Expectations要求
Updated versions should be distributed in a timely manner.應(yīng)及時分發(fā)更新版本。
Obsolete master documents and files should be archived and their access restricted.
過時的主文件和檔案應(yīng)予以存檔，并限制對其的訪問。
Any issued and unused physical documents should be retrieved and reconciled.
所有已發(fā)放但尚未使用的實(shí)體文件，應(yīng)予以收回并進(jìn)行核對。
Where authorised by Quality, recovered copies of documents may be destroyed. However, master copies of authorised documents should be preserved.
經(jīng)質(zhì)量部門批準(zhǔn)，可銷毀收回的文件副本。但是，批準(zhǔn)過的主文件應(yīng)予以保留。
Potential risk of not meeting expectations/items to be checked
未滿足要求的潛在風(fēng)險/待檢查項(xiàng)目
There may be a risk that obsolete versions can be used by mistake if available for use.
如果過時版本仍可供使用，則可能存在被誤用的風(fēng)險。
Expectation要求
Document issuance should be controlled by written procedures that include the following controls:
文件發(fā)放應(yīng)通過書面程序進(jìn)行控制，該程序應(yīng)包括以下控制措施：
- details of who issued the copies and when they were issued;
記錄副本發(fā)放人及發(fā)放時間的詳細(xì)信息；
- clear means of differentiating approved copies of documents, e.g. by use of a secure stamp, or paper colour code not available in the working areas or another appropriate system;
采用清晰、可識別的方式區(qū)分已批準(zhǔn)的文件副本，例如使用工作區(qū)域沒有的安全印章或彩色紙張，或其它經(jīng)驗(yàn)證有效的控制方式；
- ensuring that only the current approved version is available for use;
確保只有現(xiàn)行批準(zhǔn)版本可供使用；
- allocating a unique identifier to each blank document issued and recording the issue of each document in a register;
為發(fā)放的每份空白文件分配唯一標(biāo)識符，并在登記冊中記錄每份文件的發(fā)放情況；
- numbering every distributed copy (e.g.: copy 2 of 2) and sequential numbering of issued pages in bound books;
為分發(fā)的每一份副本編號（例如：共2份，第2份），并對裝訂成冊的發(fā)放頁進(jìn)行連續(xù)編號；
- where the re-issue of additional copies of the blank template is necessary, a controlled process regarding re-issue should be followed with all distributed copies maintained and a justification and approval for the need of an extra copy recorded, e.g.: “the original template record was damaged”;
若有必要重新發(fā)放空白模板的額外副本，應(yīng)遵循關(guān)于重新發(fā)放的受控流程，保留所有已分發(fā)的副本，并記錄需要額外副本的理由和批準(zhǔn)情況，例如：“原始模板記錄已損壞”；
- critical GMP/GDP blank forms (e.g.: worksheets, laboratory notebooks, batch records, control records) should be reconciled following use to ensure the accuracy and completeness of records; and
關(guān)鍵GMP/GDP空白表單（例如：工作單、實(shí)驗(yàn)記錄本、批記錄、控制記錄）應(yīng)在使用后核對，以確保記錄的準(zhǔn)確性和完整性；以及
- where copies of documents other than records, (e.g. procedures), are printed for reference only, reconciliation may not be required, providing the documents are time-stamped on generation, and their short-term validity marked on the document.
對于非記錄類文件（如標(biāo)準(zhǔn)操作程序）的打印副本，若僅用于參考目的，可在滿足以下條件的前提下免除核對要求：文件在生成時已標(biāo)注時間戳，并明確標(biāo)示其短期有效期限。
Potential risk of not meeting expectations/items to be checked未滿足要求的潛在風(fēng)險/待檢查項(xiàng)目
Without the use of security measures, there is a risk that rewriting or falsification of data may be made after photocopying or scanning the template record (which gives the user another template copy to use).
若不采取安全措施，在復(fù)印或掃描模板記錄后（這會為用戶提供另一份可使用的模板副本），將存在重寫或偽造數(shù)據(jù)的風(fēng)險。
Obsolete versions can be used intentionally or by error.可能故意或錯誤地使用過時版本。
A filled record with an anomalous data entry could be replaced by a new rewritten template.一份包含異常數(shù)據(jù)錄入的已填寫記錄，可能會被一份新的、經(jīng)過重寫的模板所替換。
All unused forms should be accounted for, and either defaced and destroyed, or returned for secure filing.
所有未使用的表格均需清點(diǎn)，或劃掉銷毀，或返還歸檔。
Check that (where used) reference copies of documents are clearly marked with the date of generation, period of validity and clear indication that they are for reference only and not an official copy, e.g. marked ‘uncontrolled when printed.
檢查（如適用）文件的參考副本是否已清晰標(biāo)記生成日期、有效期，并明確標(biāo)明其僅作參考而非正式副本，例如標(biāo)記“打印時不受控”。
8.4.1 An index of all authorised master documents, (SOP’s, forms, templates and records) should be maintained within the Pharmaceutical Quality System. This index should mention for each type of template record at least the following information: title, identifier including version number, location (e.g. documentation database, effective date, next review date, etc.).
應(yīng)在藥品質(zhì)量體系內(nèi)維護(hù)所有批準(zhǔn)主文件（SOP、表格、模板和記錄）的索引。該索引應(yīng)至少為每類模板記錄注明以下信息：標(biāo)題、包含版本號的標(biāo)識符、存放位置（例如：文件數(shù)據(jù)庫、生效日期、下次審核日期等）。
8.5 Use and control of records located at the point-of-use使用點(diǎn)記錄的使用與控制
8.5.1 Records should be available to operators at the point-of-use and appropriate controls should be in place to manage these records. These controls should be carried out to minimize the risk of damage or loss of the records and ensure data integrity. Where necessary, measures should be taken to protect records from being soiled (e.g. getting wet or stained by materials, etc.).
記錄應(yīng)在使用點(diǎn)可供操作人員取用，并應(yīng)建立適當(dāng)?shù)目刂拼胧﹣砉芾磉@些記錄。實(shí)施這些控制措施是為了最大限度地減少記錄損壞或丟失的風(fēng)險，并確保數(shù)據(jù)完整性。必要時，應(yīng)采取保護(hù)措施防止記錄被污染（例如被物料弄濕或弄臟等）。
8.5.2 Records should be appropriately controlled in these areas by designated persons or processes in accordance with written procedures.
上述區(qū)域的記錄應(yīng)由指定人員或通過經(jīng)批準(zhǔn)的流程，依據(jù)書面程序?qū)嵤┯行Э刂啤?/span>
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