The Manufacturing Of DNA Vaccines

The Manufacturing Of DNA Vaccines A detailed design and layout of the facility for the manufacturing of DNA vaccines was developed. The factors foremost in the design and layout of the DNA vaccines facility were compliance to current good manufacturing practices (cGMP), regulatory guidelines, health, safety and environment, effective production, optimum material and personnel flow, effective cleanliness, minimisation of contamination and enhance maintenance. The total site area is 108m X 91m (9828m2) and plant/production area is 32m X 20m (640m2) with space for future expansion. To reduce the impact of airborne particles, relative humidity, pressure and temperature on the purity, efficacy, and safety DNA vaccines product, a containment/cleanrooms of class 100 was design with controlled-air environment with access via airlock, HVAC and high efficiency particulate air (HEPA) filters. In order to conform and comply to current good manufacturing practices (cGMP) and regulations, the following key component of cGMP were i ncorporated into the design, validation master plan (VMP), standard operating procedures (SOPs), appropriate quality control (QC), cleaning-in-place (CIP), sterilisation-in-place (SIP), trained personnel, documentation, health, safety and environment, utilities required and waste treatment process. The entire project timeline was estimated with the aid of Gantt chart project management technique to be a year and 4.5 months with reference to literatures on similar projects. 1.1 Introduction The demand for DNA vaccines for gene therapy, vaccination and for the treatment of diseases such as cancer, malaria, swine flu, HIV, melanoma, etc. is on the increase (Prather et al., 2003; Williams et al., 2009). This is because DNA vaccines triggers cellular and humoral immune responses, safe and stable (Prather et al., 2003). Therefore, there is need to design manufacturing facility for DNA vaccines production to meet the rising demand. However, the design, operations and layout of the manufacturing facility must conform and comply to standards, specifications and guidelines stipulated by regulatory authorities such as the U.S. Food and Drug Administration (FDA), Medicines and Healthcare products Regulatory Agency (MHRA), European Medicines Evaluation Agency (EMEA), World Health Organisation (WHO) and the regulation of the country in which the facility is to be constructed. In addition to meeting this regulations and guidelines the DNA vaccines production process, design and premi ses of its manufacture must conform to good design practices (GDP) and current good manufacturing practices (cGMP) (Shamlou, 2003; Przybylowski et al., 2007). The commercial scale production of DNA vaccines is justified by economics/cost, health, safety and environment, compliance to legal standards and production under Good Manufacturing Practices (GMP) (Shamlou, 2003). This is to ensure that manufacturing processes are controlled and performed according to design specifications and operational procedures in order to ensure that quality is built into the product (DNA vaccines) to assure safety, efficacy, purity and identity consistently (Przybylowski et al., 2007). In addition, GMP requirements are open ended, however the International Society of Pharmaceutical Engineers (ISPE) has enumerated the principal steps to current GMP which include standard operational procedures (SOPs), qualification and validation of process performance, design, quality control testing, adequate process control, sterilization in place (SIP), cleaning in place (CIP), layout design, quality management, documentation and audit of facility as necessary to ensuring specification and maintenance of product identity and compliance to regulations (WHO, FDA, MHRA, etc.) and current good manufacturing practices (cGMP) (Day, 2004). The issue of location for the manufacturing facility is crucial to its profitability as it is influenced by raw material supply, transportation, utilities, environmental impact, waste disposal, local community considerations, personnel, climate, plant size and availability of land (Sinnott, 2005). Moreover, before the design and installation of a new facility for pharmaceutical and biopharmaceutical product manufacture, an environmental impact assessment (EIA) is perform and approved (Davda, 2004). Hitherto, the design of any manufacturing facility must integrate the design of a treatment process and safe disposal of the waste generated to specified legal standards by regulatory authorities and eliminate/minimise harm to health and safety of personnel, environment and product contamination. The manufacturing facility layout must be designed to aid good raw material flow, waste flow and personnel flow around the factory to reduce risk, cross contamination and ensure that production ac tivities and factory operations are performed smoothly and follow a defined procedure. The pharmaceutical manufacturing process must be conducted in clean environment and clean rooms in which the temperature, pressure, air borne particles and relative humidity are controlled to specified conditions by regulators (U.S. FDA, WHO, ISO, MHRA, etc). All these are the component of current Good Manufacturing Practices (cGMP) to build quality assurance, consistency and safety of therapeutic product (DNA vaccines) to human life (Signore and Terry, 2008). The entire operations and activity should be performed by trained and competent personnel and quality management for a satisfactory quality assurance (QA/QC). 1.2 Aims and objectives 1. The defined goal of this project is to develop a detailed design and layout of a manufacturing facility for the production of DNA vaccines for commercial scale, applying current Good Manufacturing Practices (cGMP) and in compliance to regulatory guideline (FDA, FDA, MHRA, WHO, etc.). 2. Provide detail methods for qualification and validation of the design and layout, performance, quality control and enumerate the personnel/staff involved in the project. 3. Estimate the timeline of the project. 