Corporate Characteristics and Adoption of Good Manufacturing Practice for Dietary Supplements in Japan
Corporate Characteristics and Adoption of Good Manufacturing Practice for Dietary Supplements in Japan
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DOI：
10.3390/ijerph17134748
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发表时间：
2020-07-01
影响因子：
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通讯作者：
Sengoku, Shintaro
中科院分区：
文献类型：
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作者：
Sato, Keigo;Kodama, Kota;Sengoku, Shintaro
良好生产规范 (GMP) 作为膳食补充剂生产的标准化程序得到提倡和实施。但以日本为例，目前该领域仅有一半厂商采用。为了解决这个问题，本研究旨在探讨公司的关键特征对膳食补充剂 GMP 的采用和遵守的影响。重点是制药行业专业知识的影响。对日本膳食补充剂行业的 90 家制造商进行了公司特征与 GMP 采用之间的关系分析。二项式逻辑回归分析显示，以下三个因素对公司采用 GMP 具有积极且显着的影响：公司收入规模（比值比 = 1.04，p = 0.019）、拥有药品生产许可证（13.7，p = 0.003）以及生产的自有产品类别数量（3.93，p = 0.00009）。这些发现强烈表明，该公司的药品制造能力是日本膳食补充剂行业更好地采用质量标准的关键驱动力。很少考虑 GMP 的采用和实施条件。本研究通过为膳食补充剂行业的问题提供关键线索并为政策制定者和监管机构奠定理论基础，在实证上做出了贡献。
Good manufacturing practice (GMP) is advocated and implemented as a standardized procedure for manufacturing dietary supplements. However, in Japan as a case, only half of the manufacturers in this field so far adopt it. To address this issue, the present study aims to explore the effect of key characteristics of a company on the adoption of and compliance with GMP for dietary supplements. The focus is on the effect of expertise in the pharmaceutical industry. The relationships between company characteristics and the adoption of GMP were analyzed for 90 manufacturers in the dietary supplement industry in Japan. A binomial logistic regression analysis showed that each of the following three factors had a positive and significant effect on the company's adoption of GMP: company size in terms of revenue (odds ratio = 1.04, p= 0.019), possession of a manufacturing license for pharmaceutical products (13.7, p= 0.003), and number of own product categories manufactured (3.93, p= 0.00009). These findings strongly suggest that the company's manufacturing capability of pharmaceutical products works as a key driver for the better adoption of a quality standard in the dietary supplement industry in Japan. Few considerations were made for conditions of the adoption and implementation of GMP. The present study empirically contributes by providing key clues for issues in the dietary supplement industry and by forming a theoretical base for policymakers and the regulatory authorities.