冷冻药品：要考虑的问题

GMP News
08/08/2016

Refrigerated Medicinal Products: Things to consider

冷冻药品：要考虑的问题

Based on the experience made in GDP inspections, the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has published things to consider for the transportation, packing, temperature management, the use of third party couriers and returns of refrigerated medicinal products:

根据GDP检查中获得的经验，MHRA公布了冷冻药品运输、包装、温度管理中所需考虑的事情，使用第三方货运和退货问题。

Packing of consignments and temperature management during transportation:

运输期间货物包装和温度管理：

• Refrigerated products should be packed in such a way as to ensure that the required temperatures are maintained throughout the journey
• 冷冻药品的包装应保证所需的温度在整个运输过程中能保持
• For small volumes of lower risk products, with short journey times of less than three hours, validated insulated containers can be used
• 对于小量低风险药品，低于3小时的较短运输时间，可以使用经过验证的隔热容器
• For extended journeys, gel or ice packs are added to the packaging to maintain appropriate temperatures throughout
• 对于较长的路程，凝胶或冰袋放到包装里维持整个运输过程适当的温度
• Larger volumes of refrigerated products will generally be shipped in refrigerated transport. This is particularly important if transportation times may be protracted or liable to delay
• 较大量的冷冻药品一般在冷冻条件下运输。如果运输时间可能会延长或延误时尤其重要。
  

The decisions made on how to proceed should be based on risk evaluation according to ICH Q9. However the temperature should be controlled and monitored anytime with calibrated devices. All transportation arrangements "should be regarded as an extension of the storage activities and distributors are expected to treat each journey as unique with the length and complexity, as well as any seasonal variations, being considered when choosing the packing method and mode of distribution."

要根据ICH Q9做出的风险评估来决定如何进行运输。但是，温度应该使用经过校正的装置全程受控和受到监测。所有运输安排“均应作为存贮活动的延伸，销售商在选择包装方法和销售模式时，要将每段运输路作为唯一情况来考虑，要考虑其长度、复杂性以及季节波动”。

And what about the Mean Kinetic Temperature (MKT)? Here, MHRA clearly describes the agency's thinking:

平均动力学温度又怎样呢？这里，MHRA清楚描述了当局的观点：

"The application of Mean Kinetic Temperature (MKT) to temperature monitoring of wholesale products is only appropriate where an acceptable MKT value is provided by the MA holder for a specific product, and the recording of temperature can be confirmed to be consistent and complete from the moment of leaving the manufacturer's premises. In practice the application of MKT fails where a complete chain of temperature recording cannot be allocated to a specific consignment of a product. Attempts to apply MKT have been proposed by wholesalers as an alternative to having adequate temperature control within their warehouses as well as attempting to downgrade the impact of temperature excursions. The use of MKT in the wholesale environment without robust supporting information and methodology is therefore discouraged".

“平均动力学温度应用到批发药品的温度监测只有当可接受的MKT值由MA持有人为我的天空的药品提供时才是恰当的，从离开生产商设施的那刻开始的温度记录可以被确认是一致的和完整的。在实际操作中，如果完整的温度记录链不能配置到指定的药品运输中，MKT的应用就是失败的。批发商曾经努力提议应用MKT，将其作为其仓库有足够的温控的替代方法，并努力将温度超出范围的影响减少。因此在没有严谨的支持性资料和方法时，不鼓励在批发环境中使用MKT。”

Third party couriers 第三方物流

• All couriers need to be qualified
• 所有物流公司都需要进行确认
• Chapter 7 of the EU GDP Guidelines (Outsourced Activities) should be considered
• 要考虑EU GDP指南的第7章（外包活动）的要求
  

Returns of refrigerated medicinal products 冷冻药品退货

• Because of challenges with refrigerated products, a subsequent resale should not be considered in any event
• 由于冷冻药品所面临的挑战，在任何情况下均不应考虑退货的重新销售
• Products can only be returned to saleable stock, if:
• 药品只有在以下情况下才可以退回到可销售库存
  - Supporting transport documentation and return forms should be available
  应该有支持性运输文件和退货表格
  - A trained person should examine the returned product
  经过培训人的检查所退回的药品
  - All checks need to be satisfactory and are documented
  要进行所有检查并记录
• If not returned to saleable stock, returns should be stored in a dedicated and marked area awaiting collection by a licensed disposal company.
• 如果没有退回可销售库存，退货应被存贮在专用的，经过标记的区域，等待有资质的处理公司来收集
  

For other returns, paragraph 6.3 of the EU-GDP Guidelines should be considered.

其它退货，应考虑EU GDP指南的第6.3段。

You will find more in the MHRA Inspectorate Blog "Refrigerated medicinal products, part 2: Transportation, packing, temperature management, the use of third party couriers and returns – some things to consider"

更多信息参见MHRA博文

来源:http://zhuyujiao1972.blog.163.com/blog/static/9869472720167911624955/