- Title
- Compliance with good distribution practice guidelines for cold chain products among pharmaceutical wholesalers in South Africa
- Creator
- Masebe, Zandisile
- Subject
- Pharmaceutical industry
- Date Issued
- 2020
- Date
- 2020
- Type
- Thesis
- Type
- Masters
- Type
- MPharm
- Identifier
- http://hdl.handle.net/10948/46390
- Identifier
- vital:39581
- Description
- Background: The South African pharmaceutical cold chain distribution industry is highly regulated. Cold chain pharmaceutical products require storage in a cold room, in a temperature-controlled environment between (2°C-8°C) and the cold chain must be maintained at all times throughout the distribution process. The incorrect handling, storage, transport and distribution of cold chain products may reduce the potency and therapeutic effectiveness of the product which in turn may result in treatment failure. The research was aimed at determining the level of compliance to current Good Distribution Practice guidelines for cold chain products among pharmaceutical wholesalers and distributors in South Africa. Methodology: The study made use of quantitative research techniques. A purpose designed online questionnaire was used as a data collection tool from the study participants. The judgmental sampling technique was used in this study as it was found to be the most appropriate method for the research question. Phase one of the study was to conduct a pilot study at two Port Elizabeth pharmaceutical wholesalers. The data was analysed using Microsoft Excel®, chi-square test for goodness of fit and content analysis. The data was further analysed using a descriptive and inferential statistics approach to determine the level of compliance to regulatory guidelines for cold chain products.Results:The results obtained from the empirical study revealed that less than 50% of the study respondents indicated compliance to the factors listed in the regulatory guidelines for cold chain products distribution.These factors include cold chain monitoring, alternative power sources, validation of cold chain boxes and route transport validation.Conclusion:The wholesale pharmaceutical industry is experiencing challenges to comply with factors necessary to ensure compliance with GDP guidelines for cold chain products. Through the study it was proven that there is evidence of commitment by the industry to implement the GWP and GPP amendment guidelines, despite less than 50% of the respondents reporting compliance to the guidelines. Recommendations were provided to improve the level of compliance to guidelines for cold chain products by pharmaceutical wholesalers in South Africa.
- Format
- xix, 100 leaves
- Format
- Publisher
- Nelson Mandela University
- Publisher
- Faculty of Health Sciences
- Language
- English
- Rights
- Nelson Mandela University
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| Thumbnail | File | Description | Size | Format | |||
|---|---|---|---|---|---|---|---|
| View Details Download | SOURCE1 | Masebe, AR 197412640 Treatise April 2020.pdf | 1 MB | Adobe Acrobat PDF | View Details Download |