2.1 Process overview DNA vaccines production mainly starts on a bench scale through pilot scale to large scale production (Ferreira et al., 2000; Bequette et al., 2004). The design of a large scale facility for the manufacturing of DNA vaccines involves the selection of suitable plasmid DNA constructs/vectors (ColE1-type vectors, pUC vectors, pBR322 plasmid vector, etc.) that will replicate at high copy numbers, the production microorganism cell bank (Escherichia Coli), subsequently followed by fermentation process in the bioreactor under optimum conditions and control media (temperature, pH, pressure, etc.) to maximise cell growth, cell lysis to break the cells to release the DNA, isolation by precipitation of genomic DNA, cell debris, proteins and RNA, purification by anion exchange chromatographic technique because DNA is negatively charged, formulation and blending, sterile filling, packaging and storage in the fridge (Ferreira et al., 2000; Prather et al., 2003; Przybylowski et al., 2007).   2.2 Design of flowsheet The conceptual design of the process flowsheet for DNA vaccines production under cGMP was based on the knowledge of the process block diagram in Fig.1 above and the performance of the associated unit operations. The process flowsheet shown in Fig.2 is interconnection of the various unit operations, fermentation, the downstream processing (cell lysis, precipitation, clarification and concentration, primary purification (anion-exchange chromatography) and secondary purification (size exclusion chromatography)) and blending and formulation of the bulk product into usable form (Prazeres and Ferreira, 2004). Each pieces of equipment in the process flow sheet are designed to conform and comply with standard and code of practice of either International Organisation for Standardization (ISO), British Standard Institution (BSI), American Petroleum Institute (API), American Society for Testing Materials (ASTM), American National Standard Institution (ANSI), etc. to ensure safety, selection of suitable material of construction, and also equipment manufacturers work to produce facilities according to standardized design and size (Sinnott, 2005). Also each pieces of equipment are hygienically designed with good polished surfaces and piping for easy CIP and SIP, elimination of dead zones and sharp edges to avoid microbial growth and contamination and constructed with stainless steel material to eliminate contamination. The final product DNA vaccines are sterilely filled into vials and stored at -20oC in the freezer (Przybylowski et al., 2007). 3.1 Site layout design The site layout was designed to prevent product contamination, environmental pollution and to safeguard the health and safety of personnel. The various unit operations shown on the process flowsheet in Fig.2 and the ancillary buildings required to support the manufacturing facility for DNA vaccine production are laid out to give an economical flow of raw materials to final product storage, flow of personnel and waste around the production site to conform to good manufacturing practice (GMP), reduce risk and product contamination (Sinnott, 2005; Signore and Terry, 2008). The site layout design in Fig.3 was done with consideration to future expansion of the DNA production. Clean rooms, waste treatment area, hazardous process and raw materials were isolated and arranged for safety of product, personnel and environment. The size of the site is 108m X 91m (9828m2) as shown in Fig.3 and the ancillary buildings and support services required for the manufacturing facility are: Storages for raw materials and DNA vaccines. Quality control laboratory. Maintenance workshops and warehouse. Utilities: steam, compressed air, power generation, refrigeration, water (WFI), CO2, N2 etc. Cleaning-in-place (CIP) and Sterilisation-in-place (SIP). Effluent treatment and disposal plant. Process control room Administrative offices Fire stations and other emergency services Amenities required include: roads and car parks, first aid centre, canteen, security, rest room, changing room, training room and visitors centre. 3.2 Facility layout design The detailed design and layout of the DNA vaccines production rooms and equipment is designed to minimise risk, reduce cross contamination, permit effective cleaning and sterilisation of external and internal surfaces of process equipment by the use of clean in place (CIP) and sterilisation in place (SIP), enhance maintenance and control of clean rooms temperature, pressure and relative humidity (RH) under standard operating procedures (SOPs) (Przybylowski et al., 2007). The facility layout design also considered the cleanrooms, equipment and the flow of materials and personnel as key factors that impact on manufacturing cost, operational procedures and productivity (Drira et al., 2007). The DNA vaccines manufacturing facility layout design is 32m X 20m (640m2) in size as shown in Fig.4 to ensure efficiency and safety of the production environment and manufacturing process which are dependent on the layout of the facility (Jacobson et al., 2002). 3.2.1 Cleanrooms/containment design One of the principles of GMP is cleanliness and aseptic operations to prevent product contamination by microorganisms, particulate generated during plant operations and changes in room conditions (temperature, relative humidity, etc.). Therefore, DNA vaccines which are biological drugs are manufactured in clean rooms, that is, a room in which the air quality (airborne particles), the temperature, the pressure and relative humidity are controlled to prevent contamination by impurities, dust and microorganisms in the atmosphere and in the ambient air, in order to protect its purity, efficacy and safety (Sutherland, 2008). The layout and design of the production rooms was according to the International Standards Organisation (ISO) 14644-1 cleanrooms classification shown in Table 2 below. The raw materials, fermentation, purification, blending and formulation and product storage clean rooms are designed for class 100 biosafety cabinet fitted with high efficiency particulate air (HEPA) fi lters and HVAC systems to ensure the entry of clean air into the cleanrooms and exit of dirty air inside the rooms (Sutherland, 2008). The flow of air in and out of the cleanrooms is laminar. Other components of the cleanrooms include: Separate airlocks for entry and exit doors for personnel, raw materials and waste products. An inlet port for fresh purified air. An exit vents fitted with activated carbon filter to purify contaminated air before discharge to ensure environmental safety (Sutherland, 2008). Cleanrooms air pressure is maintained below atmospheric