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剛剛，EDQM-OMCL發(fā)布了《實驗室樣品管理指南》，內(nèi)容涵蓋樣品的接收、處理、防護、標(biāo)識、可追溯性、測試期間存儲、留存樣品存儲與取用及處置等環(huán)節(jié)，如下：

 

 

 

 

具體內(nèi)容如下：

 

General European OMCL Network (GEON)

歐洲官方藥品檢驗實驗室通用網(wǎng)絡(luò)（GEON）

 

QUALITY MANAGEMENT DOCUMENT
質(zhì)量管理文件

 

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

 

MANAGEMENT OF SAMPLES
樣品管理

 

 

 

Management of Samples
樣品管理

 

Guideline for OMCLs
官方藥品檢驗實驗室（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：本文件中的強制性要求通過術(shù)語 “shall”（應(yīng)）或 “must”（必須）來界定。“should”（宜）的使用表示一種建議，對于文本中的這些部分，其他經(jīng)過合理論證的方法也可接受。術(shù)語 “can”（可）表示一種可能性或具有非約束性的示例。

 

Table of Contents
目錄

 

Introduction.

引言

Objectives.

目標(biāo)

Definitions.

定義

Responsibilities.

職責(zé)

Receipt.

接收

Handling and Protection.

處理與防護

Identification.

標(biāo)識

Storage of Samples During Testing.

測試期間的樣品存儲

Storage of / Access to Retained Samples.

留存樣品的存儲 / 取用

Disposal.

處置

References.

參考文獻

 

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)).

樣品管理對測試的準(zhǔn)確性和可靠性至關(guān)重要，因此對確保測試結(jié)果的有效性也至關(guān)重要。本文件描述了樣品的歸檔相關(guān)內(nèi)容（最初在 SP/WP/EC 02/05 DET 的 OMCL 章節(jié)中提及），并規(guī)定了樣品管理的要求。通用歸檔方面，ISO/IEC 17025:2017 涉及以下主題：7.1（請求、標(biāo)書和合同的評審）、7.3（抽樣）、7.4（測試或校準(zhǔn)物品的處置）。

 

2. OBJECTIVE

目標(biāo)

 

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藥品控制實驗室（OMCL）測試的樣品如何管理，涉及以下方面：樣品的接收、處理、防護、標(biāo)識、可追溯性、存儲、歸檔和處置。

 

3. DEFINITIONS

定義

 

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.
樣品：測試物品（ISO/IEC 17025:2017），即由各 OMCL 的業(yè)務(wù)范圍所定義的、擬由 OMCL 測試的單個物品（例如，原料藥、藥品、醫(yī)療器械、化妝品、能力驗證計劃（PTS）研究用樣品等）。留存樣品：為法律或其他目的歸檔保存的樣品。

 

4. RESPONSIBILITIES

職責(zé)

 

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 應(yīng)明確負責(zé)樣品接收、運輸、標(biāo)識、處理、測試、取用（受限）、存儲、留存和處置的人員。應(yīng)制定書面程序，描述上述活動的管理方式。

 

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.

樣品到達時，應(yīng)根據(jù)協(xié)議并遵循明確規(guī)定的內(nèi)部程序檢查其狀況，同時考慮可能適用的任何法律、健康與安全方面的因素。檢查結(jié)果（尤其與標(biāo)準(zhǔn)條件的任何偏差）應(yīng)予以記錄。如對接收到的物品是否適用存在任何疑問，相關(guān)負責(zé)人應(yīng)酌情咨詢發(fā)送方，并在繼續(xù)操作前就適當(dāng)?shù)男袆舆_成一致。該協(xié)商結(jié)果應(yīng)予以記錄。

 

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:

接收期間，應(yīng)注意確保樣品在規(guī)定的存儲條件下，存放于未登記樣品的指定區(qū)域。下表說明在接收物料過程中若出現(xiàn)疑問或發(fā)現(xiàn)偏差時，可聯(lián)系的人員：

 

Testing shall be carried out only after all deficiencies have been solved.
只有在所有缺陷都已解決后，方可進行測試。

 

6. HANDLING AND PROTECTION

處理與防護

 

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).

