首先进行风险评估，参考OMCL的试剂效期管理文件： Recommendations on setting the expiry period for commercial and in-house-prepared reagents used in the laboratories of the OMCL Network  OMCL 网络实验室中使用的商业化试剂和内部配制试剂有效期建立的建议，厂家规定了有效期的按厂家规定来，未规定有效期的自收到日期起最多五年，开封后试剂有效期依据试剂的性质不同，有三年，两年，一年，六个月等不同要求，输出风险评估结果后进行变更，修改SOP按照最新要求执行。

1. How does FDA interpret the regulations (21 CFR part 211) regarding the establishment of expiry dating for chemicals, reagents, solutions, and solvents?

   Laboratory “reagents, and standard solutions,” as referenced in the CGMP regulations at 21 CFR 211.194, includes laboratory chemicals such as solvents (including mobile phases), dry chemicals (salts, primary standards, etc.), and solutions (buffers, acids/bases, quantitative analytical preparations, etc.), whether purchased or prepared in-house. Laboratory reagents and solutions are used in analytical tests of components, in-process materials, and finished products.

   If the purchased laboratory reagent or solution includes a manufacturer’s suggested use-by or expiry date, that date should be followed.  For purchased laboratory reagents and solutions without a "use by" or expiry date, FDA would expect that an assessment be conducted (a literature review may be acceptable) of that specific chemical's or chemical family's stability and that an appropriate use-by or expiry date be determined.

   For in-house prepared solutions, such as mobile phases or other nonquantitative solutions, FDA would expect that an assessment be conducted (again, literature review may be acceptable) to determine an appropriate expiry period. However, for in-house prepared solutions used for quantitative analysis, such as sample or standard solutions used in assay or impurity testing or titration solutions, FDA requires that formal stability studies be conducted to determine an appropriate expiry. As mentioned in the ICH guidance for industry Q2B Validation of Analytical Procedures: Methodology, the stability of analytical solutions is a typical method variation that should be evaluated during robustness testing during method validation. Method validation is a CGMP requirement at 21 CFR 211.160(b).

   The determined use-by or expiry dates should be documented within a procedure and followed. Procedures for any in-house prepared laboratory solution should include the determined stability timeframe and should instruct that these solutions be labeled with the appropriately determined use-by or expiry date upon preparation and discarded upon expiration.

   These principles would also apply to active pharmaceutical ingredient (API) manufacturing and testing sites. The use of “reagents and solutions” and use-by dates are found throughout the ICH guidance for industry Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.

   References:

   • CFR 211.160: General requirements
   • CFR 211.194: Laboratory records
   • FDA Guidance for Industry, 2001, ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, Section 11, Laboratory Controls
   • FDA Guidance for Industry, 1996, ICH Q2B Validation of Analytical Procedures: Methodology

   Date: 7/19/2011

未开瓶按厂家标识月份最后一天。

开瓶后，自己做开瓶有效期。

①如内部未有详细的SOP规定的话，未开封试剂就按照厂家标注有效期，默认当月最后一天作为截止日。

②开封的试剂前期做好稳定性考察，进行有效期验证，也可以参考试剂厂家的稳定性报告进行规定

未开瓶参照试剂厂家有效期到期月的最后一天；开瓶后试剂有效期根据试剂对检验结果的影响程度制定开瓶效期考察，例如考察外观、水分等指标。

试剂有效期按种类进行分类管理，未开瓶的一般按照厂家标识效期管理、开瓶的按照不同类型、不同浓度、不同用途等分类管理。

可以参考GMP指南《试剂、试验用溶液、试验用水与耗材的管理》章节内容。

同时可参考OMCL的试剂效期管理文件： Recommendations on setting the expiry period for commercial and in-house-prepared reagents used in the laboratories of the OMCL Network  OMCL 网络实验室中使用的商业化试剂和内部配制试剂有效期建立的建议

第一版GMP指南试剂试液管理内容见7 试剂及试液的管理

可以规定到月份最后一天

这个是什么试剂，如果是一般甲醇什么的，可以到上个月，但是你们为啥定一个有效期？试剂复验期就好，只能说你们很教条。

既然厂家给的到月份，你按照厂家的要求，不超月份不就好了！

①参考制剂有效期的原则，进行相应的有效期缩减；

②同时增加外观检查的要求，比如有些试剂的外观发生变化可能会影响试剂使用时，停止使用该试剂；

③同步增加有效期考察，研究一个合适的内部有效期。

参考制剂的有效期制定，，可根据COA计算，如果厂家按照生产日期已经减了一个月，可以直接规定到有效期月份的月底；如果供应商没有根据有效期减一个月，保险起见，可根据生产日期减一天或者减一个月。