to prevent outward leakage. Nonslip floors, electricity, light appropriate and aseptic processing hood. Humidifiers to maintain and control cleanrooms relative humidity and temperatures 4.1 Raw materials Variations in raw materials composition is known to impact on the quality of DNA vaccines produced and also the operations of the plant. Therefore, raw materials require quality control check before used. The raw materials, reagents and utilities required for the DNA vaccines manufacturing facility are: plasmid DNA vectors, nutrients, glucose, water for injection (WFI), sterile air, salt, buffer capacity (to stabilise pH of fermentation), liquid nitrogen N2, and antibiotic, alkaline, master cell bank (MCB) and working cell banks (WCB). These are placed in the quarantine storage room and undergo quality control testing to ensure that specification are met before used for DNA vaccines production for quality assurance (QA/QC). The flow of materials from the raw materials to the final product (DNA vaccines) is shown in FIG. above and the final DNA vaccines products are stored in a sterile room in a freezer at -20oC (Przybylowski et al., 2007). 4.2 Personnel The compliance to current good manufacturing practices (cGMP) and regulatory guideline depends on people and good management structure. It is essential when developing new facility to integrate all relevant personnel from production, logistics, quality control and engineering in the inception phase of the design and layout. Therefore, for a satisfactory quality assurance of the DNA vaccines production, facility design and layout, the interactions and inputs from various disciplines such as chemists, chemical engineers, biochemical engineers, biologists, microbiologist, pharmacists, civil engineers, project managers, mechanical engineers, electrical engineers, architect, cost engineer and many others are required to carry out defined tasks and responsibilities. The flow of personnel around the designed facility layout during operations is shown in FIG. 4.3 Qualification and validation The qualification and validation of pharmaceutical manufacturing facilities at regular intervals is an integral part of good manufacturing practices (GMP). This is documentary evidence that assures that the DNA vaccines production facility is performing satisfactorily and consistently to specification for the intended purpose (Day, 2004). To do this, a validation master plan (VMP) is drawn up which include: design qualification (DQ), installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) to confirm that all was done according to specifications (Day, 2004; Chaloner-larsson et al., 1997). However, an internal audit of the facility and instruments is also conducted to ensure compliance and implementation of cGMP and regulatory guidelines. 4.3.1 Design qualification (DQ) Design qualification is carried on the following production pieces of equipment of the manufacturing facility such as bioreactor, centrifuge, anion-exchange chromatography, size exclusion chromatography, microfiltration system, ultra-filtration system, HVAC systems and lyophilizer, for verification and documentation as a prove to show that the equipment designs conforms to regulatory standards such as ISO 9000, BSI, etc. 4.3.2 Installation qualification (IQ) The IQ is a documented verification that confirms that the manufacturing facility layout, HVAC systems, supporting utilities (steam, CIP, SIP, etc.) and process equipment are built and installed in compliance to the designed specification and manufacturers recommendations (Chaloner-Larsson et al., 1997). The IQ document for each equipment/system contains name of equipment/system, description, model and identification number, the location, utility requirements, any safety feature, date, personnel and approver. 4.3.3 Operational qualification (OQ) The OQ is the documentary verification of the manufacturing facility to confirm that each pieces of equipment operates in accordance to designed specifications and operation conditions and will consistently (Day, 2004). This is accomplished by testing control systems, alarms, switches, and providing standard operations procedures (SOPs) for the operations of the manufacturing facility. 4.3.4 Performance qualification (PQ) Performance qualification (PQ) is a documented verification that confirms that the manufacturing facility and the supporting utilities will consistently perform to required specification under the designed operating ranges to production the DNA vaccines. The following systems and pieces of equipment are validated for performance check: purification processes, bioreactor, HVAC systems, autoclave, CIP, SIP, oven, pure steam generation system, purified water and water for injection systems, centrifuge and lyophilizer. 4.4 Quality assurance and Quality control (QA/QC) The consistent production of DNA vaccines to meet therapeutic specification of safety, purity, efficacy and potency depends on good quality assurance and quality control (QA/QC) performed by qualified persons (QP). Quality control of the DNA vaccines is one of the key component of current good manufacturing practices (cGMP) and regulatory guideline of U.S. FDA, WHO, MHRA, ISO 9000 etc. It involves testing procedures employed to check that the DNA vaccines product are uniform from batch-to-batch and raw materials used for its production meet the specification, quality and standard. The quality control testing laboratory consists of the following assays for determining quality of raw materials and product purity, efficacy and safety: High performance liquid chromatography (HPLC) to determine the percentage of RNA, supercoiled and nicked. pH meter test for residual buffer salts and alkaline. Agarose gel electrophoresis (AGE) test for plasmid DNA vaccine purity, determine RNA and genomic DNA presence in the product. Gas chromatography test for the presence of ethanol, determine plasmid size Flame ionization detector (FID) test for the presence of isopropanol in the product. Transfection/Immunofluorescent staining test for potency of plasmid DNA vaccines. Kinetic chromogenic limulus amoebacyte lysate (LAL) test to quantify the presence of endotoxin in the product Sodium dodecylsulfate polyacrylamide gel electrophoresis (SDS-PAGE) test for the quantity of proteins in the product (DNA vaccines). GeneQuant spectrophotometer test to quantify the purity of the DNA vaccines product. Bicinchoninic acid (BCA) assay quantify the amount of proteins present in the bulk product. Mass spectrometer, measuring, weighing, recording and control instruments calibrated regularly. The analytical instruments are validated to ensure performance. The DNA vaccines must meet at least minimum specification, purity, efficacy, safety and quality set by regulatory authority after sterile filling before released (Przybylowski et al., 2007; Prather et al., 2003). 