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20170830 ECA新闻:FDA对单位剂量重新包装的固体口服剂型有效期计算指南草案

2017-10-23  留在家里

30.08.2017

FDA Draft Guidance on Expiration Dating ofUnit-Dose repackaged Solid Oral Dosage Forms

FDA对单位剂量重新包装的固体口服剂型有效期计算指南草案

The U.S. Food and Drug Administration(FDA) proposed to tighten the previously proposed expirationdates for oral solid drugs from one year to just six months after they arerepackaged into unit doses, except under certain circumstances. This is inline with USP (United States Pharmacopeia) standards on expiration dating.

美国FDA拟加严之前所拟的固体口服药品的有效期,从其再包装至单位剂量之后的一年缩短至6个月,某些特定情形除外。这与USP对有效期计算的标准是一致的。

The FDA states that this action was taken in responseto 'an increasing demand in various health care settings for solid oraldosage form drug products repackaged into unit-dose containers, which hold aquantity of drug for administration as a single dose. The increase in unit-doserepackaging has led to questions regarding stability studies and appropriateexpiration dates for these repackaged products'.

FDA声称采取此措施是响应“口服固体药品重新包装至单位剂量容器后不同卫生设置不断增长的需求,其中一个包装是单次服用的剂量数。单位剂量包装的增长已引出了关于稳定性试验,和这些重新包装后药品给定适当有效期的问题。”

The draft guideline Expiration Datingof Unit-Dose Repackaged Solid Oral Dosage Form Drug Products was announced on August 8, 2017, and replaces thedraft guidance for industry Expiration Datingof Unit-Dose Repackaged Drugs: Compliance Policy Guide (2005). In addition, once final, it will supersede Compliance PolicyGuide 480.200 Expiration Dating of Unit-Dose Repackaged Drugs (1995). Comments regarding the draft document should besubmitted within 60 days of publication.

201788FDA发布了指南草案“单位剂量重新包装的固体口服剂型有效期计算”,替代行业指南草案“单位剂量重新包装药品有效期计算:符合性政策指南(2005)”。此外,最终定稿之后,它会替代“符合性政策指南480.200单位剂量重新包装药品有效期计算(1995)”。关于此草案文件应在发布之后60天提交。

In the previous draft guidance on expiration datingissued in May 2005, the FDA had proposed to set the expiration date for nonsterile,unit-dose repackaged drugs to one year, which was also aligned with USPstandards at the time for beyond use dating for unit-dose repackaging bydispensers.

在之前20055月发布的有效期计算的指南草案中,FDA提议为非无菌单位剂量重新包装药品设定有效期为1年,这与USP中当时规定的分销商单位剂量重新包装后超出使用日期是一致的。

According to the FDA, the present draft guidance'addresses repackaging of prescription and over-the-counter solidoral dosage form drugs into unit-dose containers by commercialpharmaceutical repackaging firms that are required to register with FDAunder section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)and to comply with current good manufacturing practice (cGMP) regulations in 21CFR parts 210 and 211'.

根据FDA的观点,现在的指南草案“说明了处方药和OTC固体口服药品由商业药品重新包装公司重新包装至单位剂量容器的操作,这些公司应在FDAFDCA510部分注册,符合21CFR210211部分的CGMP要求。”

The 7-paged guidance does not cover

7页的指南不包括:

  • Other dosage forms (e.g., sterile, liquid, topical),

  • 其它剂型(例如,无菌、液体、局部)

  • Products repackaged by State-licensed pharmacies, Federal facilities,     and outsourcing facilities as defined under section 503B of the FD&C     Act.

  • 由国家批准的药房、联邦场所和FDCA503B部分定义的外包场所进行重新包装的药品

Background: 背景

FDA’s cGMP regulations for finished productsrequire that 'each drug product bear an expiration date determined byappropriate stability testing and that the date must be related to any storageconditions stated on the labeling, as determined by stability studies'.Samples used for stability testing must be in the same container-closure systemas the marketed drug to ensure the drug product’s safety and efficacy over itsintended shelf life.

