Indonesian Journal of Biotechnology
Implementation of Good Distribution Practices for Pharmaceutical Distributors in Indonesia: A Narrative Review
By Debby Febiolla, Teuku Nanda Saifullah Sulaiman and Satibi Satibi.
Abstract
Background: Good Distribution Practices (GDP), governed by the Regulation of the Indonesian FDA (BPOM) No. 6 of 2020, require each facility to implement a quality system that covers responsibilities, processes, and risk management. However, consistent implementation of this framework remains a challenge. According to the 2023 BPOM Annual Report, 632 (81.03%) of 780 inspected pharmaceutical distribution facilities in Indonesia have met regulatory requirements, while 148 (18.97%) have not. No studies have comprehensively synthesized the root causes of non-compliance.Objectives: This study aims to synthesize evidence on GDP implementation at Pharmaceutical Distribution Companies (Pedagang Besar Farmasi/PBF) in Indonesia and to identify key non-compliance areas requiring attention.Methods: A narrative review was conducted by retrieving articles published between 2014 and 2024 from Google Scholar using the following keywords: Evaluation, Implementation, GDP, and Pharmaceutical Distributors. Of the 347 initially identified articles, six met the inclusion criteria after duplicates, non-Indonesian studies, and unrelated topics were excluded.Results: Despite persistent execution inconsistencies, most PBFs demonstrate compliant procurement procedures. Common non-compliance areas include supplier qualification deficiencies, incomplete documentation, inadequate personnel training, improper storage temperature control, and insufficient SOP implementation. Lack of documentation appears in three of six studies (50%), while personnel training deficiencies are reported in four studies (67%).Conclusion: GDP implementation remains uneven across Indonesian pharmaceutical distributors. To ensure sustained GDP compliance, BPOM should increase inspection frequency and impose stricter penalties, PBF managers should conduct internal audits regularly, and responsible pharmacists (Apoteker Penanggung Jawab) should lead periodic staff training and SOP evaluations.




