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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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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