首页 > 资讯 > OGD再次澄清稳定性指南重要内容

出自识林

2014-05-31 Lachman CONSULTANTS

我已经收到许多电话和问询我在5月15日发布的稳定性指南的澄清中关于初始稳定性批次包装的问题。显然，仿制药办公室（OGD）也在这一问题上收到了问询邮件。因此需要进一步解释清楚，现在开始吧！

众所周知，OGD过去常常要求固体口服制剂有一批至少100,000个剂量单元的包装，大多数企业做得比要求略多一些。自从Hatch-Waxman法案通过后，这一直是OGD的准则。现在的指南要求是100,000个剂量单元包装的产品可以来自3批初始稳定性批次。今天据与OGD额外的直接联系后了解到，5月15日的文章中关于包装问题的概述是正确的，但是除此之外，为符合指南建议，需完全包装三批申报批中规模最小的一批。

因此，总共应包装100,000个剂量单位，但建议应对3批初始稳定性批次中规模最小的一批进行完全包装以满足稳定性指南的要求。当准备稳定性研究和包装3批初始稳定性批次时请考虑这一点。

Lachman CONSULTANTS - Bob Pollock先生 2014-05-29
编译：识林-椒 2014-05-31

Clarification of the Stability Clarification Front and Center!
Written by Bob Pollock • May 29, 2014

I have been getting lots of calls and questions on my blog post of May 15, 2014 on clarification of the stability guidance particularly on the issue of primary stability batch packaging (here). Apparently, the Office of Generic Drugs (OGD) has also received e-mails on this issue as well. So to clarify the clarification, here goes!

We all know that OGD used to require the packaging of at least 100,000 dosage units of solid oral dosage forms from a batch of at least 100,000dosage units and most firms made slightly more than that. This has been OGD’s mantra ever since Hatch-Waxman passed in 1984. The guidance now is that the 100,000 total packaged products can come from the three primary stability batches. Today, it was learned after additional direct contact with OGD that the packaging issue outlined in my post of May 15, 2014 is correct but, in addition, packaging the smallest of the three exhibit batches fully will meet the guidance recommendation.

Thus, a total of 100,000 dosage units in total should be packaged, but it is recommended that the smallest of the three primary stability batches be fully packaged to meet the stability guidance requirements. Take that into consideration when preparing for stability testing and packaging of the three primary stability batches.

For more information on stability or other regulatory issues please contact Joan Janulis at j.janulis@lachmanconsultants.com or one of our other regulatory experts at 516-222-6222.

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