Quality Improvement in Medicines Regulation: A Retrospective Analysis of the Pharmacy Board of Sierra Leone pre and post-ISO 9001:2015 Certification era

Abstract

Abstract Background National Medicines Regulatory Authorities like the Pharmacy Board of Sierra Leone are responsible for protecting and promoting public health, implementing rigorous regulatory standards, and maintaining an assured supply of medical products that are safe, effective, and of good quality. This retrospective study assesses the quality improvement of the Pharmacy Board of Sierra Leones’ processes and the influence of internal and external audits on the quality management system and services provided to customers. Methods Data was collected on identified counterfeit drugs from 2013 to 2021 using a data collection tool prepared to collate relevant information that could address the different objectives. All data were sourced from the Department of Quality Assurance and the Department of Enforcement and Narcotics at the Pharmacy Board of Sierra Leone. Internal audit records from 2016 to 2020 and external audit reports from external auditors and the World Health Organisation Global benchmarking self-assessment tool were also used. Results The study showed marked changes in identifying counterfeit drugs by the Pharmacy Board of Sierra Leone post-ISO 9001:2015 certification compared to yearly Pre-ISO 9001:2015 certification. Critical functions of the Pharmacy Board of Sierra Leone from 2016 to 2021 showed that several indicators had been addressed post-ISO9001:2015 certification and an improvement in the level of maturity for the quality assurance (Regulatory systems) and Pharmacovigilance functions. There was also an improvement in addressing the number of identified non-conformances from internal and external audits post-ISO9001:2015 certification. conclusions This study revealed that regular checks through self-assessment, internal audits and standard management review meetings that generate followed up timelines and corrective actions for non-conformances are essential quality improvement tools for the efficient functioning of the Pharmacy Board of Sierra Leone.