刚刚，EDQM-OMCL发布了《实验室样品管理指南》，内容涵盖样品的接收、处理、防护、标识、可追溯性、测试期间存储、留存样品存储与取用及处置等环节，如下：

 

 

 

 

具体内容如下：

 

General European OMCL Network (GEON)

欧洲官方药品检验实验室通用网络（GEON）

 

QUALITY MANAGEMENT DOCUMENT
质量管理文件

 

PA/PH/OMCL (16) 89 R3
PA/PH/OMCL（16）89 R3

 

MANAGEMENT OF SAMPLES
样品管理

 

 

 

Management of Samples
样品管理

 

Guideline for OMCLs
官方药品检验实验室（OMCL）指南

 

Note: Mandatory requirements in this document are defined using the terms "shall" or "must".The use of "should" indicates a recommendation, for these parts of the text other appropriately justified approaches are acceptable.The term "can" indicates a possibility or an example with non-binding character.

注：本文件中的强制性要求通过术语 “shall”（应）或 “must”（必须）来界定。“should”（宜）的使用表示一种建议，对于文本中的这些部分，其他经过合理论证的方法也可接受。术语 “can”（可）表示一种可能性或具有非约束性的示例。

 

Table of Contents
目录

 

Introduction.

引言

Objectives.

目标

Definitions.

定义

Responsibilities.

职责

Receipt.

接收

Handling and Protection.

处理与防护

Identification.

标识

Storage of Samples During Testing.

测试期间的样品存储

Storage of / Access to Retained Samples.

留存样品的存储 / 取用

Disposal.

处置

References.

参考文献

 

1. INTRODUCTION

引言

 

Sample management is critical to the accuracy and reliability of testing, and, therefore, for ensuring the validity of test results. This document describes archiving aspects for samples (initially mentioned in OMCL chapter of SP/WP/EC 02/05 DET) and provides requirements for management of samples. General archiving (ISO/IEC 17025:2017 deal with this topic 7.1 (Review of requests, tenders and contracts), 7.3 (Sampling), 7.4 (Handling of test or calibration items)).

样品管理对测试的准确性和可靠性至关重要，因此对确保测试结果的有效性也至关重要。本文件描述了样品的归档相关内容（最初在 SP/WP/EC 02/05 DET 的 OMCL 章节中提及），并规定了样品管理的要求。通用归档方面，ISO/IEC 17025:2017 涉及以下主题：7.1（请求、标书和合同的评审）、7.3（抽样）、7.4（测试或校准物品的处置）。

 

2. OBJECTIVE

目标

 

The purpose of this guideline is to describe how samples tested by OMCLs are managed, in what concerns: receipt, handling, protection, identification, traceability, storage, archiving and disposal of the samples.
本指南旨在描述官方药品控制实验室（OMCL）测试的样品如何管理，涉及以下方面：样品的接收、处理、防护、标识、可追溯性、存储、归档和处置。

 

3. DEFINITIONS

定义

 

Sample: Test items (ISO/IEC 17025: 2017), i.e. each item to be tested by the OMCL, as defined by the scope of the individual OMCL’s activities (e.g. APIs, medicinal products, medical devices, cosmetics, samples for PTS studies etc.).
Retained sample: samples that are archived for legal or other purposes.
样品：测试物品（ISO/IEC 17025:2017），即由各 OMCL 的业务范围所定义的、拟由 OMCL 测试的单个物品（例如，原料药、药品、医疗器械、化妆品、能力验证计划（PTS）研究用样品等）。留存样品：为法律或其他目的归档保存的样品。

 

4. RESPONSIBILITIES

职责

 

The OMCL should define the person(s) responsible for receipt, transport, identification, handling, testing, access (restricted), storage, retention and disposal of the samples. Written procedures shall be in place describing how the aforementioned activities are managed.
OMCL 应明确负责样品接收、运输、标识、处理、测试、取用（受限）、存储、留存和处置的人员。应制定书面程序，描述上述活动的管理方式。

 

5.RECEIPT
接收

 

The condition of the sample shall be inspected on arrival as per the agreement and following a clearly defined internal procedure, taking into account any legal or health and safety aspects which may apply.The outcome of the inspection (especially any deviation from standard conditions) shall be recorded.Where there is any reason for doubt as to the suitability of the received item, the responsible person, where appropriate, shall consult the sender and agree on appropriate action before proceeding. The outcome of this agreement shall be recorded.

样品到达时，应根据协议并遵循明确规定的内部程序检查其状况，同时考虑可能适用的任何法律、健康与安全方面的因素。检查结果（尤其与标准条件的任何偏差）应予以记录。如对接收到的物品是否适用存在任何疑问，相关负责人应酌情咨询发送方，并在继续操作前就适当的行动达成一致。该协商结果应予以记录。

 

During receipt, care should be taken to ensure that the samples are stored in a designated area for unregistered samples, under the prescribed storage conditions.The table below describes who may be contacted in case doubts arise or deviations are observed during receipt of a material:

接收期间，应注意确保样品在规定的存储条件下，存放于未登记样品的指定区域。下表说明在接收物料过程中若出现疑问或发现偏差时，可联系的人员：

 

Testing shall be carried out only after all deficiencies have been solved.
只有在所有缺陷都已解决后，方可进行测试。

 

6. HANDLING AND PROTECTION

处理与防护

 

All the measures necessary to handle the sample and protect their integrity (to avoid deterioration, loss or damage) shall be documented and followed by the personnel (e.g. special handling procedures as cool/frozen, protected from light, humidity, health and safety requirements, etc. required during storage, pre-testing, or testing). If appropriate, the samples should be accompanied by specific handling and storage instructions.Restricted access levels should be defined for the samples received and to be handled under specific protection measures (e.g. narcotics, cancerogenic samples).

