Prosedur Penarikan Produk dan Pengelolaan Produk Kembalian dalam Rantai Distribusi Farmasi

Authors

  • Niken Widya Ningrum Universitas Muhammadiyah Banjarmasin
  • Nur Latipah Sulistiawanti Universitas Muhammadiyah Banjarmasin
  • Nor Latifah Universitas Muhammadiyah Banjarmasin

DOI:

https://doi.org/10.59841/an-najat.v3i3.3107

Keywords:

returned products, drug recall, product quality, regulation, pharmaceutical distribution

Abstract

Product recall and returned product management are essential in ensuring the quality, safety, and efficacy of pharmaceutical preparations in circulation. Data were obtained from various journals and official reports from 2018 to 2024 relevant to pharmaceutical recalls. With effective recall mechanisms, customer safety and quality of pharmaceutical services are anticipated to enhance continuously. This review highlights the significance of strengthening effective recall systems, human resource training, and the use of digital technology in distribution processes. This article aims to thoroughly examine the procedures for product recall and returned product management within the pharmaceutical distribution chain through a literature study. The review shows that despite the availability of national and international regulations, implementation still faces difficulties such as absence of unified information systems, insufficient collaboration among industry players and authorities, and less than optimal quality culture in the field. Additionally, difficulties in product tracking, documentation, and recall decision-making are also concerns.

References

Ball, G. P., Shah, R., & Donohue, K. (2018). The decision to recall: A behavioral investigation in the medical device industry. Journal of Operations Management, 62, 1-15.

BPOM. 2011. Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor 04 Tahun 2011 Tentang Kriteria dan Tata Cara Penarikan Obat yang Tidak Memenuhi Standar dan/atau Persyaratan. Jakarta: BPOM RI.

Dharmesh, B., Venkatesh, M. P., dan Kumar, T. M. P. 2018. Pharmaceutical Product Recall in USA and EU: Comparative analysis. International Journal of Pharmaceutical and Clinical Research. 10(4): 102-106.

Eissa, M. E. 2019. Drug Recall Monitoring and Trend Analysis: A Multidimensional Study. Global Journal on Quality and Safety in Healthcare. 2(2): 34-39.

Harsanti, B. D., & Chaerunisaa, A. Y. (2021). Review Artikel: Manajemen Risiko Mutu, Metode Serta Penerapannya Dalam Industri Farmasi. Farmaka, 19(1), 77-88.

Hosseini-Motlagh, S. M., Jazinaninejad, M., & Nami, N. (2023). Recall management in pharmaceutical industry through supply chain coordination. Annals of Operations Research, 1-39.

Kalidindi, V. R., Durga, B. M. S., & Nori, L. P. (2024). From Risk to Resilience: Uncovering Drug Recall Trends and Bolstering Safety Strategies. Ind. J. Pharm. Edu. Res, 58(4), 1015-1033.

Lestari, P., & Santoso, B. (2020). Penerapan Good Distribution Practices (GDP) dalam Menjamin Mutu Produk Farmasi. Jurnal Distribusi Farmasi, 4(1), 15-22.

Mudin, N. (2018). Penjaminan Mutu dalam Pendistribusian Sediaan Farmasi. Majalah Farmasetika, 3(1), 1-6.

Nugroho, A., et al. (2021). Audit Internal dan Pengaruhnya terhadap Pengendalian Recall Produk Farmasi. Jurnal Farmasi Klinik, 9(2), 98-105.

Prasetyo, A., et al. (2019). Evaluasi Sistem Pengelolaan Produk Kembalian di Industri Farmasi. Jurnal Teknologi Farmasi, 11(4), 150-157.

Putri, D. A., & Hidayat, R. (2021). Implementasi Reverse Logistics pada Pengelolaan Produk Farmasi. Jurnal Logistik dan Distribusi, 3(2), 89-98.

Rahmawati, N., et al. (2022). Kendala Pelaksanaan Recall Produk Obat di Indonesia. Jurnal Kesehatan Masyarakat, 16(1), 30-38.

Sari, R. P., & Nurhadi, B. (2020). Analisis Faktor Penyebab Recall Produk Farmasi di Indonesia. Jurnal Farmasi Sains dan Praktik, 5(1), 45-53.

Surbakti, C. I., Waruwu, S. B., & Tampubolon, M. I. (2023). EVALUASI PROTAP RECALL DI PEDAGANG BESAR FARMASI PT. MILLENNIUM PHARMACON INTERATIONAL TBK CABANG MEDAN. JURNAL FARMANESIA, 10(1), 31-33.

Wandita, G. A., TRISTI, J., SAKINAH, A. R., & SINURAYA, R. K. (2020). Studi Komparatif Peraturan Penarikan Produk Obat di India dan Inggris. Farmaka, 18(2), 105-114.

Downloads

Published

2025-07-12

How to Cite

Niken Widya Ningrum, Nur Latipah Sulistiawanti, & Nor Latifah. (2025). Prosedur Penarikan Produk dan Pengelolaan Produk Kembalian dalam Rantai Distribusi Farmasi . An-Najat, 3(3), 52–62. https://doi.org/10.59841/an-najat.v3i3.3107

Similar Articles

1 2 3 4 5 6 7 > >> 

You may also start an advanced similarity search for this article.

Most read articles by the same author(s)