FDA的制剂CGMP法规要求“每种药品均有经适当稳定性测试确定的有效期,日期必须与标签上声称的存贮条件相对应,该存贮条件是由稳定性试验确定的”。用于稳定性试验的样品必须与上市销售药品采用相同的包装容器系统,以确保药品在其既定的货架期内的安全性和有效性。

Additionally, United States Pharmacopeia (USP) GeneralChapter <7> Labeling states that “the label of an official drug product …shall bear an expiration date.” For unit-dose repackaged products, USP GeneralChapter <1178> Good Repackaging Practices recommends that the expirationdate “not exceed

另外,USP通则<7>标签中说“正式药品的标签……应有有效期”。对于单位剂量重新包装药品,USP通则<1178>优良分装规范建议有效期“不要超过

  • 6 months from the date of repackaging; or

  • 重新包装日起算6个月;或

  • the manufacturer’s expiration date; or

  • 生产商的有效日期;或

  • 25% of the time between the date of repackaging and the expiration     date shown on the manufacturer’s bulk article container of the drug being     repackaged,

  • 重新包装日与显示在生产商的等分装药品散装容器上标示有效期之间25%的时间

whichever is earlier.” 取其短者

FDA will not enforce certain stability studyrequirements for repackaged drug products in the following cases:

在以下情形中,FDA不会强制对重新包装后的药品实施特定的稳定性试验:

  • if an expiration date that does not exceed 6 months from the date of     repackaging is assigned, or

  • 如果有效期不超过重新包装后6个月;或

  • if 25 percent of the time between the date of repackaging and the     expiration date on the container of the original manufacturer’s product is     used as expiration date, whichever time period is shorter, and if the     following conditions are met:

  • 如果使用重新包装与原始生产商在在容器上给定的药品有效期之间25%时长作为有效期,取其短者,并且符合以下条件时:

  • The unit dose container complies with Class A or Class B standards as     described in USP General Chapter <671> Containers – Performance Testing, “Packaging System     Classification for Single-Unit Containers and Unit-Dose Containers for     Solid Oral Dosage Forms”;

  • 单位剂量容器符合USP通论<671>“容器----性能测试”、“固体口服制剂单位剂量容器和单次剂量容器包装系统分类”中A类或B类标准;

  • The unit-dose repacking container provides light protection equal to     or greater than that of the drug product’s original container closure     system if the drug product is sensitive to light;

  • 药品对光敏感,单位剂量重新包装容器的光保护性能等同或优于药品原始容器包装系统;

  • The drug product’s original container has not been opened before and     the entire contents are repackaged in one operation;

  • 药品的原始容器之前未打开,一个容器中所有药品在一次操作中全部重新包装完成;

  • Repackaging and storage occur in an environment that is consistent     with the conditions described in the original drug product’s labeling     (e.g. temperature and humidity, otherwise, if not specified in the     original labeling, refer to definitions for “controlled room temperature”     and “dry place” in USP <659> Packaging and Storage Requirements);     and

  • 重新包装和存贮的环境与原始药品的标示所述条件一致(例如,温度和湿度,如原始标签未指定,可参见USP<659>“包装和存贮要求”中“受控室温”和“干燥处”的定义);以及

  • The drug product’s labeling does not caution against repackaging.

  • 药品的标示没有重新包装注意事项。

The FDA also proposes to permit the expiration date toexceed the ones described above, provided the above-listed conditions aremet and if repackagers have supportive data from appropriate studies (includinga risk-based assessment), using an adequate number of samples. Thesesamples need to demonstrate that the container closure system used forrepackaging is at least as protective for the drug product as the originalpackaging. However, 'the expiration date of the repackaged product doesnot exceed the original manufacturer’s expiration date'

FDA还提议当符合上述条件,并且重新包装商有使用足够数量样品进行适当研究的支持数据(包括基于风险的评估)时,允许有效期超过上述日期。这些样品需要证明用于重新包装的容器密闭系统至少与原始包装对药品的包装性能相等同。但是,“重新包装药品的有效期不得超过原始生产商的有效期”。


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