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药品生产投料现状及对策研究

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目前,制药企业生产药品时可能存在低限投料和过量投料的情况.低限投料是指在生产过程中使用的原材料数量低于最低要求;过量投料是指在生产过程中投料所用原料药的数量超过按配方要求投料量的100%以上.药品生产中,低限投料和过量投料均会对药品质量和安全性产生影响.低限投料可能导致药品的有效性和稳定性降低,过量投料则可能导致原材料的浪费和过量使用,增加生产成本,并可能对药品的质量和安全性造成风险.因此,需要制药企业、监管部门、社会公众三方合力保障药品的质量和使用安全.本研究在梳理药品生产投料现状的基础上,分析了影响药品投料限度的因素,包括药物成分、稳定性、制造工艺、质量控制和法规要求等,并讨论了低限投料和过量投料的原因、影响等,提出了制药企业和监管部门在药品生产投料限度控制方面的具体对策和建议,建议制定有效提高药品生产质量及管理水平科学的优化措施,为各相关主体保障用药安全、提升监管能力提供参考方向.
Research on the Current Situation and Countermeasures of Row Material Feeding in Pharmaceutical Production
At present,there may be some cases of low-limit and over-dose row material feeding in pharmaceutical production.Low-limit row material feeding means that the quantity of raw materials used in the production process is lower than the minimum requirement.Over-dose row material feeding is defined as the quantity of raw materials used in the production process exceeding 100%of the dosage required by the formula.In pharmaceutical production,the quality and safety of pharmaceutical products may be affected by both low-limit and over-dose row material feeding.low-limit row material feeding may lead to reduced effectiveness and stability of the pharmaceu-tical products,while over-dose row material feeding may lead to waste and overuse of raw materials,increase production costs and may pose risks to the quality and safety of pharmaceutical products.Therefore,it is necessary for pharmaceutical enterprises,regulatory agen-cies,and the public to work together to ensure the quality and safety of pharmaceutical products.On the basis of combing the current situ-ation of row material feeding in pharmaceutical production,this study analyzed the factors that affect the limit of row material feeding,including drug components,stability,manufacturing processes,quality control,and regulatory requirements,discussed the reasons and impacts of low-limit and over-dose row material feeding,and proposed specific measures and suggestions for pharmaceutical enterprises and regulatory authorities to control the limit of row material feeding in pharmaceutical production.It is suggested to formulate scientific optimization measures to effectively improve the quality of pharmaceutical production and management level.This study provides refer-ence for relevant subjects to ensure drug safety and improve supervision ability.

Pharmaceutical productionFeeding limits of row materialsCountermeasuresMedication safety

宁雪

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长春市食品药品检验中心,吉林 长春 130000

药品生产 投料限度 对策 用药安全

2024

中国医药导刊
国家食品药品监督管理局信息中心

中国医药导刊

影响因子:1.408
ISSN:1009-0959
年,卷(期):2024.26(4)
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