4.4.1 Product testing Prior to the release of the DNA vaccines after blending and formulation, the quality control department must test each batch for purity, identity, efficacy, safety and potency using the analytical assays mentioned above, and if the result does not meet regulatory specifications the batch will not be released (Prazeres and Ferreira, 2004). Table 1 below shows an example of DNA vaccines purity and quality specification. 4.5 Documentation Documentation of all the activities and operations is a key requirement for GMP, regulatory bodies, and helpful for management structure, traceability of every batch history, planning, elimination of errors, effective communication, records keeping and design and layout of the DNA vaccines facility. Regulatory authorities such as FDA, EMEA and WHO require documentary evidence as prove that the DNA vaccines facility will perform consistently in compliance to cGMP. The DNA vaccines project documentation include: standard operational procedures (SOPs), design qualification, installation qualification, facility layout design, specification sheets for each pieces of equipment, performance qualification, quality control records, process flow sheet, site plan, personnel records, licence, commissioning, validation master plan (VMP), packaging, labelling, etc. both on paper and electronically (Signore and Terry, 2008; Sinnott, 2005). 4.6 Utilities Utilities are the support services required for effective design, layout and manufacturing process of DNA vaccines, they include: Potable water, USP purified water used for cleaning in place (CIP) to clean process equipment. Water for injection (WFI) used for media preparation, fermentation media and rinsing of equipment after CIP. Clean steam for sterilisation in place (SIP) to sterilise the process equipment after each batch. Electricity for lightening, instrumentation, analytical instrument, etc. Sterile gases such as filtered sterile air for fermentation process, nitrogen N2 for working cell bank storage, heating, ventilation and air-conditioning (HVAC) system. Refrigeration for the storage of the DNA vaccines product at -20oC. 4.6.1 Heating, Ventilation and Air-Conditioning (HVAC) System Heating, ventilation and air-conditioning (HVAC) system is a component of the production clean rooms design and layout, it plays a vital role in ensuring that the manufactured DNA vaccines product quality, efficacy, safety and purity is not impacted by room temperature, relative humidity (RH), air borne particles, pressure and cross contamination in accordance to standards and classifications of rooms by ISO 14644-1, US Fed. Std. 209, BSS5295, EEC, etc. (Zyl, 2005). The HVAC systems for this manufacturing facility include: High efficiency particulate air (HEPA) filters to control air borne particles, dust and microorganisms of the clean rooms. Desiccant dehumidifiers/refrigerated dehumidifiers are used to monitor and control the temperature and relative humidity (RH) of the rooms in order to comply with raw materials and DNA vaccines product requirement. Airlocks and air handling unit (AHU) are put in place for pressure monitoring, control and maintenance of pressure cascade with the production rooms. 4.6.2 Water and clean steam systems Purified water, water for injection (WFI) and clean steam are essential utilities generated on site and distributed for use in DNA vaccines production, clean-in-place (CIP), sterilisation-in-place (SIP), and media preparation (Robbins, 2010). In order to ensure safety, purity and efficacy of the DNA vaccines the water used for its production is sterile water for injection (WFI). The WFI is produced from purified water by distillation/reverse osmosis to meet the required standard of purity specified by the United State Pharmacopeia (USP) (pH 5.0-7.0, nonpyrogenic and antimicrobial agent). The WFI is stored at elevated temperature (80-95oC) to eliminated microbial growth, and the system constructed with stainless steel to eliminate contamination (Robbins, 2010). The WFI system design is shown in FIG. 4.7 Waste treatment and management The system for treating the waste generate from the DNA vaccines manufacturing facility is an integral part of the design of the facility, layout and good manufacturing practices (GMP). The major waste generate from the production process are genomic DNA of the host cells, RNA, proteins, cell debris, salts, endotoxins and plasmid isoforms (Ferreira et al., 2000). The waste is treated to regulatory standards (BS, ISO, etc.) to avoid harm to health and safety of personnel and environment (HSE), pollution and eliminate cross contamination of the product. The system for treating the waste is illustrated in FIG. below WWWW Incineration Autoclaved Waste Discharge Autoclave 4.7.1 Health, Safety and Environment (HSE) The DNA vaccines production microorganism poses some hazard. The environmental impact assessment (EIA) of the DNA vaccines production system therefore becomes a key part of the design and layout of the manufacturing facility (Prazeres and Ferreira, 2004). However, the environmental impact assessment (EIA) study and the design will require approval from environmental protection agency before the facility is built (Davda, 2004). To ensure that health, safety and environmental regulations are met, the process design and layout is geared towards minimisation of waste generation, safety of product, safety and health of personnel and incorporation of waste treatment process before discharge to the environment. In addition, the personnel will also be provided with personal protective equipment (PPE) such as hand gloves, gowns, goggles, etc. to work with. 4.8 Legislation and regulation The manufacture of DNA vaccines is highly regulated to ensure that it is safe, efficacious and pure for humans, and also its production carried out in accordance to current