有效期、复验期、货架期、使用期限术语 - bjcanny/canny.github.io GitHub Wiki
中国 GMP
复验期：原辅料、包装材料贮存一定时间后，为确保其仍适用于预定用途，由企业确定的需重新检验的日期。
有效期：无定义。有计算有效期的原则。
注：“药品有效期是指药品在一定的贮存条件下，能够保持质量的期限。”这个定义出自颁布 2000 年版药典时的一个附件“关于药品有效期及其规定”。
ICH Q7
Retest Date：The date when a material should be re-examined to ensure that it is still suitable for use.
复验日期：物料应当重新检验以确保其仍可使用的日期。
Expiry Date(or Expiration Date): The date placed on the container/labels of an API designating the time during which the API is expected to remain within established shelf life specifications if stored under defined conditions, and after which it should not be used.
有效期：原料药容器/标签上注明的日期，在此规定时间内， 该原料药在规定条件下贮存时，仍符合规格标准，超过这一期限则不应当使用。
WHO TRS 1010 Annex 10 Stability testing of active pharmaceutical ingredients and finished pharmaceutical products
expiry date. The date given on the individual container (usually on the label) of a product up to and including which the active pharmaceutical ingredient and finished pharmaceutical product are expected to remain within specifications if stored under the long-term conditions at which stability was established. It is set for each batch by adding the shelf life to the date of manufacture.
有效日期。在确定稳定性的长期条件下储存时，在产品的单个容器（通常在标签上）上给出的日期，其中活性药物成分和成品预计将保持在标准范围内。每批产品通过将货架期+生产日期来确定。
utilization period (in-use period). A period of time during which a reconstituted preparation of the finished dosage form in a multidose container, or a moisture-sensitive product in a large-format final container (e.g. high-density polyethylene (HDPE) bottles of 500) can be used after opening.
使用期限：指一个时间段，在此期间多剂量包装制剂打开后可以重新配制，或水分敏感的大包装（例如高密度聚乙烯（HDPE））产品打开后可以使用。
shelf life. The period of time during which an active pharmaceutical ingredient (API) or finished pharmaceutical product (FPP), if stored under the conditions in which stability was established, is expected to comply with the specification as determined by stability studies on a number of batches of the API or FPP. The shelf life is used to establish the expiry date of each batch.
货架期：在一个时间段内，活性药物成分（API）或成品（FPP）在确定稳定性的条件下储存时，应符合通过对多个批次的 API 或 FPP 稳定性研究确定的标准。货架期用于确定每批产品的有效期。（注：按照这个定义，货架期指的是“N 年”，所以有效日期=生产日期+货架期）
retest date. The date after which an active pharmaceutical ingredient should be reexamined to ensure that the material is still in compliance with the specification and thus is still suitable for use in the manufacture of a finished pharmaceutical product.
复验日期：在该日期之后，应重新检查活性药物成分，以确保该材料仍然符合标准，仍适合用于制剂生产。
retest period. The period of time during which the active pharmaceutical ingredient (API) is expected to remain within its specification and, therefore, can be used in the manufacture of a given finished pharmaceutical product (FPP), provided that the API has been stored under the defined conditions. After this period, a batch of API destined for use in the manufacture of an FPP should be retested for compliance with the specification and then used immediately. A batch of API can be retested multiple times and a different portion of the batch used after each retest, as long as it continues to comply with the specification. For most substances known to be labile, it is more appropriate to establish a shelf life than a retest period. The same may be true for certain antibiotics.
复验期：预期活性药物成分（API）保持在其标准范围内的时间段，如果 API 已在规定条件下储存，则可用于制剂生产（FPP）。在此期间之后，应重新测试一批用于制造 FPP 的API 是否符合标准，然后立即使用。只要一批原料药继续符合规范要求，就可以对其进行多次复验，每次复验后所用批次的不同部分也可以复验。对于大多数已知不稳定的物质，确定货架期比复验期更合适。某些抗生素也可能是这样。
provisional shelf life. A provisional expiry date that is based on acceptable accelerated and available long-term data for the finished pharmaceutical product to be marketed in the proposed container-closure system.
暂定的货架期。根据待上市药品在计划使用的容器密封系统中进行的长期和加速数据得到的暂定有效日期。
release specification. The combination of physical, chemical, biological, and microbiological tests and acceptance criteria that determine the suitability of an active pharmaceutical ingredient or finished pharmaceutical product at the time of its release。
放行标准：物理测试、化学测试、生物测试和微生物测试以及在活性药物成分或成品放行时确定其适用性的可接受标准的组合。
shelf-life specification. The combination of physical, chemical, biological and microbiological tests and acceptance criteria that an active pharmaceutical ingredient or finished pharmaceutical product should meet throughout its retest period or shelf life.
货架期标准：活性药物成分或成品在其复验期或货架期内应满足的物理、化学、生物和微生物试验和可接受标准的组合。