关键词: 药品生产, 投料限度, 对策, 用药安全

Abstract:

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 pharmaceutical 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 agencies， and the public to work together to ensure the quality and safety of pharmaceutical products. On the basis of combing the current situation 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 reference for relevant subjects to ensure drug safety and improve supervision ability.

Key words: Pharmaceutical production； , Feeding limits of row materials； , Countermeasures； , Medication safety