GMP (Plumb, 2005). Therefore, before the DNA vaccines can be marketed they must be licence from the relevant regulatory bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom, the Food and Drug Administration (FDA) in the United States, the EMEA, WHO and so on (Smith and Dennis, 2001). The manufacturing facility used for the production of the DNA vaccines must be licence too (Plumb, 2005). These licences are obtained if and only if the manufacturing facility design, layout and premises of its manufacture conform and comply to current good manufacturing practices (cGMP) and with regulatory standards, guidelines and specifications stipulated by MHRA, FDA, WHO, EMEA, ISO, etc. Hitherto, the company must also provide detailed documentary evidence about the safety, purity an d efficacy of the DNA vaccines and the consistency of its manufacturing process. Signor and Terry reported that the incorporation of current good manufacturing practices (cGMP) into good design practices (GDP) at the inception of the manufacturing facility will ensure that regulatory conditions are met (Signor and Terry, 2008). The regulatory guidelines specify the requirements for the pharmaceutical manufacturing facility, not the methods to achieving it. The regulatory bodies functions include: safeguard public health, licensing, monitoring DNA vaccines post-marketing, regulating clinical trials and publish quality standards. 5.1 Project timeline This project has a definite start, middle and end, which consist of several activities ranging from the environmental impact assessment and design approval, construction to commissioning executed in a defined order to bring the project to completion. It is the function of the project manager to plan, schedule and control these tasks/activities in a specified sequence and allocate materials, manpower, machinery and money to ensure that the project is completed on time (Gray and Erik, 2008). There are several project management techniques available in the literature, but to estimate the timeline of this project the Gantt chart technique was employed, which a plot of each task against time. Each bar represents a task/activity, length of the bar corresponds to the duration of the task and the position indicate the start and finish times. The timeline for key activities of the project are shown in FIG!!!!!!!!!!!!!! below, the Gantt chart was prepared with reference to (Davda, 2004). The e ntire project is expected to take a year and 4.5 months from the Gantt chart. 6.1 Recommendations 1. Legislations and regulations are subject to changes with emergent of robust technology, therefore the design of the manufacturing facility should be above the current specifications and standards. 2. A well defined and detail engineering drawings and specifications that does not require much interpretation. 3. A good relationship between project design team with relevant regulatory authorities and encouragement of their input will fortify the design of the facility and compliance to cGMP. 4. Ensure that all designs, installations and utilities are validated according to validation master plan (VMP) and are working according to design and specification of regulatory bodies. 5. Compliance with current good manufacturing practices (cGMP) at the inception of the design phase of the facility. 6. The DNA vaccines production facility should be designed and layout to harmonized the various regulations by different bodies such the US FDA, UK MHRA, EU, Japan, ISO, WHO, etc. to boost market for the product. 7. The process parameters such as temperature, pH and pressure must be carefully controlled to assure batch-to-batch identity in final product. 7.1 Conclusion Incorporating current good manufacturing practices (cGMP) from the beginning of the design and layout phase of the DNA vaccines facility, the production processes and to the manufacturing premises will ensure that all regulatory specifications are met.

Working Paper

The term module means that the questionnaire can be used as part of a larger Research experience has shown that the answers to the 24 content questions are influenced by the nationality of the respondents. This is not to say that every respondent of nationality A gives one answer and everyone of a nationality B another, but one can expect systematic differences between the average answers from a sample with nationality A and a comparable sample from nationality B (in statistical terms, an analysis of variance on the answer scores shows a significant country effect).As the relationship is statistical, the samples per country should be of sufficient size. An ideal size for a homogeneous sample is 50 respondents. Sample sizes smaller than 20 should not be used, as outlying answers by single respondents will unduly affect the results. If samples are heterogeneous (composed of unequal sub-samples) these numbers apply to the sub-samples. Next to nationality, answers to the 24 content quest ions will also reflect other characteristics of the respondents, such as their gender, age, level of education, occupation, kind of work and the point in time when they answered the questions.Therefore comparisons of countries should be based on samples of respondents who re matched on all criteria other than nationality that could systematically affect the answers. The content questions attributed to a dimension were selected because in comparisons of matched samples from ten or more countries, the mean country scores on the four questions belonging to the same dimension usually vary together (if one is high, the other is high, or low if it is a reversely formulated question; if one is low, the other is low, etc. ). In statistical terms, the mean country scores are significantly correlated.The mean country scores on questions belonging to different emissions usually do not vary together (are uncorrelated). Therefore, the 24 questions form 6 clusters of 4 questions each. As mentione d above, the dimensions measured by the VS.. Are based on country- level correlations, between mean scores of country samples. For the same two questions, country-level correlations can be very different from individual-level correlations, between the answers by the individuals within the country samples (for a clear explanation see e. G. Klein, Danseuses & Hall, 1994).Individual-level correlations produce dimensions of personality; country-level