Evaluation of product x pre and post cpv implementation
- Authors: Killian, Christopher Grant
- Date: 2020
- Subjects: Pharmaceutical industry
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/46447 , vital:39577
- Description: Purpose: Stage 3 of the pharmaceutical process validation lifecycle, is called continued process verification (CPV). CPV is the final stage of lifecycle management and is intended to provide ongoing assurance that during routine production that a process remains in a state of control. Since CPV is a relatively new focus area for regulators, many legacy products will not have undergone Stage 3 process validation. Therefore, an opportunity existed to review the impact and challenges of implementing CPV on a legacy product. Methodology: This study employed quantitative analysis to evaluate the impact of CPV on process stability and end product quality for Product X, a legacy product manufactured at a generics manufacturing facility. Initial Stage 3a CPV was used to review historical process data and identify special cause variation. Corrective and preventative actions were taken to address these statistical outliers and the impact of these process changes were evaluated in Stage 3b. Results: CPV implementation appeared to have an effect on process control, stability and capability for Product X. In Stage 3b, an increase in statistical outliers along with significant changes to process mean and standard deviation were seen for the critical process parameters, average mass and hardness. An improvement in process capability for the critical quality attributes, assay and dissolution, was also seen. Conclusion: The largest benefit of CPV implementation, especially for a legacy product, is the process knowledge gained. This provided opportunities for process improvement and ultimately benefited patient safety.
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- Date Issued: 2020
Synthesis of fluorescent polymers with pendant triazole-quinoline groups via raft polymerization
- Authors: Ngororabanga, Jean Marie Vianney
- Date: 2014
- Subjects: Fluorescent polymers , Polymerization
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: vital:10440 , http://hdl.handle.net/10948/d1020798
- Description: In this study, fluorescent polymers with pendant quinoline groups were synthesized by reversible addition-fragmentation chain transfer polymerization (RAFT) from a fluorescent quinoline-based vinyl monomer, synthesized in multiple steps from p-nitroaniline and crotonaldehyde. The structures of the synthesized vinyl monomer and polymers were confirmed by NMR and FT-IR spectroscopy, X-ray studies and modeling stdies. The photophysical properties of the synthesized quinoline compounds and resulting polymers were investigated. In order to evaluate the binding potential of our quinoline-based polymer in the presence of transition metal ions, preliminary studies on a complexation of quinoline-based polymers with Zn, Cd, Hg, Fe, and Ni were carried out. The investigation of fluorescence properties of the complexes showed fluorescence quenching for Fe(II), and fluorescence enhancement for the remaining ions [Zn(II), Cd(II), Hg(II), and Ni(II)].
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- Date Issued: 2014
An analysis of teacher's skills in the identification of learners with behavioural and emotional problems
- Authors: Damons, Thirza
- Date: 2013
- Subjects: Teachers -- Training of , Interaction analysis in education , Observation (Educational method)
- Language: English
- Type: Thesis , Masters , MEd
- Identifier: vital:9451 , http://hdl.handle.net/10948/d1012183 , Teachers -- Training of , Interaction analysis in education , Observation (Educational method)
- Description: This study aimed to explore teachers‟ abilities to identify learners with behavioural and emotional problems, to examine the strategies that they implement to address the challenges and their measure of success in addressing these. This study was qualitative in nature and semi-structured interviews were conducted with 10 volunteer teachers located in the northern areas of Port Elizabeth and an additional 50 teachers completed open ended questionnaires. The learning areas taught by the teachers varied. Descriptive and content analysis procedures were utilized to analyze the findings. The findings indicated that teachers lack the skills and knowledge to assist learners with behavioural and emotional problems. The teachers tended to view their roles as imparting knowledge rather than tending to the mental health of learners so they did not adopt approaches to assist the learners with their behavioural and emotional challenges. This was in spite of the fact that the learners' psychological and physical well-being impacted their academic achievement.
