药品的抢救

beiwei5du

下面是US FDA part 211 GMP法规的一条，供大家参考讨论。
§211.208   Drug product salvaging.

Drug products that have been subjected to improper storage conditions including extremes in temperature, humidity, smoke, fumes, pressure, age, or radiation due to natural disasters, fires, accidents, or equipment failures shall not be salvaged and returned to the marketplace.如果制剂产品如果遭受极端的储存环境，应不能挽救并重新回归市场（比如外箱被烧毁了，部分内盒或者安瓿还是好的，不管药品是否合格，都只有销毁）

Whenever there is a question whether drug products have been subjected to such conditions, salvaging operations may be conducted only if there is（当对制剂药品是否遭受此种极端天气有疑问时，只能在以下情况下予以挽救）

(a) evidence from laboratory tests and assays (including animal feeding studies where applicable) that the drug products meet all applicable standards of identity, strength, quality, and purity and 通过实验室检测和分析（如果适合，包括动物饲喂研究）证明药品满足所有的关于identity, strength, quality, and purity 标准。

(b) evidence from inspection of the premises that the drug products and their associated packaging were not subjected to improper storage conditions as a result of the disaster or accident. 通过对于药品储存现场检查证明药品和其包装没有遭受到不合适的储存环境。（比如火灾确实发生了，某一仓库离得比较远）

Organoleptic examinations shall be acceptable only as supplemental evidence that the drug products meet appropriate standards of identity, strength, quality, and purity. Records including name, lot number, and disposition shall be maintained for drug products subject to this section.（感官检查只有在药品满足相关标准的前提下作为补充证据）

1. What should a firm do if its drug products or components have been subjected to improper storage conditions such as those caused by a natural disaster?
Drug products that have been subjected to improper storage conditions (including extremes in temperature, humidity, smoke, fumes, pressure, age, or radiation) due, for example, to natural disasters, fires, accidents, or equipment failures shall not be salvaged and returned to the marketplace.  Such exposure can pose a serious risk to a drug’s identity, strength, quality, purity or safety (see 21 CFR Part 211.208, Drug Product Salvaging).  This fundamental CGMP principle applies to any component, in-process material, or finished drug product subjected to such conditions. （火灾中，制剂厂原辅料的情况外桶损坏，但内袋完好，按照该 条也应该是制剂厂销毁呢还是推到原料厂让原料厂评估是否返工之类的呢？？，感觉有点矛盾）
In some cases, there may be substantial and reasonable uncertainty whether a drug was subjected to these conditions. (不知情应该需要充分的理由） In such a circumstance, it is essential that a firm nonetheless err on the side of caution in its risk assessment to assure an appropriate lot disposition decision and conduct a rigorous evaluation in accord with the standards described under 21 CFR Part 211.208.  
When there is reasonable uncertainty whether a drug was subjected to such conditions, salvaging operations may be conducted only if there is evidence from laboratory testing that the drugs meet all applicable standards of identity, strength, quality, and purity, and from inspection that the drugs and their associated packaging were not subject to improper storage conditions as a result of the disaster or accident.
When determining whether drugs have been subjected to such improper conditions, a firm’s actions should include but not be limited to:（当确定药品是否遭受极端的环境时，公司应该执行以下措施，但不限于此）

• Obtaining supply chain information, including knowing the names and addresses of all suppliers and distributors of a drug (including components and packaging) to determine if there is a reasonable possibility that such materials were stored under improper conditions.
  

获取供应链信息，包括了解该药品涉及的所有供应商、分销商的名字和地址以合理的确定是否存在遭受极端环境的可能性。

• Determining details such as the timeframe, duration, nature, scope, and location of exposure as well as identity of all lots potentially subjected to the improper conditions (e.g., ramifications of a natural disaster such as power disruptions should be considered to assure a complete risk assessment).
  

弄清可能遭受极端环境的所有批次药品的暴露时间，暴露性质（比如冷热，辐射等等）、规模和地点以及身份等细节

• Obtaining certification (either on the certificate of analysis or as a separate statement) declaring that drug lots, including components and packaging, were not subjected to improper storage conditions.
  

获取表明药品批次未遭受极端环境的证明（分析检查报告或者单独的声明）

For more information, see references below.

Date: 4/22/2011

jacob3263313

这种情况少数，大部分都是销售公司退货或者物流公司退货，当然有被雨淋或者撞击等情况的破损

zysx01234

老外考虑的比较周到，不错。

syhorchid

谢谢分享