correlations produce emissions of national culture. For research results about the relationship between personality and culture see Hefted & McCrae (2004). The study of national culture dimensions belongs to anthropology, the study of individual personality belongs to psychology. The first is to the second as studying forests is to studying trees. Forests cannot be described with the same dimensions as trees, nor can they be understood as bunches of trees.What should be added to the animals, organisms and climate factors, together described by the term epitome. In reverse, trees cannot be described with the same dimensions as forests. At best one can ask in what kind of forest this tree would be most likely found, and how well it would do there. A common misunderstanding about dimensions of national culture is that they are personality types. People want to score themselves on a dimension, or worse, try to score someone else. This is called stereotyping, which is not what the dimensions are for.They do not refer to individuals, but to national societies. What a person can do is find out how the values prevailing in his or her national society differ from those in another society. As an individual, a person can express how he or she feels about the values in a particular national society, but that would still be a function of his/her personality and not necessarily show his or her national culture. Because of this, the VS.. 2013 cannot be scored at the individual level. It is not a psychological test.The tendency to as k for individual scoring of the VS.. Is stronger in some national cultures than in others. Especially in very individualist cultures, the request for individual scoring is frequent: the concept of my society (a forest) is weaker that the concept of me myself (a tree). The VS.. Should only be used by researchers who subscribe to the concept of a society differing from other societies. The six dimensions on which the VS.. 2013 is based were found in research across more than 40 countries.In a research project across 20 different organizations within the same two countries, answers to the questions that made up the cross-national dimensions did not correlate in the same way (Hefted, Enquire, Omaha' & Sanders, 1990 and Hefted, Hefted & Moving, 2010: 341-368). So the cross-national dimensions do not apply to organizational (or corporate) cultures. The answers to the VS.. Questions (dealing with values and sentiments) varied less across organizations within a country than across countries .Instead, organizational cultures differed primarily on the basis of perceptions of practices, and the organizations in the study could be compared on six dimensions of perceived practices. While the study of national culture dimensions belongs to anthropology and the study of individual personality belongs to psychology, the study of organizational cultures belongs to sociology. The dimensions of perceived practices in the Hefted et al. 1990) study relate to known distinctions from organizational sociology. A similar concern prohibits the use of the VS.. Dimensions for comparing occupations (Hefted, Hefted & Moving, 2010: 368-369).In some cases, VS.. Dimension scores can be meaningfully computed and compared for the genders (female versus male) and for successive generations (grandparents country or across countries, but in this case we recommend extending the questionnaire with locally relevant items (Hefted, Garibaldi, Melville, Tenure & evokes, 2010). 4. VS.. 2013 scores are not comparable to published scores Some enthusiastic amateurs have used the VS.. With a sample of respondents from one country and tried to draw conclusions comparing the scores they found with those in Hypotheses books (1980, 1991 , 2001 , 2005, 2010).But essential to the use of the VS.. Is that comparisons should be based on matched samples of respondents: people similar on all criteria other than nationality that could systematically affect the answers. All scores in the first two Hefted books were based on carefully matched IBM subsidiary populations. A new sample, to be comparable to these, should be a attach for the original IBM populations on all relevant criteria. Such a match is virtually impossible to make, if only because the IBM studies were done around 1970 and the point in time of the survey is one of the matching characteristics.Hypotheses books since 2001 contain scores for a number of countries not in the original IBM set, based on extensions of the research outside MO M, or in a few cases on informed estimates. Extensions of the research to countries and regions not in the original set have to be based, like any VS.. Application, on matched samples across two or more countries. These should always include one or, if possible, more of the countries from the IBM set, so that the new data can be anchored to the existing framework. Anchoring' means that the scores from the extension research should be shifted by the difference of the old and new scores for the common country (or by the mean difference in the case of more common countries). The main problem of extension research is finding matched samples across new and old countries. Examples of successful extensions are described in Hefted (2001:464-465). The VS.. 2013 has been designed for research purposes. In the classroom it has poor ace validity, as it is based on the logic of national cultures which differs from the logic of individual students. Cultures are not king-size individuals: They are wholes, and their internal logic cannot be understood in the terms used for the personality dynamics of individuals. Echo-logic differs from individual logic† (Hefted, 2001 :17; the term ecological in cross-cultural studies is used for any analysis at the societal level; it does not only refer to the natural environment). To students or audiences without a professional training in anthropology or cross-cultural research the VS.. Is to the proper tool for explaining the essence of the dimensions.In this case trainers should rather develop teaching tools using the tables of differences between societies scoring high and low on each dimension, which are based on significant Hefted & Moving, 2010: Chapters 3-8). The twenty-four content questions allow index scores to be calculated on six dimensions of national value systems as components of national cultures: Power Distance (large vs†¦ Small), Individualism vs†¦ Collectivism, Masculinity vs†¦ Femininity, Uncertaint y Avoidance (strong vs†¦ Weak), Long- vs†¦ Short-Term Orientation, and Indulgence vs†¦ Restraint.All content questions are scored on five-point scales (1-2-3-4-5). Any standard statistical computer program will calculate mean scores on five-point scales, but the calculation can also be done simply by hand. For example, suppose a group of 57 respondents from Country C produces the following scores on question 04 (importance of security of employment): 10 x answer 24 x answer 2 14 x answer 3 5 x answer 4 1 x answer 5 42 20 54 valid answers totaling 125 Three of the 57 respondents gave an invalid answer: either blank (no answer) or multiple (more than one answer).Invalid answers should be excluded from the calculation (treated as missing). The mean score in our case is: 125/54 = 2. 