存贮和运输：试验用药品新USP章节

GMP News
14/07/2016

Storage and Transport: New USP Chapter for Investigational Drug Products

存贮和运输：试验用药品新USP章节

In the Pharmacopeial Forum 42(4) [Jun-Jul 2016], the General Chapters - Packaging and Distribution Expert Committee of the U.S. Pharmacopeial Concention (USP) proposed a new chapter as an addition to the Good Storage and Distribution Practices for Drug Products chapters [1079]. This new subchapter should focus on investigational drug products (IDPs; investigational medicinal products in Europe, IMPs).

在USP药典论坛42（4）【2016年6-7月】中，通则---USP包装和运输专家委员会拟定了一份新的章节，作为对“药品优良存贮和销售规范【1079】章节”的补充。这个新的子章节着眼于试验用药品（IDP、欧洲试验用药，IMP）。

In the introduction, USP acknowledges that IDPs differ from commercial products:

在概述中，USP讲了IDP与商业化药品不同的地方：

• Small quantities for many different sites
• 对于许多不同工厂来说其数量很小
• Less stability data available especially for early phases of clinical trials
• 能获得的稳定性数据较少，尤其是临床试验的早期
• Temperature excursions of a single container "may jeopardize the entire clinical trial outcome"
• 单个包装的温度超范围“可能会危及整个临床试验的结果”
  

Another challenge are different distribution requirements for IDPs in various countries. Sponsors should be aware of this.

另一个挑战是在不同国家销售对IDP有不同要求。申报者要明白此点。

The key expectations specified in the proposed new chapter are:

在拟定的新章节中列出的关键要求有：

• Storage in a safe and secured area at labelled storage conditions
• 存贮在具备标签标示存贮条件的安全区域
• Segregation for IDPs not or not yet dispensed yet and for IDPs awaiting return to sponsor or contractor
• 将尚未拆分的IDP与等待退回给申报者或合同生产方的IDP分开
• Site qualification audits need to be performed
• 要进行现场确认审计
• Anticipation and tracking of expiry or re-test extensions (according to different local regulatory requirements)
• 参与和追踪复验期或有效期延长（根据不同的当地法规要求）
• Packaging qualifications should be the same as for commercially available drug products
• 包装确认应该与市场可以获得的药品相同
• Consideration of important distribution risk factors (e.g. distance, time, temperature, handoffs, packaging)
• 要考虑进口销售风险因素（例如，距离、时间、温度、转手、包装）
• Confirmation that proper steps are taken to ensure IDP supply chain integrity (including checklists for patients)
• 确认采取适当的措施来保证IDP供应链完整性（包括患者用的检查清单）
• Unblinded IDPs should be quarantined
• 已揭盲的IDP应隔离存放
• Comparators should be shipped and stored according their (new) IDP labelling
• 参比药应根据其（新）IDP标签运输和存贮
  

The draft chapter also gives a detailed example for calculating a rating of shipment risk that can help to identify probability and impact of missteps in the supply chain.

草案还给出了详细的计算运输风险等级的例子，可以帮助识别供应链中错误步骤的可能性及其影响。

The deadline for comments is September 30, 2016

征求意见截止日期为2016年9月30日。

After registration on the USP Pharmacopeial Forum website the complete drafts can be accessed.

在药典论坛注册后即可获取完整草案。

来源：http://zhuyujiao1972.blog.163.com/blog/static/9869472720167711435969/

〈1079.1〉 Storage and Transportation of Investigational Drug Products        研究药品的储存和运输