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Abstract Background National Medicines Regulatory Authorities like the Pharmacy Board of Sierra Leone are responsible for protecting and promoting public health, implementing regulatory standards, and maintaining a supply chain with an assured supply of medical products that are safe, effective, and of good quality. This retrospective study assesses the identification of substandard and falsified medicines, the changes in the functions and key indicators of assessment, and the quality improvement changes of the Pharmacy Board of Sierra Leone. Methods Data was obtained from 2013 to 2021 records using a data collection tool to collate and review all relevant information to 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. The review also included, identified substandard and falsified medicines, the World Health Organisation Global benchmarking self-assessment tool, and internal and external audit records of the quality management system of all twelve departments of the Pharmacy Board of Sierra Leone. Results The study showed marked changes in identifying substandard and falsified medicines by the Pharmacy Board of Sierra Leone during ISO 9001:2015 implementation (2017- 2020) compared to Pre-ISO 9001:2015 implementation (2013- 2016). Critical functions of the Pharmacy Board of Sierra Leone from the assessment of the WHO GBT ML in 2016 and 2021 showed that several indicators had been addressed during ISO 9001:2015 certification with improvement in the level of maturity for the quality management systems and Pharmacovigilance functions. There was also an improvement in identifying non-conformances and a commitment to continuous improvement of processes during ISO 9001:2015 implementation. Conclusions This study revealed that regular checks through standard assessment, internal audits, and standard management review processes that generate follow-up actions, timelines, and a commitment to identifying correction, and corrective actions for non-conformances are essential quality improvement tools for the efficient functioning of an institution (Pharmacy Board of Sierra Leone). Our study revealed that commitment to continuous implementation of proper quality management system could significantly improve institutional efficiency, thereby improving service delivery and customer satisfaction.

Paracetamol is a widely used over-the-counter drug for managing fever and pain, but its quality may vary among different brands, especially in low- and middle-income countries, where counterfeit and substandard medicines are prevalent. This study evaluated the physicochemical properties of fifteen brands of 500 mg paracetamol tablets sold in various pharmacies in Freetown, Sierra Leone using identification tests, friability tests, assay, dissolution tests, and mass variation.The results showed that three brands were not registered with the Pharmacy Board of Sierra Leone, and two brands did not meet the requirement for labelling (no manufacturing date). All the brands met the requirement for mass variation, friability tests and assays. The percentage assay of the different brands ranged from 96.17 %w/w to 101.97 %w/w. However, two brands did not meet the specification for dissolution, with P012 releasing about 21.23 % ± 5.76 of the drug within 45min.Most of the paracetamol brands evaluated met the physicochemical test specification. However, two brands failed the dissolution test, two brands did not meet the labelling requirement and three brands were identified as unregistered products with the National Medicines Regulatory Authority in Sierra Leone. This study underscores the necessity of enhancing monitoring and post-market surveillance of pharmaceuticals in Sierra Leone to ensure they comply with regulatory requirements.