31. Mean scores on five-point scales should preferably be presented in two decimals. More accuracy is unrealistic (survey data are imprecise measures). Power Distance Index (PDP) Power Distanc e is defined as the extent to which the less powerful members of institutions and organizations within a society expect and accept that power is distributed unequally. The index formula is PDP = 35(mom – mom) + 25(mom – mom) + QPS) in which mom is the mean score for question 02, etc.The index normally has a range of about 100 points between very small Power Distance and very large Power Distance countries. C(PDP) is a constant (positive or negative) that depends on the nature of the samples; it does not affect the comparison between countries. It can be chosen by the user to shift her/his PDP scores to values between O and 100. Individualism Index (DIVIDE) Individualism is the opposite of Collectivism. Individualism stands for a society in which the ties between individuals are loose: a person is expected to look after himself or herself and his or her immediate family only.Collectivism stands for a roofs, which continue to protect them throughout their lifetime in exc hange for unquestioning loyalty. DIVIDE = 35(mom – mol) + 35(mom – mom) + C(ICC) in which mol is the mean score for question 01, etc. The index normally has a range of about 100 points between strongly collectivist and strongly individualist countries. C(ICC) is a constant (positive or negative) that depends on the nature of the samples; it does not affect the comparison between countries. It can be chosen by the user to shift his/her DIVIDE scores to values between O and 100.Masculinity Index (MASS) Masculinity is the opposite of Femininity. Masculinity stands for a society in which social gender roles are clearly distinct: men are supposed to be assertive, tough, and focused on material success; women are supposed to be more modest, tender, and concerned with the quality of life. Femininity stands for a society in which social gender roles overlap: both men and women are supposed to be modest, tender, and concerned with the quality of life. MASS = 35(mom – mom ) + 35(mom – mom) + corn) in which mom is the mean score for question 05, etc.The index normally has a range of about 100 points between strongly feminine and strongly masculine countries. C(MFC) is a constant (positive or negative) that depends can be chosen by the user to shift her/his MASS scores to values between O and 100. Uncertainty Avoidance Index (AJAX) Uncertainty Avoidance is defined as the extent to which the members of institutions and organizations within a society feel threatened by uncertain, unknown, ambiguous, or unstructured situations. AU' = 4001118 – mom)+ 25(mom – mom) + qua) in which mom is the mean score for question 18, etc.The index normally has a range of about 100 points between weak Uncertainty Avoidance and strong Uncertainty Avoidance countries. C(AU) is a constant (positive r negative) that depends on the nature of the samples; it does not affect the comparison between countries. It can be chosen by the user to shift his/her I-JAG scores to values between O and 100. Long Term Orientation is the opposite of Short Term Orientation. Long Term Orientation stands for a society which fosters virtues oriented towards future rewards, in particular adaptation, perseverance and thrift.Short Term orientation stands for a society which fosters virtues related to the past and present, in particular respect for tradition, preservation of â€Å"face†, and fulfilling social obligations. LTO = – mom) + 25(mom – mom) + C(IS) n which mom is the mean score for question 13, etc. The index normally has a range of about 100 points between very short term oriented and very long term oriented countries. C(l's) is a constant (positive or negative) that depends on the nature of the samples; it does not affect the comparison between countries. It can be chosen by the user to shift her/his L TO scores to values between O and 100.Indulgence versus Restraint Index (IVR) Indulgence stands for a society which allows rel atively free gratification of some desires and feelings, especially those that have to do with leisure, merrymaking with rinds, spending, consumption and sex. Its opposite pole, Restraint, stands for a society which controls such gratification, and where people feel less able to enjoy their lives. The index formula is IVR = – ml 1) + – mom) + COO in which ml is the mean score for question 11, etc. The index normally has a range of about 100 points between high indulgence and high restraint.C(IR) is a constant (positive or negative) that depends on the nature of the samples; it does not affect the comparison between countries. It can be chosen by the user to shift her/his IVR scores to values between O and 100. As country-level correlations differ from individual-level correlations, answers on questions used to measure a country-level dimension do not necessarily correlate across individuals. A reliability test like Cockroach's alpha should in this case not be based on individual scores but on country mean scores. Obviously this presupposes data from a sufficient number of countries, in practice at least ten.For comparison across fewer countries the reliability of the VS.. At the country level has to be taken for granted; it can indirectly be shown through the validity of the scores in predicting dependent variables. The IBM database (Hefted, 1980) allows to compute Cockroach alphas for the first four dimensions across 40 countries (39 for AAU, 33 for PDP because of missing data). Power Distance Index (3 items): Alpha = . 