Agu, Monica; Ekeocha, Z; Byrn, S; and Clase, K, "The Impact of Mentoring as a GMP Capability Building Tool in The Pharmaceutical Manufacturing Industry in Nigeria" (2021). BIRS Africa Technical Report Papers. Paper 15.
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Date of this Version
Mentoring, mentoring program effectiveness, capability building, mentor
Good Manufacturing Practices (GMP), a component of Pharmaceutical Quality Systems, is aimed primarily at managing and minimizing the risks inherent in pharmaceutical manufacture to ensure the quality, safety and efficacy of products. Provision of adequate number of personnel with the necessary qualifications/practical experience and their continuous training and evaluation of effectiveness of the training is the responsibility of the manufacturer. (World Health Organization [WHO], 2014; International Organization for Standardization [ISO], 2015). The classroom method of training that has been used for GMP capacity building in the pharmaceutical manufacturing industry in Nigeria over the years, delivered by experts from stringently regulated markets, have not yielded commensurate improvement in the Quality Management Systems (QMS) in the industry. It is necessary and long over-due to explore an alternative training method that has a track record of success in other sectors. A lot of studies carried out on mentoring as a development tool in several fields such as academia, medicine, business, research etc., reported positive outcomes. The aim of this study was to explore mentoring as an alternative GMP training method in the pharmaceutical manufacturing industry in Nigeria. Specifically, the aim of this study was to evaluate the impact of mentoring as a GMP capability building tool in the pharmaceutical manufacturing industry in Nigeria, with focus on GMP documentations in XYZ pharmaceutical manufacturing company located in South-Western region of Nigeria. The methodology comprised gap assessment of GMP documentation of XYZ company to generate current state data, development of training materials based on the identified gaps and use of the training materials for the mentoring sessions. The outcome of the study was outstanding as gap assessment identified the areas of need that enabled development efforts to be targeted at these areas, unlike generic classroom training. The mentees’ acceptance of the mentoring support was evident by their request for additional training in some other areas related to the microbiology operations that were not covered in the gap assessment. This result portrays mentoring as a promising tool for GMP capacity building, but more structured studies need to be conducted in this area to generate results that can be generalized.