處理樣品并保護其完整性（避免變質(zhì)、丟失或損壞）所需的所有措施都應(yīng)形成文件，并由相關(guān)人員遵循（例如，儲存、測試前或測試期間所需的冷藏 / 冷凍、避光、防潮、健康和安全要求等特殊處理程序）。如有必要，樣品應(yīng)隨附具體的處理和儲存說明。對于接收的以及需在特定防護措施下處理的樣品（如麻醉藥品、致癌樣品），應(yīng)界定受限的訪問級別。

 

7. IDENTIFICATION

標(biāo)識

 

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.

官方藥品檢驗實驗室（OMCL）應(yīng)建立一套系統(tǒng)，以確保樣品能被唯一識別（如編碼、參考號）并加標(biāo)記。識別系統(tǒng)的類型取決于機構(gòu)，例如，它可能與分析研究相關(guān)聯(lián)。在物品由實驗室負責(zé)期間，識別標(biāo)識應(yīng)予以保留。該識別系統(tǒng)應(yīng)能使樣品追溯到單一來源和運輸條件。只有當(dāng)多個物品來自同一批次且同時采樣、運輸和接收時，方可賦予它們共同的識別符。

 

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).

藥品檢驗實驗室（OMCL）從樣品標(biāo)簽生成的所有紙質(zhì)和 / 或電子記錄中，均應(yīng)記錄樣品的唯一標(biāo)識。應(yīng)能夠確定特定樣品到達 OMCL 的時間，以及從樣品接收、檢驗到儲存的全過程信息。同樣，應(yīng)能夠通過現(xiàn)有記錄識別并定位樣品。若存在任何可能的混淆情況（無論是實物層面，還是在記錄或其他文件中提及樣品時），均應(yīng)特別留意。

 

9. STORAGE OF SAMPLES DURING TESTING

檢驗期間的樣品儲存

 

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.

樣品接收并驗收，且確認提交的檢驗指令完整后，應(yīng)將樣品放置在規(guī)定儲存條件下的適當(dāng)儲存區(qū)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.

存在安全風(fēng)險的樣品，以及受特殊法律要求約束的樣品（例如，傳染性物質(zhì)、高藥理活性樣品、有毒物質(zhì)和精神藥品），應(yīng)儲存在專門指定的儲存區(qū)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.

檢驗期間，樣品的儲存和處理應(yīng)符合藥品檢驗實驗室（OMCL）的程序以及制造商的要求。還應(yīng)考慮任何其他法律或特定儲存要求。若制造商為樣品規(guī)定了特定儲存條件，OMCL 應(yīng)確保維持、監(jiān)測并記錄這些條件。所有偏離規(guī)定儲存條件的情況均應(yīng)記錄。若與規(guī)定條件存在重大偏差，報告中應(yīng)納入免責(zé)聲明，指明哪些結(jié)果可能受該偏差影響。

 

10. STORAGE OF / ACCESS TO RETAINED SAMPLES

留樣的儲存 / 獲取

 

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).

檢驗后，樣品應(yīng)根據(jù)藥品檢驗實驗室（OMCL）的政策，保留至報告及所有行政程序完成。對于醫(yī)療供應(yīng)鏈中發(fā)現(xiàn)的不合格樣品，以及非法產(chǎn)品（假藥、非法供應(yīng)產(chǎn)品）的樣品，留樣期限應(yīng)涵蓋向主管部門申訴程序所需的時間。如適用（或應(yīng)要求），OMCL 應(yīng)根據(jù)認證機構(gòu)或等效機構(gòu)的要求（如審核周期）、國家法規(guī)或等效規(guī)定，以及與主管部門的任何協(xié)議，確定樣品（保留原始內(nèi)包裝）的留存時間。OMCL 應(yīng)說明留樣的存放位置（取決于規(guī)定的儲存條件）及獲取權(quán)限。應(yīng)特別注意儲存光照（如儲柜），以防止樣品因溫度、濕度、光照等因素受損、變質(zhì)或丟失。

 

11. DISPOSAL

處置

 

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應(yīng)確保建立符合國家法律要求的適當(dāng)處置程序，并遵守與主管部門達成的任何協(xié)議。

 

12. REFERENCES

參考文獻

 

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

ISO/IEC 17025:2017 - 檢測和校準(zhǔn)實驗室能力的通用要求