答案是可以,如果涉及注册文件,需要按照变更控制进行;
另外,在注册批生产时,尤其是制剂产品,产品的artwork是很有可能无法确定的,因此你说的这种情况是经常出现,建议注册申报时,申报产品的包装类型时只注明到纸盒,另外包装形式变化时,应基于变更的评估,包装材料的变化是否影响到稳定性测试数据,例如:纸盒作为二级包装是否只作为保护性功能,不影响产品的密封性及稳定性,ICH 和WHO相关章节的规定如下:
1、ICH Q1A(R2) Stability Testing of New Drug Substances and Products
2.2.4. Container Closure System
Stability testing should be conducted on the dosage form packaged in the container closure system proposed for marketing (including, as appropriate, any secondary packaging and container label).
2、 WHO 稳定性指南指南 (二级包装提供保护作用,同时标签上明确注明)
2.2.4 Container-closure system
Stability testing should be conducted on the dosage form packaged in the primary container-closure systems proposed for marketing. If the secondary container-closure system has protective properties, and labelling clearly indicates that the product is to be stored in the primary and secondary packaging (e.g. “store tablets in blisters in the provided cartons”), or if the product is packaged in a semi-permeable container where components from the secondary packaging can migrate into the product, the secondary packaging may also form part of the packaging system for stability samples. Any available studies carried out on the FPP outside its immediate container or in other packaging materials can form a useful part of the stress testing of the dosage form or can be considered as supporting information, respectively.
化药可以,但是外包如果具备功能性(避光或其他),需要保证1支/盒的外包功能性≥10支/盒的外包。先看法规↓
(1)化学药物(原料药和制剂)稳定性研究技术指导原则中【稳定性试验的样品应具有代表性......;包装容器也应与商业化生产产品相同或相似。】,需要具有代表性,并没有要求一模一样;
(2)中国药典 四部通则 9001原料药物与制剂稳定性试验指导原则中【(3)加速试验与长期试验所用供试品的包装应与拟上市产品一致。】,“应一致”,也没有说一定需要一致。
从科学角度考虑,稳定性研究的目的就是考察拟上市使用的包装形式是否满足药品贮存的条件,因此通过模拟上市使用包装形式来做稳定性考察。既然是模拟,就可能有偏差,但如果对“偏差”,做了足够的评估,比如稳定性10支/盒,申报和上市让药品住“单间”,但是包装的材料,和功能性都能达到一样的效果,那么稳定性使用10支/盒研究出的数据和结论,就具有代表性,就可以被接受。当然也有可能稳定性研究的条件会更“严苛”,但差异性分析下可接受,同时产品同样能达到预期的质量,那么本次稳定性研究也就具备“代表性”。
——以上拙见,相互交流哦~
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