出差在外，暫停更新一周PDA的文件，分享一個這兩天被刷屏的WHO優良色譜規範，原文可參見閱讀原文連結，藍色字體部分為個人點評，以下連結中的內容為延伸閱讀，均來自於平臺之前的推送，與今天的文章會有關聯。
延伸閱讀
A－L－C－O－A
備份與歸檔的區別就是剪切和複製？
數據歸檔的頻率是多少？備份與歸檔的關係如何理解？
校準不能取代確認
1. INTRODUCTION AND SCOPE 介紹與範圍
The use of chromatography methods (such as High Pressure Liquid Chromatography (HPLC) and Gas Chromatography (GC)) in quality control laboratory analysis has increased significantly in recent years.
近年來色譜方法（如高壓液相色譜（HPLC）和氣相色譜（GC））的使用在QC實驗室分析中已有顯著增加。
HPLC更常規的叫法或許是高效液相色譜，P也可以理解是Performance。
HPLC and GC methods are used in, for example, the identification of materials and products, for determination of assay and related substances in materials and products, as well as in validation such as process validation and cleaning validation.
HPLC和GC方法被用於，例如，物料和產品鑑別、物料和產品中含量和有關物質檢測，以及驗證如工藝驗證和清潔驗證。
HPLC和GC的幾個典型應用。
Due to the criticality of the results obtained through chromatography, manufacturers should ensure that the data acquired is accurate and reliable. Results should meet ALCOA+ principles (i.e. attributable, legible, contemporaneous, original and accurate).
由於通過色譜獲得的結果非常關鍵，生產商應確保所獲取的數據的準確性和可靠性。結果應符合ALCOA+原則（即可追溯、清晰、同步、原始和準確）。
ALCOA+的說法應該可以算是WHO的原創，之前的系列推送中解讀過，不再重複，這裡所謂的Manufacturer其實也是WHO的常規說法，表示藥品生產企業，當然，對於GxP監管下的各實體，也是可以參考的。
This guideline provides information on good practices to be considered in the analysis of samples when chromatographic systems are used. The principles should be applied in the analysis of, for example, raw materials, starting materials, intermediates, in-process materials and finished products.
本指南提供了在使用色譜系統進行樣品分析時需要考慮的優良規範。在分析如原料、起始物料、中間體、中控物料和成品中應使用這些原則。
對之前的應用範圍的延續，只是部分起始物料是否適用GMP，其實不可很絕對地去說。
The principles contained in this guideline are applicable to all types of chromatographic analysis used in, for example, assay determination, testing for related substances and impurities, process validation, cleaning validation, cleaning verification and stability testing.
本指南中人原則適用於如含量檢測、有關物質和雜質檢測、工藝驗證、清潔驗證、清潔確認和穩定性測試中所用的所有類型色譜分析。
和前面的章節有重複~
2. GLOSSARY 術語解釋
ALCOA
A commonly usedacronym for 「attributable, legible, contemporaneous, original and accurate」.
常用術語，代表「可追溯、清晰、同步、原始和準確」。
ALCOA+
A commonly used acronym for 「attributable, legible, contemporaneous, original and accurate」 which puts additional emphasis on the attributes of being complete, consistent, enduring and available – implicit basic ALCOA principles.
常用術語，代表「可追溯、清晰、同步、原始和準確」，以及在其上增加ALCOA基本原則的更多屬性，即完整、一致、持久和可及性。
Backup 備份
A backup means a copy of one or more electronic files created as an alternative in case the original data or system are lost or become unusable (for example, in the event of a system crash or corruption of a disk). It is important to note that backup differs from archival in that backup copies of electronic records are typically only temporarily stored for the purposes of disaster recovery and may be periodically overwritten. Such temporary backup copies should not be relied upon as an archival mechanism.
備份指創建一份或多份電子文件，在原始數據或系統丟失或不可使用時（如系統崩潰或磁碟損壞）作為替代用途。注意備份與歸檔是不一樣的，電子記錄備份一般只是臨時存貯用於災難恢復，可能會定期覆蓋。不應依賴此種臨時備份件作為歸檔用途。
WHO的這一段其實是非常清楚地說明了備份和歸檔的區別，相比之下，FDA的定義還稍顯混亂。
Calibration 校正
The set of operations that establish, under specified conditions, the relationship between values indicated by an instrument or system for measuring (especially weighing), recording and controlling, or the values represented by a material measure, and the corresponding known values of a reference standard. Limits for acceptance of the results of measuring should be established.
在指定條件下建立儀器或系統測量指示值（尤其是稱重值）、記錄和控制，或物料測量代表值，與對應的一個標準物質已知值之間的關係的一系列操作。應建立測量結果的可接受限度。
國內似乎更多的叫法是校準~
Chromatographic column 色譜柱
A tube commonlyfilled with a stationary phase over which a sample and mobile phase move, used in chromatographic analysis.
一支通常用固定相填充，樣品和流動相在其中移動，用於色譜分析的柱子。
Data 數據
All original records and true copies of original records, including source data and metadata and all subsequent transformations and reports of these data, which are generated or recorded at the time of the GMP activity and allow full and complete reconstruction and evaluation of the GMP activity. Data should be accurately recorded by permanent means at the time of the activity. Data may be contained in paper records (such as worksheets and logbooks), electronic records and audit trails, photographs, microfilm or microfiche, audio- or video-files, or any other media whereby information related to GMP activities is recorded.
