Uche, Chidi; Ekeocha, Z; Byrn, S; and Clase, K, "Retrospective Study of Inspectors Competency in the Act of Writing GMP Inspection Report" (2021). BIRS Africa Technical Reports. Paper 13.
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Regulatory system, good manufacturing practice, pharmaceutical inspectors, inspectional observation., inspection report, compliance letter
The research was a retrospective study of twenty-five Good Manufacturing Practice (GMP) inspection reports (from March 2017 through to December 2018) of a national medicine regulatory agency, drug Inspectorate, in West Africa, designed to assess the inspectors’ expertise in the act of inspection report writing. The investigation examined a paper-based tool of thirteen pre-registration Inspection reports and twelve GMP reassessment reports written prior and following an intervention program by external GMP trainers to enhance inspectors’ skill in pharmaceutical cGMP inspection. The study made use of quantitative analysis to investigate each team’s expertise in the act of writing GMP inspection report. Likewise, each report’s compliance with the requirements of three regulatory standards on GMP inspection report writing was ascertained. Impact of intervention program on lead inspectors’ competence was assessed. Lastly, gap in each team writing effectiveness, and lead inspectors’ abilities to deliver an effective report were determined. The results showed one of the inspection team (4.0%) wrote an excellent report. Two (8.0%) of the twenty-five inspection teams penned good inspection reports. Eleven (44.0%) teams drafted needs improvement reports and the remaining eleven teams (44.0%) prepared unacceptable reports. The excellent report and the two good reports had report format that meet expectation. One (50.0%) of the good reports showed the authors possess excellent knowledge of cGMP technical areas. The remain good report (50.0%) revealed the writers’ knowledge.as good. The excellent report showed the authors displayed partial mastery in the use of objective evidence while the two good reports disclosed theirs as having partial and evolving abilities. One of the teams (50.0%) that wrote good reports displayed good use of third person narrative past tense in report writing whereas the other team used the same tense and voice excellently. Generally, a sort of marginal level of performance was prominent among the inspection teams. A gap, if not tackled, will slow down regulatory process through increase report review, litigations that query report factual accuracy (AIHO, 2017) and delay in issuance of marketing authorization. In conclusion, trainings on quality attributes, such as technical content (Quality Management System (QMS) and Site), the use of objective evidence, assignment of risk levels to GMP violations and citing of applicable laws, regulation and guidelines that substantiate GMP observations, were recommended, to enhance knowledge sharing and regulators’ performance in the act of writing inspection report.