PIC/S更新备忘录：与包装相关的GMP检查

1月19日，国际药品检查组织(PIC/S)更新了四篇检查相关的备忘录：

• 公用系统检查备忘录PI 009-4 Aide Memoire on Utilities

• 生物技术检查备忘录PI 024-3 Aide Memoires on Biotech

• 包装检查备忘录PI 028-2 Aide Memoire on Packaging

• 评估QRM实施备忘录PI 038-2 Aide Memoire on Assessment of QRM Implementation

以下是包装检查备忘录的内容，供参考：

1. 文档历史

Adoption by Committee  31 October 2008

Entry into force 1 March 2009

委员会通过: 2008年10月31日

生效: 2009年3月1日

2. 介绍

2.1. The process of packaging of medicinal products is listed among the risk factors that may affect the quality of the finished medicinal products and may also cause mix-ups.

对于可能会影响成品制剂质量并可能造成混淆的风险因素，需要将药品包装工艺列在其中。

2.2. The increased number of the defects of medicinal products occurred due to deficiencies in the process of labelling and packaging has drawn inspectors’ attention towards the need for identifying and clarifying the critical aspects of this specific stage of inspection, in order to have a uniform interpretation of the provisions of the current GMP guide concerning packaging of medicinal products and prevention of mix-up.

由于贴标和包装工艺中的缺陷而导致的药品缺陷数量增加，这引起了检查员的关注，即需要识别和澄清这一特定检查阶段的关键方面，以便对当前GMP指南中有关药品包装和防止混淆的规定有一个统一的解释。

2.3. In the light of technological progress, considering the wide variety of medicinal products developed, the 2005 PIC/S Seminar (Bucharest, Romania) was dedicated to the GMP inspection of the final stage of manufacturing process (primary and secondary packaging, labelling).

鉴于技术进步，考虑到所开发的多种药品，2005 PIC/S研讨会（罗马尼亚布加勒斯特）讨论GMP检查，专门致力于生产工艺的最后阶段（内包装和次级包装、贴标）。

The first version of the Aide-Memoire is the outcome from the 2005 PIC/S Seminar with the latest version providing updated cross-reference to the PIC/S GMP Guide PE 009-14.

备忘录的第一版是2005年PIC/S研讨会的成果，最新版本提供了对PIC/S GMP指南PE 009-14的更新交叉引用。

3.目的

3.1. The purpose of this document is to provide guidance for GMP inspectors in preparation for inspections. This document aims to define the minimal requirements acceptable for an inspector as well as the requirements that provide maximum safety for the finished product (“best practices”).

本文档的目的是为GMP检查员准备检查提供指南。本文档旨在界定检查员可接受的最低要求，以及为最终产品提供最大安全性的要求（“最佳实践”）。

3.2. The Aide-Memoire should enable the inspector to assess the GMP compliance of the packaging process using the quality risk management tools.

备忘录使得检查员能够使用质量风险管理工具，评估包装工艺的GMP符合性。

4. 范围

4.1 The following Aide-Memoire describes different areas which could be evaluated during the GMP inspection of packaging and labelling process. However, the Aide- Memoire should be considered as a non-exhaustive list of areas to be looked at during an inspection.

针对包装和贴标工艺的GMP检查，以下备忘录介绍了其中可以评估的不同区域。但是，备忘录应视为检查期间要检查的区域的非详尽列表。

4.2 At the time of issue, this document reflected the current state of the art. It is not intended to be a barrier to technical innovation or the pursuit of excellence. The advice in this Aide-Memoire is not mandatory for industry. However, industry should consider PIC/S recommendations and Aide-Memoires as appropriate.

在发布时，该文档反映了当前的最新状态。它无意成为技术创新或追求卓越的障碍。本备忘录中的建议并非行业必需的。但是，行业应酌情考虑PIC/S建议和备忘录。

5.  备忘录

1.1 Quality and purchasing 质量与采购

Notes:

• purchasing from approved suppliers;

• auditing the manufacturing sites of suppliers of primary packaging materials for sterile products (vials, rubber stoppers, syringes, etc.) and of printed materials;

• compliance with specifications;

• up-dating the documents (quality specifications), in accordance with the marketing authorization and any subsequent variations;

• delivery from supplier made such as to preserve the quality (to prevent contamination).

关注点：

•从批准的供应商处采购；

•对无菌产品（小瓶、橡胶塞、注射器等）内包装材料和印刷材料供应商的生产场所，进行审计；

•符合质量标准；

•根据上市许可和任何后续变更更新文件（质量标准）；

•供应商交货方式可以确保质量（防止污染）。

Crucial questions:

• What is the policy for suppliers’ approval?

• Show me the audit report

• Do the primary materials specifications comply with the Pharmacopoeial parameters and limits?

关键问题：

•批准供应商的政策是什么？

•给我展示：审计报告

•内包材质量标准是否符合药典参数和限度？

1.2 Receipt 接收

Notes:

• quality documents: certificates of analysis;

• checking the conditions for packages shipment and handling;

• integrity checks and identification of each batch of primary packaging material or printed material received;

• de-dusting and cleaning of packages on the outside (separate area).

关注点：

•质量文件：分析证书；

•检查运输和处理条件；

•对收到的每批内包材或印刷材料，进行完整性检查和鉴别；

•在外部（分开的区域）对包装进行除尘和清洁。

Crucial questions:

• Show me the records and SOPs which apply when receiving primary packaging materials or printed materials

• Describe internal labelling system

关键问题：

•给我展示：接收内包材或印刷材料时适用的记录和SOP

•描述内部贴标系统

（更多检查问题——未完待续）

Ref.: PI 028-2 Aide Memoire on Packaging. PIC/S. 19 January 2021

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