Quality control in the development of transgenic crop seed products
Quality control in the development of transgenic crop seed products
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DOI：
10.2135/cropsci2001.4151381x
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发表时间：
2001-09-01
期刊：
影响因子：
2.3
通讯作者：
Walters, DS
中科院分区：
文献类型：
--
作者：
Mumm, RH;Walters, DS
鉴于（i）公众对转基因作物安全性的担忧，（ii）食品标签问题，以及（iii）政府对转基因植物的监管，转基因种子产品开发（TSPD）过程的质量控制（QC）监测对于保护研究投资、保持对政府法规的遵守并确保客户满意度至关重要。TSPD中QC监测的主要目标是确保产品检测中使用的种子材料的真实性（转基因事件身份和纯度），以及开发用于政府审查的监管数据包，并开发商业放行的种子量。进行监测以确认推定的转基因事件的存在和所有其他转基因事件的不存在。为监控产品开发过程和保持制造业的质量标准而制定的复杂的QC策略可以作为设计有效策略的基础，以满足种子行业的需求。在TSPD的优化QC监测计划的设计中的一些考虑因素进行了讨论，包括开发和商业化的无缺陷产品的成本与经济效益;有效的检查时间;检查与其他遗传分析的联合调度;检测方法，最大限度地提高筛选效率，灵活性和准确性;抽样与100%的转基因群体的评估;批量样品的能力，以尽量减少数据点的要求;和需要尽量减少或消除检查错误。概述了TSPD的一般过程和玉米（Zea mays L.）提供。
In light of (i) public concern with the safety of genetically modified crops, (ii) the issue of food labeling, and (iii) governmental regulation of transgenic plants, quality control (QC) monitoring of the process of Transgenic Seed Product Development (TSPD) is essential to protecting research investments, maintaining compliance with governmental regulations, and ensuring customer satisfaction. The primary goal of QC monitoring in TSPD is to ensure the authenticity, (transgenic event identity and purity) of seed materials used in product testing, in the development of regulatory data packages for governmental review, and to develop seed volumes for commercial release. Monitoring is performed to confirm the presence of the presumed transgenic event(s) and the absence of all others. Sophisticated QC strategies formulated to monitor the product development process and to maintain quality standards in the manufacturing industry can serve as a foundation in devising efficient strategies tailored to meet needs in the seed industry. A number of considerations in the design of an optimized QC monitoring plan for TSPD are discussed, including-costs vs. economic benefits of developing and commercializing nondefective products; effective timing of inspections; joint scheduling of inspections with other genetic analyses; assay methods that maximize screening efficiency, flexibility, and accuracy; sampling vs. 100% assessment of transgenic populations; the ability to bulk samples to minimize data point requirements; and the need to minimize or eliminate inspection errors. An overview of the general process of TSPD and an example QC monitoring strategy for corn (Zea mays L.) are provided.