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Good Manufacturing Practice Inspections Conducted by Tanzania Medicines and Medical Devices Authority: a Comparative Study of Two Fiscal Years from 2018 to 2020

Overview
Journal J Pharm Policy Pract
Date 2024 Sep 18
PMID 39291054
Authors
Raphael Zozimus Sangeda
Chimpaye Julius Ndabatinya
Maganga Bundala Maganga
Emmanuel Alphonce Nkiligi
Yonah Hebron Mwalwisi
Adam Mitangu Fimbo
Affiliations
Soon will be listed here.
Abstract

Background: Good Manufacturing Practices (GMP) is the bedrock of quality assurance in the pharmaceutical industry that ensures that products are consistently produced and controlled according to quality standards. This study compared the GMP conformance of pharmaceutical facilities across two fiscal years, 2018/2019 and 2019/2020, using the East African GMP Compendium on Good Manufacturing Practices, 2014, as a benchmark.

Methods: We analyzed the proportion of conformance of foreign pharmaceutical industries to GMP standards and reported the aggregated data over a two-year period.

Results: Inspected facilities had notable non-conformances, most commonly related to laboratory quality control and premises. We noted a downward trend in conformance in 2019/2020 compared with 2018/2019, with only 32.9% of facilities adhering to EAC GMP requirements, down from 50% in the previous year. The COVID-19 pandemic has affected the ability to conduct on-site inspections, and may have contributed to the lower conformance rate.

Conclusions: These findings underscore the crucial need to continue GMP inspections and the importance of taking corrective actions to ensure adherence to the quality standards for products marketed in Tanzania. The study further revealed the significance of desk reviews in assisting regulatory authorities in facing unforeseen challenges such as pandemics.

References
1.
Diak I, Swank K, McCartan K, Beganovic M, Kidd J, Gada N . The Food and Drug Administration's (FDA's) Drug Safety Surveillance During the COVID-19 Pandemic. Drug Saf. 2022; 46(2):145-155. PMC: 9718450. DOI: 10.1007/s40264-022-01256-2. View
2.
Sithole T, Mahlangu G, Capote V, Sitoie T, Shifotoka S, Gaeseb J . Evaluation of the Good Review Practices of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward. Front Med (Lausanne). 2021; 8:742181. PMC: 8429788. DOI: 10.3389/fmed.2021.742181. View
3.
Mujinja P, Mackintosh M, Justin-Temu M, Wuyts M . Local production of pharmaceuticals in Africa and access to essential medicines: 'urban bias' in access to imported medicines in Tanzania and its policy implications. Global Health. 2014; 10:12. PMC: 4021829. DOI: 10.1186/1744-8603-10-12. View
4.
Covarrubias C, Rivera T, Soto C, Deeks T, Kalergis A . Current GMP standards for the production of vaccines and antibodies: An overview. Front Public Health. 2023; 10:1021905. PMC: 9891391. DOI: 10.3389/fpubh.2022.1021905. View
5.
Bjerke L . Antibiotic geographies and access to medicines: Tracing the role of India's pharmaceutical industry in global trade. Soc Sci Med. 2022; 312:115386. PMC: 9489990. DOI: 10.1016/j.socscimed.2022.115386. View