842 Individualism Index (6 items): Alpha = . 770 Masculinity Index (8 items): Alpha = . 760 Uncertainty Avoidance Index (3 items) Alpha = . 15 The rule of thumb for test reliability is a value over . 700. The new items in the new version were chosen because of their similarity to items in reliable other studies, but the reliability of the new dimension scores cannot be proven a prior'. The VS.. 2013 is copyrighted, but may be fre ely used for academic research projects. Consultants who want to use the VS.. 2013 periodically should pay a license fee based on the number of copies administered per year. The same holds for use by companies in employee surveys. Information on rates is available from the copyright holder ([email  protected] L) 9. History of the VS.. 2013 The original questions from the 1966-1973 Hermes (MOM) attitude survey questionnaires used for the international comparison of work-related values were listed in Hefted (1980, Appendix 1). Appendix 4 of the same book presented the iris Values Survey Module for future cross-cultural studies. It contained 27 content questions and 6 demographic questions. This VS.. 80 was a selection from the IBM questionnaires, with a few questions added from other sources about issues missing in the IBM list and Judged by the author to be of potential importance.In the 1984 abridged paperback edition of Hefted (1980) the original IBM questions were not included, but the VS.. 80 was. A weakness of the VS.. 80 was its dependence on the more or less accidental set of questions used in the IBM surveys. The IBM survey questionnaire had not really been imposed for the purpose of reflecting international differences in value patterns. However, the IBM questions could only be replaced by other questions after these had been validated across countries; and to be validated, they had to be used in a large number of countries first.Therefore in 1981 Hefted through the newly- founded Institute for Research on Intercultural Cooperation (IIRC) issued an experimental extended version of the VS.. (VS.. 81). On the basis of an analysis of its first results, a new version was issued in 1982, the VS.. 82. This was widely used for the next twelve years. 3 of the questions were needed to compute scores on the four dimensions identified by Hefted. The other questions were included for experimental use. Some questions in the VS.. 82 were only applicable to employe d respondents.Thus the instrument could not be used for entrepreneurs, students, and respondents without a paid Job. The number of replications using the VS.. 82 in Iris's files increased, but, unfortunately, it turned out that the samples from different researchers were insufficiently matched for producing a reliable new VS†¦ This changed when Michael Hope published his Ph. D. Hess on a survey study of elites (Syllabus Seminar Alumni) from 19 countries, using among other instruments the VS.. 82 (Hope, 1990). Eighteen of these countries were part of the IBM set, but besides USA all of them were from Europe.Hope's data base was therefore extended by adding results from replications in six countries in Africa, Asia and Latin America that could be considered somewhat matched with the Hope set. In the meantime, the research of Michael Harris Bond from Hong Kong, using the Chinese Value Survey (Chinese Culture Connection, 1987), had led to the identification f a fifth dimension: Lon g-Term versus Short-Term Orientation (Hefted & Bond, 1988; Hefted, 2001: Chapter 7). In the new version of the VS.. Published in 1994 (the VS.. 94), this dimension appeared for the first time together with the other four.The questionnaire was also adapted to respondents without a paid Job. Accumulated experience with the use of the VS.. 94 in the next 14 years led to the publication of an updated VS.. 08. In the meantime, many new sources of cross- cultural survey information became available. One was an unpublished Master's Thesis (Van Bug, 2006) reporting on the Internet administration of the VS.. 94 among active members of the student association EASIES in 41 countries, collecting some 2,200 valid answers, a response rate of 24%.We also looked for questions correlated with the IBM dimensions in the newly available sources, including the huge World Values Survey database freely accessible on Internet (Ingather and associates, 1998, 2004, 2007). In 2007, Michael Moving published a book integrating all available old and new databases, and we invited him to Join the VS.. Team. Moving (2007) proposed three new dimensions: Exclusion versus Universalism, Indulgence versus Restraint, and Monumentality versus Flexibility (flexibility plus nullity).From these, Exclusion versus Universalism across 41 countries was strongly correlated with Power Distance and Collectivism (both r = . 74), so we did not treat it as a new dimension. Indulgence versus Restraint was uncorrelated with any of the five dimensions in the VS.. 94 and it added new insights into national cultural differences, so we accepted it as a new and sixth dimension. Monumentality versus Flexibility was significantly correlated with Short Term Orientation (r = . 68 across 16 overlapping countries) and less strongly with Power

The Characteristics Of Autism Spectrum Disorders ( Asd )

1. What are the characteristics of Autism Spectrum Disorders (ASD)? As described in the textbook, there is a broad range of characteristics associated with Autism Spectrum Disorders (ASD). One of the first characteristics noted with ASD is language deficits, or using language in â€Å"odd† ways. As stated in the textbook, â€Å"Children with classic autism may be nonverbal. Alternatively, they may have significant language difficulties, so that their language may consist primarily of echolalia or delayed echolalia†, (E. Amanda Boutot, 2011, pp. 6,9). Additionally, â€Å"Children with Asperger Syndrome (AS) frequently have difficulty in conversations and following up on statements made by others†, (E. Amanda Boutot, 2011, p. 18). Individuals with AS may also take a literal interpretation of language, as well as, speak with an unusual volume, pitch, or rate. 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American Literature - 11652 Words

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