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企业特征与日本膳食补充剂良好生产规范采用情况。

Corporate Characteristics and Adoption of Good Manufacturing Practice for Dietary Supplements in Japan.

机构信息

Department of Innovation Science, School of Environment and Society, Tokyo Institute of Technology, Tokyo 108-0023, Japan.

Graduate School of Technology Management, Ritsumeikan University, Osaka 567-8570, Japan.

出版信息

Int J Environ Res Public Health. 2020 Jul 1;17(13):4748. doi: 10.3390/ijerph17134748.

Abstract

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, = 0.019), possession of a manufacturing license for pharmaceutical products (13.7, = 0.003), and number of own product categories manufactured (3.93, = 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.

摘要

良好生产规范(GMP)被提倡并实施为制造膳食补充剂的标准化程序。然而,在日本作为一个案例,到目前为止,该领域只有一半的制造商采用它。为了解决这个问题,本研究旨在探讨公司的关键特征对采用和遵守膳食补充剂 GMP 的影响。重点是制药行业专业知识的影响。分析了日本膳食补充剂行业 90 家制造商的公司特征与 GMP 采用之间的关系。二项逻辑回归分析表明,以下三个因素中的每一个都对公司采用 GMP 具有积极和显著的影响:收入方面的公司规模(优势比=1.04,=0.019)、拥有药品生产许可证(13.7,=0.003)和制造的自有产品类别数量(3.93,=0.00009)。这些发现强烈表明,公司生产药品的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因素。对 GMP 的采用和实施条件考虑甚少。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形成理论基础,在经验上做出了贡献。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2a8b/7370077/138e214d1bf3/ijerph-17-04748-g001.jpg

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