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  11. Good Manufacturing Practice Inspections Conducted By Tanzania Medicines And Medical Devices Authority: A Comparative Study Of Two Fiscal Years From 2018 To 2020

Good manufacturing practice inspections conducted by Tanzania medicines and medical devices authority: a comparative study of two fiscal years from 2018 to 2020

Raphael Zozimus Sangeda1, Chimpaye Julius Ndabatinya2, Maganga Bundala Maganga2

  • 1Department of Pharmaceutical Microbiology, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.

Journal of Pharmaceutical Policy and Practice
|September 18, 2024

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View abstract on PubMed

Summary
This summary is machine-generated.

Pharmaceutical facilities showed a significant decline in Good Manufacturing Practices (GMP) conformance, dropping from 50% to 32.9%. This highlights the need for continued GMP inspections and corrective actions, especially considering pandemic impacts.

Area of Science:

  • Pharmaceutical Quality Assurance
  • Regulatory Compliance
  • Drug Manufacturing Standards

Background:

  • Good Manufacturing Practices (GMP) are essential for pharmaceutical quality assurance, ensuring consistent product quality.
  • This study evaluated GMP conformance in pharmaceutical facilities over two fiscal years (2018/2019 and 2019/2020).
  • The East African GMP Compendium (2014) served as the benchmark for assessing conformance.

Purpose of the Study:

  • To compare GMP conformance rates of pharmaceutical facilities between 2018/2019 and 2019/2020.
  • To identify common areas of non-conformance in pharmaceutical manufacturing.
  • To assess the impact of external factors, such as the COVID-19 pandemic, on GMP compliance.

Main Methods:

  • Analysis of conformance proportions for foreign pharmaceutical industries against GMP standards.
Keywords:
Good manufacturing practice (GMP) inspectionsTanzania Medicines and Medical Devices Authority (TMDA)and efficacy

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  • Aggregated data reporting over a two-year period.
  • Utilized the East African GMP Compendium as a quality standard benchmark.

    • Main Results:

    • Facilities exhibited significant non-conformances, particularly in laboratory quality control and premises.
    • A downward trend in GMP conformance was observed in 2019/2020 (32.9%) compared to 2018/2019 (50%).
    • The COVID-19 pandemic potentially impacted on-site inspections and contributed to lower conformance rates.

    Conclusions:

    • Continued GMP inspections and corrective actions are vital for ensuring product quality in Tanzania.
    • Desk reviews are valuable tools for regulatory authorities, especially during unforeseen challenges like pandemics.
    • Maintaining high GMP standards is crucial for pharmaceuticals marketed in Tanzania.
    assessment and registration of medicinal products
    post-market surveillance
    quality
    regulation of medicines
    safety