翻译：Julia 来自：蒲公英
07.06.2017
FDA Warning Letter shows the Importance of Sampling Plans and Strategies
FDA警告信显示出取样计划和策略的重要性
A recent FDA warning letter (February 14, 2017) cites a lack of scientifically sound and appropriate sampling plans for inspection.
最近的一封FDA警告信（2017年2月14日）引用了检查取样计划缺乏科学合理性和适当的取样计划。
The warning letter clearly states that the Company has no scientific justification for the number of reserve samples selected for the yearly visual examination aimed at identifying any evidence of drug product deterioration. Similarly, the Company lacks appropriate statistical sampling plans for the inspection of paper label rolls.
警告信清楚指出公司对于年度目视检查的留样数量没有进行科学论证，该目视检查目的是发现药品变质的证据。类似的，公司对于纸质标签卷的检查也缺乏适当的统计学取样计划。
Thus, this warning letter is a useful reminder of the regulatory need to sample a number of units (finished drug product, in-process materials, APIs, raw material, excipients, packaging components and labels) that is based on statistical criteria. Indeed, 21 CFR 211.84(b) requires that the number of containers to be sampled, and the amount of material to be taken from each container, shall be based upon appropriate criteria such as statistical criteria for component variability, confidence levels, and degree of precision desired, the past quality history of the supplier, and the quantity needed for analysis and reserve where required by 211.170.
因此，此警告信可以用来提醒大家，法规要求基于统计学标准来确定如何对大量的单位进行取样（制剂产品、中控物料、原料药、原料、辅料、包装部件和标签）。实际上，21 CFR 211.84(b)要求被取样容器的数量，以及从每个容器中取出的物料的数量均应基于适当的标准，如部件变动性统计学标准、置信水平和所需的准确度，以及供应商的过去质量历史，和分析所需数量和211.170所要求的留样数量。
Statistically-based sampling plans recognized by regulatory agencies are available (e.g. ISO 2859-1 or ANSI/ASQC Z1.4 for series of lots; e.g. ISO 2859-2 or ANSI/ASQC-Q3 for isolated lots) and presumably could be used for sampling the above mentioned reserve samples or rolls leaflets. In fact, one can classify the material to be sampled in three general categories:
法规机构认可的基于统计学的取样计划是可以获取的（例如用于批系列的ISO2859-1或ANSI/ASQC Z1.4，例如用于独立批次的ISO 2859-2 或ANSI/ASQC-Q3），并且也被接受可用于上述留样或卷轴式标签的取样。实际上，公司可以将需要取样的物料分为三大类：
1. Unitary material (it consists of essentially identical units e.g., finished product, leaflets, test tubes, vials, stoppers, medical devices etc.…)
视为一个整体的物料（其中含有基本相同单位，例如，制剂成品、标签页、试管、小瓶、塞子、药用器械等）
2. Particulate material (Powders of API, Excipient, granulate, blend etc.…)
颗粒性物料（原料药粉、辅料、颗粒、混合料等）
3. Bulky-continuous material (water, liquid solution, viscous solutions, gel, cream, compressed gas, steam etc.…)
散装连续物料（水、液体溶液、粘稠溶液、胶体、压缩气体、蒸汽等）
The first category of material is easily amenable to statistical sampling by attributes. Sampling of the other two categories is often based on a risk-based approach aimed at multi-point sampling and testing to capture any intra-batch variability. At either category, the ultimate aim the sampling plan is to test/inspect a scientifically-sound selected representative sample.
第一类物料很容易根据其属性取用统计学取样。其它2类的取样则通常是基于风险的方法，其目的是从多点取样并测试以捕捉批内的波动性。每一类中，取样计划的最终目的都是对科学合理选择的有代表性的样品进行检测。
Get more details in the FDA Warning Letter to Hospira Inc..
更多细节参见FDA发给HOSPIRA的警告信。
