicity and apoptosis was studied on two types of cancer cell lines, such as MCF-7 (breast cancer cell line) and A-375 (skin cancer cell line). Both types of NPs had no cytotoxic effect but, at a concentration of 500 μg/mL, presented an apoptotic effect similar to that of the free drug

Influence of ZnO Nanoparticles on the Properties of Ibuprofen-Loaded Alginate-Based Biocomposite Hydrogels with Potential Antimicrobial and Anti-Inflammatory Effects

Hydrogels are a favorable alternative to accelerate the burn wound healing process and skin regeneration owing to their capability of absorbing contaminated exudates. The bacterial infections that occur in burn wounds might be treated using different topically applied materials, but bacterial resistance to antibiotics has become a major problem worldwide. Therefore, the use of non-antibiotic treatments represents a major interest in current research. In this study, new antibiocomposite hydrogels with anti-inflammatory and antimicrobial properties based on hyaluronic acid (HA) and sodium alginate (AG) were obtained using 4-(4,6-dimethoxy-1,3,5-triazinyl-2)-4-methylmorpholinium chloride as an activator. The combination of Ibuprofen, a non-steroidal anti-inflammatory drug commonly used to reduce inflammation, fever and pain in the body, with zinc oxide nanoparticles (ZnO NPs) was used in this study aimed at creating a complex hydrogel with anti-inflammatory and antimicrobial action and capable of improving the healing process of wounds caused by burns. FTIR spectra confirmed the cross-linking of AG with HA as well as the successful incorporation of ZnO NPs. Using electronic microscopy, it was noticed that the morphology of hydrogels is influenced by the incorporation of ZnO nanoparticles. Moreover, the incorporation of ZnO nanoparticles into hydrogels also has an influence on the swelling behavior at both pH 7.4 and 5.4. In fact, the swelling rate is lower when the amounts of the activator, HA and ZnO NPs are high. A drug release rate of almost 100% was observed for hydrogels without ZnO NPs, whereas the addition of nanoparticles to hydrogels led to a decrease in the release rate to 68% during 24 h. Cellular viability tests demonstrated the non-cytotoxic behavior of the hydrogels without the ZnO NPs, whereas a weak to moderate cytotoxic effect was noticed for hydrogels with ZnO NPs. The hydrogels containing 4% and 5% ZnO NPs, respectively, showed good antimicrobial activity against the S. aureus strain. These preliminary data prove that these types of hydrogels can be of interest as biomaterials for the treatment of burn wounds

Topical formulations containing aptamer-functionalized nanocapsules loaded with 5-fluorouracil - An innovative concept for the skin cancer therapy

New topical gel formulations based on sodium alginate and hyaluronic acid containing AS1411 aptamer-functionalized polymeric nanocapsules loaded with an antitumoral drug (5-Fluorouracil) were designed as an innovative approach for the skin cancer treatment. Several important analyses were used to characterize these obtained topical gel formulations, namely: rheological tests, permeation assays across Strat-M® artificial membrane, ex-vivo permeation assays across chicken skin membrane, haemolysis tests, skin irritation tests, in vitro cytotoxicity assay on human basal carcinoma cells and in vivo tests. Rheological tests revealed that apparent viscosity decreases with the increase of the shear rate, for analyzed samples, which demonstrates a shear thinning behavior. Low levels of hemolysis values which ranged between 0.03 and 0.55% suggested that the tested formulations did not induce red blood cell lysis.. The gel formulations containing nanocapsules loaded with 5-FU proved to be non-irritant. Furthermore, by study the ex-vivo diffusion properties across the chicken skin membrane, it was proved that nanoencapsulation enhance the permeability properties of 5-FU. In vitro cytotoxicity assay on TE 354.T (ATCC® CRL-7762™) human basal carcinoma cell line showed that the obtained formulations loaded with 5-Fluorouracil manifest an important cytotoxic effect. Finally, the presence of Langerhans CD68 cells-positive in the epidermis and epithelial sheath of dermal hair follicles suggests a specific activation, migration and retrieval of nanoparticles by these cells. Following the results obtained in this study we can appreciate that the obtained topical gel formulations have a favourable biosafety and good antitumor effects which makes them attractive for skin cancer treatment

Assessment of Physicochemical and In Vivo Biological Properties of Polymeric Nanocapsules Based on Chitosan and Poly(N-vinyl pyrrolidone-alt-itaconic anhydride)

Drug delivery is an important field of nanomedicine, and its aim is to deliver specific active substances to a precise site of action in order to produce a desired pharmacological effect. In the present study nanocapsules were obtained by a process of interfacial condensation between chitosan (dissolved in the aqueous phase) and poly(N-vinyl pyrrolidone-alt-itaconic anhydride), a highly reactive copolymer capable of easily opening the anhydride ring under the action of amine groups of chitosan. The formed amide bonds led to the formation of a hydrogel membrane. The morphology of the obtained nanocapsules, their behavior in aqueous solution of physiological pH, and their ability to encapsulate and release a model drug can be modulated by the parameters of the synthesis process, such as the molar ratio between functional groups of polymers and the ratio of the phases in which the polymers are solubilized. Although a priori both polymers are biocompatible, this paper reports the results of a very detailed in vivo study conducted on experimental animals which have received the obtained nanocapsules by three administration routes—intraperitoneal, subcutaneous, and oral. The organs taken from the animals’ kidney, liver, spleen, and lung and analyzed histologically demonstrated the ability of nanocapsules to stimulate the monocytic macrophage system without producing inflammatory changes. Moreover, their in vivo behavior has been shown to depend not only on the route of administration but also on the interaction with the cells of the organs with which they come into contact. The results clearly argue the biocompatibility of nanocapsules and hence the possibility of their safe use in biomedical applications

Biocomposite Hydrogels for the Treatment of Bacterial Infections: Physicochemical Characterization and In Vitro Assessment

Hydrogels based on natural and synthetic polymers and inorganic nanoparticles proved to be a viable strategy in the fight against some Gram-positive and Gram-negative bacteria. Additionally, numerous studies have demonstrated the advantages of using ZnO nanoparticles in medicine due to their high antibacterial efficacy and relatively low cost. Consequently, the purpose of our study was to incorporate ZnO nanoparticles into chitosan/poly (vinyl alcohol)-based hydrogels in order to obtain a biocomposite with antimicrobial properties. These biocomposite hydrogels, prepared by a double crosslinking (covalent and ionic) were characterized from a structural, morphological, swelling degree, and mechanical point of view. FTIR spectroscopy demonstrated both the apparition of new imine and acetal bonds due to covalent crosslinking and the presence of the sulfate group following ionic crosslinking. The morphology, swelling degree, and mechanical properties of the obtained hydrogels were influenced by both the degree of covalent crosslinking and the amount of ZnO nanoparticles incorporated. In vitro cytotoxicity assessment showed that hydrogels without ZnONPs are non-cytotoxic while the biocomposite hydrogels are weak (with 3% ZnONPs) or moderately (with 4 and 5% ZnONPs) cytotoxic. Compared to nanoparticle-free hydrogels, the biocomposite hydrogels show significant antimicrobial activity against S. aureus, E. coli, and K. pneumonia