处理样品并保护其完整性（避免变质、丢失或损坏）所需的所有措施都应形成文件，并由相关人员遵循（例如，储存、测试前或测试期间所需的冷藏 / 冷冻、避光、防潮、健康和安全要求等特殊处理程序）。如有必要，样品应随附具体的处理和储存说明。对于接收的以及需在特定防护措施下处理的样品（如麻醉药品、致癌样品），应界定受限的访问级别。

 

7. IDENTIFICATION

标识

 

The OMCL shall have a system to ensure that samples are uniquely identified (e.g. code, reference) and marked. The type of identification system depends on the organisation, e.g. it may be linked to the analytical study. The identification shall be retained while the item is under the responsibility of the laboratory.The identification system shall allow the sample to be traced back to a single source and transport conditions. A common identifier may only be given to several items if they are from the same batch and were sampled, transported and received together.

官方药品检验实验室（OMCL）应建立一套系统，以确保样品能被唯一识别（如编码、参考号）并加标记。识别系统的类型取决于机构，例如，它可能与分析研究相关联。在物品由实验室负责期间，识别标识应予以保留。该识别系统应能使样品追溯到单一来源和运输条件。只有当多个物品来自同一批次且同时采样、运输和接收时，方可赋予它们共同的识别符。

 

8. TRACEABILITY

可追溯性

 

The sample's unique identifier shall be recorded on all paper and/or electronic records generated by the OMCL from sample labels, it shall be possible to establish when a specific sample arrived at the OMCL and, from the receipt of the sample through to its testing and storage.
Likewise, it shall be possible to identify and locate the sample by the records available. Special care shall be taken if there is any possible confusion (physically or when samples are referred to in records or other documents).

药品检验实验室（OMCL）从样品标签生成的所有纸质和 / 或电子记录中，均应记录样品的唯一标识。应能够确定特定样品到达 OMCL 的时间，以及从样品接收、检验到储存的全过程信息。同样，应能够通过现有记录识别并定位样品。若存在任何可能的混淆情况（无论是实物层面，还是在记录或其他文件中提及样品时），均应特别留意。

 

9. STORAGE OF SAMPLES DURING TESTING

检验期间的样品储存

 

Once the samples have been received and accepted and it has been confirmed that the testing order submitted is complete, the samples shall be placed in the appropriate storage area, under the prescribed storage conditions.

样品接收并验收，且确认提交的检验指令完整后，应将样品放置在规定储存条件下的适当储存区域。

 

Samples that pose a safety risk and samples subject to special legal requirements (for instance, infectious substances, samples with high pharmaceutical activity, toxic substances and psychotropic drugs) should be stored in specially designated storage areas.

存在安全风险的样品，以及受特殊法律要求约束的样品（例如，传染性物质、高药理活性样品、有毒物质和精神药品），应储存在专门指定的储存区域。

During testing, the samples shall be stored and handled in accordance with the OMCL's procedure and the manufacturer's requirements. Any other legal or storage specific requirements should also be taken into consideration. If the manufacturer defines specific storage conditions for samples, the OMCL shall ensure that such conditions are maintained, monitored and recorded. All storage deviations from the prescribed conditions shall be recorded. In case of a significant deviation from specified conditions, a disclaimer in the report, indicating which results may be affected by the deviation, shall be included.

检验期间，样品的储存和处理应符合药品检验实验室（OMCL）的程序以及制造商的要求。还应考虑任何其他法律或特定储存要求。若制造商为样品规定了特定储存条件，OMCL 应确保维持、监测并记录这些条件。所有偏离规定储存条件的情况均应记录。若与规定条件存在重大偏差，报告中应纳入免责声明，指明哪些结果可能受该偏差影响。

 

10. STORAGE OF / ACCESS TO RETAINED SAMPLES

留样的储存 / 获取

 

After being tested, samples should be retained until the report and all administrative actions have been finalised, according to the OMCL's policy. For samples from the medical supply chain that were found to be out of specification and samples for illegal products (falsified medicines, illicitly supplied products), the sample retention period should include the period of time required for appeal procedures to the competent authority.
If applicable (or if requested), the OMCL should define retention times for samples (remained in their original primary packaging), in accordance with the requirements of an accreditation body or equivalent (e.g. an audit cycle), national regulations or equivalent and any agreements with the competent authority. The OMCL shall describe the location (depending on the prescribed storage conditions) and level of access to the retained samples. Particular attention should be paid to the storage light (a cabinet) to prevent damage, deterioration or loss (e.g., as a result of temperature, humidity, light).

检验后，样品应根据药品检验实验室（OMCL）的政策，保留至报告及所有行政程序完成。对于医疗供应链中发现的不合格样品，以及非法产品（假药、非法供应产品）的样品，留样期限应涵盖向主管部门申诉程序所需的时间。如适用（或应要求），OMCL 应根据认证机构或等效机构的要求（如审核周期）、国家法规或等效规定，以及与主管部门的任何协议，确定样品（保留原始内包装）的留存时间。OMCL 应说明留样的存放位置（取决于规定的储存条件）及获取权限。应特别注意储存光照（如储柜），以防止样品因温度、湿度、光照等因素受损、变质或丢失。

 

11. DISPOSAL

处置

 

The OMCL shall ensure that a proper disposal procedure in accordance with national legal requirements is in place and that any agreements with the competent authority are adhered to.

OMCL应确保建立符合国家法律要求的适当处置程序，并遵守与主管部门达成的任何协议。

 

12. REFERENCES

参考文献

 

ISO/IEC 17025:2017 - General requirements for the competence of testing and calibration laboratories

ISO/IEC 17025:2017 - 检测和校准实验室能力的通用要求

 

来源：Internet

关键词： 实验室 样品管理 指南