stabilitystudyofICH.pptVIP

Stability Testing Definition-定义 Stability: The capacity of a product to remain within specifications to ensure its identity, strength, quality and purity throughout the retest or expiry date. Stability studies should include long term stability study, accelerated stability study, intermediate stability study (if appropriate) and photostability testing (if appropriate). The choice of test conditions should follow ICH guidelines Q1A, Q1B, Q1C and Q1E. 稳定性：指产品保持其物理、化学、生物学稳定性及其疗效和安全性的能力。药品稳定性试验包括长期稳定性试验、加速稳定性试验及中间试验（必要时），光照试验（必要时）。稳定性试验应遵从ICH 指南 Q1A，Q1B, Q1C及Q1E。 ICH Q1A(R2) -Principle General Principles Stability Study 光照试验 Photostability Testing 长期稳定性试验 Long term stability study 中间试验 Intermediate stability study 加速稳定性试验 Accelerated stability study ICH Q1A(R2) - Guideline Selection of Batches Data from formal stability studies should be provided on at least three primary batches of the drug substance. The overall quality of the batches of drug substance placed on formal stability studies should be representative of the quality of the material to be made on a production scale. 正式的稳定性研究数据应由至少三批原料药得出，这些批次应达到中放最低量；所采用的合成路线应与大生产一致，制备工艺和操作流程模拟最终生产过程。 Container Closure System Same as or simulates the packaging proposed for storage and distribution. 用于稳定性研究的原料药应包装于与药物储存及运输相同或相似包装内。 ICH Q1A(R2) - Guideline Specification (ICH Q6A and Q6B) Stability studies should include testing of those attributes of the drug substance that are susceptible to change during storage and are likely to influence quality, safety, and/or efficacy. The testing should cover, as appropriate, the physical, chemical, biological, and microbiological attributes. Validated stability-indicating analytical procedures should be applied. Whether and to what extent replication should be performed will depend on the results from validation studies. 稳定性研究应该包括对有可能造成改变药物包装的因素，以及可能影响药物质量、安全性或药效的因素的考察；检验内容应该涵盖物理、化学、生物及微生物方面；所采用的分析方法应该经过稳定性指示验证的。试验是否需要重复以及重复次数应该取决于验证性研究结果