Shiihi, Solomon; Okafor, U G.; Ekeocha, Z; Byrn, S; and Clase, K, "Improving the Outcome of GMP Inspections by Improving Proficiency of Inspectors through Consistent GMP Trainings" (2021). BIRS Africa Technical Report Papers. Paper 6.
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Date of this Version
Pharmaceutical, checklist, inspection, non-conformances, regulatory, sampling, manufacturing
Approximately 90% of the pharmaceutical inspectors in a pharmacy practice regulatory agency in West Africa have not updated their training on Good Manufacturing Practice (GMP) inspection in at least eight years. However, in the last two years the inspectors relied on learning-on-the job skills. During this time, the agency introduced about 17% of its inspectors to hands-on GMP trainings. GMP is the part of quality assurance that ensures the production or manufacture of medicinal products is consistent in order to control the quality standards appropriate for their intended use as required by the specification of the product. Inspection reports on the Agency’s GMP inspection format in-between 2013 to 2019 across the six geopolitical zones in the country were reviewed retrospectively for gap analysis. Sampling was done in two phases. During the first phase sampling of reports was done by random selection, using a stratified sampling method. In the second phase, inspectors from the Regulatory Agency from different regions were contacted on phone to send in four reports each by email. For those that forwarded four reports, two, were selected. However for those who forwarded one or two, all were considered. Also, the Agency’s inspection format/checklist was compared with the World Health Organization (WHO) GMP checklist and the GMP practice observed. The purpose of this study was to evaluate the reporting skills and the ability of inspectors to interpret findings vis-à-vis their proficiency in inspection activities hence the efficiency of the system. Secondly, the study seeks to establish shortfalls or adequacies of the Agency’s checklist with the aim of reviewing and improving in-line with best global practices. It was observed that different inspectors have different styles and methods of writing reports from the same check-list/inspection format, leading to non-conformances. Interpretations of findings were found to be subjective. However, it was also observed that inspection reports from the few inspectors with the hands-on training in the last two year were more coherent. This indicates that pharmaceutical inspectors need to be trained regularly to increase their knowledge and skills in order to be kept on the same pace. It was also observed that there is a slight deviation in placing sub indicators under the GMP components in the Agency’s GMP inspection format, as compared to the WHO checklist.