药品生产过程中是否是百分百灯检？欧洲药典有没有这方面的要求？
生产管理
2019-02-13 10:01 lily熙熙     
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欧洲药典  5.17.2章节由明确规定：

INSPECTION SCHEMES
Each container of a liquid preparation (e.g. vial, syringe, ampoule) is visually inspected after filling and closure.

2024-08-26 09:44 齐御风     
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ChP2025新增指导原则 关于9016注射剂可见异物控制指导原则标准草案的公示（第二次）（2024-08-15~2024-09-15）中提到了生产过程100%检查。

2024-08-19 12:37 匿名     
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关于100%灯检，中国GMP2010版 无菌药品附录第七十九条也有规定：应当逐一对无菌药品的外部污染或其他缺陷进行检查。如采用灯检法.......;

欧洲药典，USP、欧盟GMP附录1等，都有100%灯检要求，这个要求已经有很多年了

2024-08-16 17:43 Sumei     
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欧洲药典可见异物章节是有100%灯检要求的，是在药典后面的章节，美国药典直接是在USP790说明的100%灯检

2024-08-02 08:35 Lihli     
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1、欧洲药典5.17.2 Recommentdattions on testing of particulate contamination：visible particles


2、EU GMP Annex 1 Manufacture of Sterile Medicinal Products
附录1 无菌药品生产
EU | 2022-08-22

https://lib.shilinx.com:443/u/xm4wcq

8.30 All filled containers of parenteral products should be inspected individually for extraneous contamination or other defects. Defect classification and criticality should be determined during qualification and based on risk and historical knowledge. Factors to consider include, but are not limited to, the potential impact of the defect to the patient and the route of administration. Different defect types should be categorized and batch performance analysed. Batches with unusual levels of defects, when compared with routine defect numbers for the process (based on routine and trend data), should be investigated. A defect library should be generated and maintained which captures all known classes of defects. The defect library should be used for the training of production and quality assurance personnel. Critical defects should not be identified during any subsequent sampling and inspection of acceptable containers. Any critical defect identified subsequently should trigger an investigation as it indicates a possible failure of the original inspection process.

2024-08-01 17:06 沐清风     
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124. Filled containers of parenteral products should be inspected individually for extraneous contamination or other defects. When inspection is done visually, it should be done under suitable and controlled conditions of illumination and background. Operators doing the inspection should pass regular eye-sight checks, with spectacles if worn, and be allowed frequent breaks from inspection. Where other methods of inspection are used, the process should be validated and the performance of the equipment checked at intervals. Results should be recorded.

欧盟GMP Annex 1 征求意见稿 - 2017/12/20

Finishing of sterile products 

8.18 Containers should be closed by appropriately validated methods. Containers closed by fusion, e.g. Form-Fill-Seal Small Volume Parenteral (SVP) & Large Volume Parenteral (LVP) bags, glass or plastic ampoules, should be subject to 100% integrity testing. Samples of other containers should be checked for integrity utilising validated methods and in accordance with QRM, the frequency of testing should be based on the knowledge and experience of the container and closure systems being used. A statistically valid sampling plan should be utilized. It should be noted that visual inspection alone is not considered as an acceptable integrity test method.

8.27 When inspection is done manually, it should be done under suitable and controlled conditions of illumination and background. Inspection rates should be appropriately validated. Operators performing the inspection should undergo robust visual inspection qualification (whilst wearing corrective lenses, if these are normally worn) at least annually. The qualification should be undertaken using appropriate sample sets and taking into consideration worst case scenarios (e.g. inspection time, line speed (where the product is transferred to the operator by a conveyor system), component size or fatigue at the end of shift) and should include consideration of eyesight checks. Operator distractions should be removed and frequent breaks of appropriate duration from inspection should be taken.
2019-02-15 15:58 成龙     
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