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剛剛,EDQM-OMCL發布了《實驗室樣品管理指南》,內容涵蓋樣品的接收、處理、防護、標識、可追溯性、測試期間存儲、留存樣品存儲與取用及處置等環節,如下:
具體內容如下:
General European OMCL Network (GEON)
歐洲官方藥品檢驗實驗室通用網絡(GEON)
QUALITY MANAGEMENT DOCUMENT
質量管理文件
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語 “shall”(應)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,其他經過合理論證的方法也可接受。術語 “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
Definitions.
定義
Responsibilities.
職責
Receipt.
接收
Handling and Protection.
處理與防護
Identification.
標識
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確性和可靠性至關重要,因此對確保測試結果的有效性也至關重要。本文件描述了樣品的歸檔相關內容(最初在 SP/WP/EC 02/05 DET 的 OMCL 章節中提及),并規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、標書和合同的評審)、7.3(抽樣)、7.4(測試或校準物品的處置)。
2. OBJECTIVE
目標
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 的業務范圍所定義的、擬由 OMCL 測試的單個物品(例如,原料藥、藥品、醫療器械、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
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 應明確負責樣品接收、運輸、標識、處理、測試、取用(受限)、存儲、留存和處置的人員。應制定書面程序,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,應根據協議并遵循明確規定的內部程序檢查其狀況,同時考慮可能適用的任何法律、健康與安全方面的因素。檢查結果(尤其與標準條件的任何偏差)應予以記錄。如對接收到的物品是否適用存在任何疑問,相關負責人應酌情咨詢發送方,并在繼續操作前就適當的行動達成一致。該協商結果應予以記錄。
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,應注意確保樣品在規定的存儲條件下,存放于未登記樣品的指定區域。下表說明在接收物料過程中若出現疑問或發現偏差時,可聯系的人員:
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、丟失或損壞)所需的所有措施都應形成文件,并由相關人員遵循(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),應界定受限的訪問級別。
7. IDENTIFICATION
標識
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)應建立一套系統,以確保樣品能被唯一識別(如編碼、參考號)并加標記。識別系統的類型取決于機構,例如,它可能與分析研究相關聯。在物品由實驗室負責期間,識別標識應予以保留。該識別系統應能使樣品追溯到單一來源和運輸條件。只有當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)從樣品標簽生成的所有紙質和 / 或電子記錄中,均應記錄樣品的唯一標識。應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,應能夠通過現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,應將樣品放置在規定儲存條件下的適當儲存區域。
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、高藥理活性樣品、有毒物質和精神藥品),應儲存在專門指定的儲存區域。
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符合藥品檢驗實驗室(OMCL)的程序以及制造商的要求。還應考慮任何其他法律或特定儲存要求。若制造商為樣品規定了特定儲存條件,OMCL 應確保維持、監測并記錄這些條件。所有偏離規定儲存條件的情況均應記錄。若與規定條件存在重大偏差,報告中應納入免責聲明,指明哪些結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,樣品應根據藥品檢驗實驗室(OMCL)的政策,保留至報告及所有行政程序完成。對于醫療供應鏈中發現的不合格樣品,以及非法產品(假藥、非法供應產品)的樣品,留樣期限應涵蓋向主管部門申訴程序所需的時間。如適用(或應要求),OMCL 應根據認證機構或等效機構的要求(如審核周期)、國家法規或等效規定,以及與主管部門的任何協議,確定樣品(保留原始內包裝)的留存時間。OMCL 應說明留樣的存放位置(取決于規定的儲存條件)及獲取權限。應特別注意儲存光照(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應確保建立符合國家法律要求的適當處置程序,并遵守與主管部門達成的任何協議。
12. REFERENCES
參考文獻
ISO/IEC 17025:2017 - General requirements for the competence of testing and calibration laboratories
ISO/IEC 17025:2017 - 檢測和校準實驗室能力的通用要求
來源:Internet