Full
Outline
Package integrity, which is synonymous with container-closure integrity, is the ability of a package to maintain product quality, including preventing microorganism ingress and ensuring that the product meets all necessary safety and quality requirement. Package integrity assessment begins at the product development phase and continues throughout the product life cycle, which is a key consideration in the manufacturing, quality research and evaluation of sterile products. This article mainly refers to the US Pharmacopeia (USP) 〈1207〉 guidelines, based on the understanding of CMC review experience, introduces and discusses the content of container-closure integrity, including concepts and scope, the requirements of different product life cycles, testing methods and validation, etc. It is hoped that the content of this article will provide some references for the quality study and evaluation of sterile pharmaceutical products.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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