SUPAC-IR 问答-6

beiwei5du

STABILITY/CHANGE IN BATCH SIZE

1.    Q: When the documentation for a change is one batch on long term stability, is there a time limit between implementation of the change and initiation of the stability study?

1. 问题：当变更的文件资料是关于长期稳定性研究的一个批号时，执行变更与开始稳定性研究之间是否有时间限制？

A: No. But the stability study should start as soon as possible after the drug product is prepared in the market container.

回答：没有时间限制。但稳定性研究应当在药品以上市的容器包装后尽快开始。

2.    Q: What is the stability requirement for a level 3 change involving a product with multiple strengths packaged in bottles and blisters? SUPAC-IR states one batch. Can we bracket?

2.问题：涉及瓶装和水泡眼包装的多个规格的产品，其3 级变更的稳定性要求是什么? SUPAC-IR指出一个批号。我们是否能用括号法?

A: Testing and data collection involving the use of product bracketing are not the subject of SUPAC-IR. Bracketing may be used with prior approval of the Agency. The amount of data required depends on the type of change and whether or not there is a significant body of data available. If an applicant plans to bracket, the proposed protocol should be submitted to the Agency. This plan should include a protocol for each product. It should indicate all of the approved packaging configurations, and what strengths are approved for each of these. It also should include the approved stability test protocol.

回答：使用产品括号法的试验和数据收集不属于SUPAC-IR讨论的内容。括号法可在向FDA 申报前使用。需要的数据量取决于变更的类型，以及是否有相当数量的数据。如果申请人计划采用括号法，提出的方案应当上报给FDA。这一计划应当包括每种产品的对应方案。计划应当指出所有批准的包装外形，以及每种包装外形批准了哪些规格的产品。计划还应当包括批准的稳定性试验方案。

3.    Q: Who determines how many batches are required for stability when the documentation requests 1-3?

3.问题：文件资料要求1-3 批，由谁决定稳定性研究需要多少批?

A: The answer will be dependent on the specific drug product and the amount of data already available. The appropriate review division should be contacted for further guidance.

回答：答案取决于具体的药物及已有的数据量。要了解其他适用的指导原则，请与相应的审评部门联系。

4.    Q: When accelerated stability data are required, is that comparative data?

4. 问题：当需要加速稳定性试验数据时，是否为对照数据?

A: Yes. Historical data may be used for comparison.

回答：是的。历史数据可用于比较。

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小金库

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