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- Date Issued: 2013
Investigating variables that have impact on annual financial statement audit report outcomes in local government
- Authors: Sigcau, Ntsikelelo
- Date: 2013
- Subjects: Local finance -- South Africa -- Auditing , Finance, Public -- South Africa , Local government -- South Africa -- Finance
- Language: English
- Type: Thesis , Masters , MBA
- Identifier: vital:8906 , http://hdl.handle.net/10948/d1021004
- Description: The third sphere of government (Local Government) has been persistently clouded by unfavourable Annual Financial Statement (AFS) audit reports. This results in local government losing credibility and its stakeholders losing confidence in the institutions or municipalities. In-depth analysis of the root cause of this dilemma is an opportunity for the municipality to reorganise its house and redeem its dignity and credibility to its stakeholders through addressing the identified challenges. The importance of the study can be attributed to the need to investigate the root causes of unfavourable audit opinion and recommend possible remedies that can assist municipalities to improve their audit report outcomes which in turn will improve the confidence of its stakeholders. The primary objective of the study was to investigate variables that impact on the audit report outcomes on annual financial statements of the municipalities that are within Alfred Nzo District (AND) Jurisdiction, including Alfred Nzo District Municipality (ANDM). This was achieved through investigating the root causes of the audit report outcomes with specific focus on the relationship that exists between the management role and audit outcomes of the Alfred Nzo District Municipalities. This was measured by the municipality’s leadership, governance, internal controls and human capital management. Convenient sampling was used wherein 150 questionnaires (30 per municipality) were sent out to the selected employees in all the municipalities in the Alfred Nzo District. Out of the questionnaires that were sent out, 103 responses were received. These were analysed to draw findings, conclusion and recommendations. The empirical results of the study revealed that there is strong evidence that leadership, governance and human capital management have a positive influence on the municipality’s AFS audit report outcomes. It also revealed that there is overwhelming evidence that internal controls have a positive influence on the municipality’s AFS audit report outcomes. The study recommends how leadership, governance, internal controls and human capital management must be improved. It also provides future research recommendations to improve this study.
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- Date Issued: 2013
Barriers to entrepreneurship: assessing NMBM school leavers for business enterprise
- Authors: Qumza, Thabang Vuyo
- Date: 2011
- Subjects: Young adults -- Employment -- South Africa -- Eastern Cape , Youth development -- South Africa , Entrepreneurship -- South Africa -- Eastern Cape
- Language: English
- Type: Thesis , Masters , MBA
- Identifier: vital:8943 , http://hdl.handle.net/10948/d1011804 , Young adults -- Employment -- South Africa -- Eastern Cape , Youth development -- South Africa , Entrepreneurship -- South Africa -- Eastern Cape
- Description: In plight of the country‟s high unemployment, poverty, and income inequalities, there is an urgent need to address these issues by converging toward entrepreneurship. World-wide, it is acknowledged by both government and academia that entrepreneurship soothes and remedies socio-economic ills. It creates employment, wealth, alleviates poverty, increases tax base, balances income disparities and accomplishes social stability. With the high youth (18-34 year age) unemployment looming at 73 percent and a low South African total entrepreneurship rate at 8.9 percent; this study attempts to investigate the barriers that hinder school leavers from engaging in entrepreneurship. The research investigates critical entrepreneurial factors including entrepreneurial character and behaviour, entrepreneurial knowledge and skills, managerial knowledge and skills, knowledge on legal aspects of a business, sourcing of finances, and entrepreneurial background and orientation. The primary objective was met through the investigation of the secondary objectives. This was accomplished through a questionnaire survey, composed with multiple choice questions and closed questions measured on a Likert scale. The questionnaire was constructed based on the literature reviewed from various sources including books, dissertations, journals, government reports, newspapers, magazines, internet, television and radio broadcasts (interviews and news). The study discovers that learners are inhibited by various factors from engaging into business venturing. The list of barriers identified was: A discouraging entrepreneurial background (heritage) – parents had low levels of education and were not entrepreneurial, Weak entrepreneurial character and behaviour, Lack of entrepreneurial exposure and work experience, Learners lack financial skills and computer skills, Families lack savings to financially support their business start-ups, Limited knowledge on the legal aspects regulating a business, Limited knowledge on sourcing finances (angel and venture capital investors).
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- Date Issued: 2011