SUPAC-IR 问答-7

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MISCELLANEOUS ISSUES

1.    Q: The recommended documentation for several SUPAC-IR changes indicates that "batch records" or "updated batch records" be submitted. Should copies of batch records be submitted with the appropriate filing? Is batch record defined as the actual blank floor work order or can another manufacturing process description be used? In which cases should the batch records be executed batch records?

1. 问题：多个SUPAC-IR变更建议的文件资料指出应当上报“批记录”或“更新的批记录”。批记录的副本应当与相应的资料一起上报吗？批记录是否指实际的自始至终的工作顺序，能否使用其他生产工艺描述？在什么情况下批记录必须为实际的批记录？

A: Wherever "batch record" occurs in the SUPAC-IR guidance, it means executed batch records. These records should be submitted in the designated filing.

回答：SUPAC-IR指导原则中，只要出现“批记录”，就指的是实际执行的批记录。这些记录应当在指定的申报资料中上报。

2.    Q: What does the Agency intend by "notification of change"? Should there be a separate communication to the Agency in addition to the annual report?

2.问题：FDA 的“变更通知”是什么用意？除了年度报告以外，与FDA 是否还有另外的交流机会?

A: The Agency should be notified of changes by the appropriate submission as described in the guidance..

回答：如该指导原则所述，通过申报资料，FDA应被告知有哪些变更。

3.    Q: May a firm make a SUPAC-IR change immediately after approval of the original application, or is there a waiting period?

3.问题：厂商在最初的申报批准后能否立即进行SUPAC-IR变更，或者是否要有等待期？

A: There is no waiting period. SUPAC-IR changes may be made as soon as the application is approved provided the appropriate data are available and filing criteria are addressed.

回答： 没有等待期。只要有相应的数据，符合申报标准，SUPAC-IR变更可以在申报批准后立即进行。

4.    Q: When there is a time lag between when changes are made under SUPAC and the submission of the annual report, what evidence is needed to show that an appropriate change will be submitted in the next annual report? What will the FDA investigator expect to see?

4.问题：当按照SUPAC 进行变更与递交年度报告之间有滞后时，需要什么证据显示在下一次年度报告中将上报相应的变更？FDA研究者希望看到什么？

A: The regulations at 21 CFR 314.70 (d) govern the filing of annual reports. Changes are made according to the applicant's change policy/procedures; these are part of the cGMP requirements. Because all changes should be approved by the appropriate quality unit, some set of documentation (e.g., development protocols, validation runs, batch records, etc.) should exist before the change is made. The investigator would expect to see this documentation.

回答： 21 CFR 314.70 (d)的条例规定了对年度报告上报的要求。变更按照申请人的变更政策/程序进行；这是cGMP要求的一部分。由于所有的变更都须由相应的质量管理单位批准，因此在进行变更前应当有一些配套文件（例如开发方案、验证程序、批记录等）。FDA研究者希望看到这些文件。

5.    Q: Should the information described under "documentation" be submitted in the filing, or does having the appropriate information on site for the inspection satisfy the requirement?

5.问题：“文件”中描述的信息应当按申报资料上报吗，或者说是否只要在地点保留相应的信息以备检查就能符合要求？

A: The documentation should be included in the designated filing regardless of whether a supplement (prior approval or changes being effected) or annual report is used.

回答：文件应当包括在指定的申报资料中，不论使用补充申请（prior approval or changes being effected），还是年度报告。

6.    Q: Are changes such as tablet shape and size covered under SUPAC-IR?

6. 问题：片剂形状和大小变更是否适用于SUPAC-IR？

A: In general, changes involving size and/or geometry of the tablet are not covered under SUPAC-IR, and would need prior approval supplements. However, changes in thickness due to a composition change may be covered under SUPAC-IR

回答：一般情况下，涉及片剂大小和/或几何形态的变更不适用于SUPAC-IR，但应按Prior approval suppleme nt申报。但因成分变化引起的厚度变更可能适用于SUPAC-IR。

7.    Q: What does the Center expect relative to validation for SUPAC-IR changes?

7.问题：相对于SUPAC-IR变更的验证，CDER有什么期望?

A: A summary of the validation data should be included in submissions describing process changes.

回答：描述工艺变更的申报材料中应当包括验证数据的总结。

8.    Q: What is meant by "validated range"?

8. 问题：“验证的范围”是指什么？

A: Validated ranges mean the upper and lower limits are validated for a particular manufacturing process. An example of this is the time required during mixing of bulk powders which supports the minimum and maximum time needed to optimize mixing of the contents

回答：验证的范围指验证的某个生产工艺的上限和下限。例如混合原料药粉末所需的时间，该时间可支持优化各种成分混合工艺所需的最短时间和最长时间。

9.    Q: Based on the SUPAC video, it appears that a certificate of analysis and dissolution data need not be submitted in annual reports, but should be held on site. Is this correct?

9.问题：根据SUPAC录像，似乎不需要在年度报告中上报分析验证和溶出数据，但需要保存在地点。是这样吗？

A: These data should be submitted in the annual report.

回答：这些数据应当在年度报告中上报。

10.  Q: A "significant body of data" is mentioned in several places in the SUPAC-IR guidance. What does this mean?

10. 问题：SUPAC-IR指导原则中几次提到“相当数量的信息”。如何理解？

A: If an applicant for a new molecular entity has at least five years of post-approval manufacturing experience, or if the applicant for a new dosage that is an immediate release solid oral, has at least three years of post-approval manufacturing experience, the Center believes that a "significant body of information" exists for that product.

回答：如果新分子实体的药物申请人有至少5 年的批准后生产经验，或如果口服固体制剂增加新剂量申请人有至少批准后3 年的生产经验，则CDER认为该产品有“相当数量的数据”。

11.  Q: In the SUPAC-IR guidance document, what is meant by a "short period of time"?

11.问题： SUPAC-IR 指导原则中，“短期”是指什么？

A: Because it is difficult to specify a single time frame which could be applied to all situations for drug products, the appropriate chemistry team leader should be consulted. Each situation will be defined on a case by case basis.

回答：由于很难为药品所有情况指定一个通用的时限标准，应当咨询相应的化学团队负责人。每种情况应当分别指定相应的时限。

12.  Q: If a new dosage form of a product that has been marketed for a number of years is accepted for filing as a generic product through the suitability petition process, will it be considered to have a "significant body of information"?

13.  12.问题：如果已经上市了几年的药品增加一种新剂型，允许通过suitability pe tition p r oces s 按仿制药申报，是否可以认为其具备“相当数量的信息”？

A: No, it would not. As noted in the definition for significant body of information, a significant body of information is likely to exist after three years of commercial experience for new dosage forms.

回答：否，不能这样认为。如相当数量的信息的定义中所提到的，该新剂型上市销售3 年之后才可能具备相当数量的信息。

Date created: February 19, 1997; last update: July 6, 2005

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