所有原始記錄和原始記錄的真實副本，包括源數據和元數據以及這些數據的所有後續轉移及報告。這些數據是在GMP活動時生成或記錄，可全面完整重構及評估該GMP活動。數據應在活動發生時採用永久方法準確記錄。數據可保存在紙質記錄上（例如工作記錄和日誌）、電子記錄上和審計追蹤上、圖片上、微縮膠捲上、影音文件或任何其它記錄與GMP活動有關信息的媒介上。
Data的定義其實不同的指南中的叫法都或多或少有區別，WHO關於Data的定義涵蓋了True Copy以及基於此產生的報告，這個範圍幾乎是包括了所有的電子和紙質記錄形式。
Exponential skim 指數撇除
The creation of a curvature in the skim line in an attempt to approximate the underlying baseline of the parent peak.
在撇去線上創建一個曲率以使其接近母峰的下基線。
Exponential curve fitting 指數曲線設置
The drawing of acurve using an exponential equation through the start and end of the child peak. The curve passes under each child peak that follows the parent peak; the area under the skim curve is subtracted from the child peaks and added to the parent peak.
使用指數方程畫一條通過子峰起點和結點的曲線。該曲線通過母峰後的所有子峰，將撇去曲線下的面積從子峰面積中扣除，加和到母峰面積上。
Front peak skim 前伸峰撇去
The process of integrating child peaks on the front (upslope) of a peak subject to specified criteria.
根據指定標準對一個峰的前沿部分（上斜部分）上的子峰進行積分的過程
Integration 積分
The process of applying specified parameters for chromatographic peaks (determination of height, area and retention time).
採用指定參數對色譜峰進行處理（確定峰高、峰面積和保留時間）
Metadata 元數據
Metadata is data about data that provides the contextual information required to understand those data. These include structural and descriptive metadata. Such data describe the structure, data elements, interrelationships and other characteristics of data. They also permit data to be attributable to an individual. Metadata necessary to evaluate the meaning of data should be securely linked to the data and subject to adequate review. For example, in weighing, the number 8 is meaningless without metadata, such as, the unit, milligram, etc. Other examples of metadata include the time/date stamp of anactivity, the operator identification (ID) of the person who performed an activity, the instrument ID used, processing parameters, sequence files, audit trails and other data required to understand data and reconstruct activities.
元數據是提供理解數據所需環境信息的數據。其中包括結構性和描述性元數據。此類數據描述結構、數據元素、相互關係和數據的其它特性。他們亦可讓數據追溯至個人。評估數據含義所需的元數據應與數據安全連結，並進行充分審核。例如，在稱重過程中，如果沒有元數據，如單位mg等，數字8是無意義的。元數據的其它例子包括一個活動的時間/日期戳，執行活動的操作員身份（ID）、所用儀器ID、處理參數、序列文件、審計追蹤和理解數據和重構活動所需的其它數據。
元數據保留的要求有的時候比較難以去界定，需要保留哪些數據有時業務搞不清楚，IT自然也就無法去實施。
Peak valley ratio 峰谷比
The peak to valley ratio is a measure of quality indicating how well the peak is separated from other substance peaks.
峰谷比是顯示一個峰與其它物質峰分離程度的質量指標
Qualification 確認
Documented evidence that premises, systems or equipment are able to achieve the predetermined specifications properly installed, and/or work correctly, and lead to the expected results.
證明設施、系統或設備能夠達到預定標準、適當安裝，和/或正確運轉並獲得預期結果的文件化證據。
Rear peak skim 峰尾撇去
The process of integrating child peaks on the tail (downslope) of a peak subject to specified criteria.
根據指定標準對一個峰的拖尾部分（下斜部分）上的子峰進行積分的過程
Restoration 恢復
The process of retrieving electronic data that had previously been backed-up and presented in a readable format.
恢復之前已有備份的電子數據並以可讀格式展現的過程。
Restoration和Retrievie兩個詞如何準確翻譯成中文也蠻糾結的。
Source data 源數據
Original data obtained as the first-capture of information, whether recorded on paper or electronically.
在信息首次捕獲中獲取的紙質或電子原始數據。
Straight line skim 直線撇去
The process ofdrawing a straight line through the start and end of a child peak. The height of the start of the child peak is corrected for the parent peak slope. The area under the straight line is subtracted from the child peak and added to the parent peak.
畫一條通過子峰起點和終點的處理方法。子峰的起點高度根據母峰斜率進行調整。直線下面的面積從子峰面積中扣除，加到母峰面積上。
Tangential skim 切線撇去
The process of integrating a small peak located on the tailing edge of a larger peak. The baseline of the small peak becomes a tangent drawn from the valley of the larger peak to the tangent point on the chromatogram.
對一個較大峰的尾部邊緣上一個小峰進行積分的過程。小峰的基線成為大峰峰谷至色譜圖切點的一條切線。
Validation 驗證
Action of proving and documenting that any process, procedure or method actually and consistently leads to the expected results.
提供和記錄所有工藝、程序或方法實際一致獲得預期結果的行動。
確認與驗證，不要再傻傻分不清~
Valley height ratio 峰高比
Valley height ratio is the ratio of the height of the child peak above the baseline to the height of the valley above the baseline. This ratio must be smaller than the specified value for the child peak to be skimmed.
峰高比是高於基線的子峰峰高比高於基線的谷高比值。該比率必須小於要撇去的子峰的指定值。