{"id":77482,"date":"2018-12-18T00:00:50","date_gmt":"2019-02-01T06:06:23","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/77482\/"},"modified":"2019-02-01T14:06:39","modified_gmt":"2019-02-01T06:06:39","slug":"59da771a50","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/77482\/","title":{"rendered":"FDA\u6307\u5357\uff1a\u300a\u6570\u636e\u5b8c\u6574\u6027\u548cGMP\u7b26\u5408\u6027\u95ee\u7b54\u300b-2018\u7ec8\u7a3f\uff08\u4e2d\u82f1\u6587\u5bf9\u7167\u7248\uff09"},"content":{"rendered":"
\n

 <\/span>\u258d<\/span><\/strong><\/span><\/strong><\/span><\/strong>\u6765\u6e90\uff1aJulia\u7ffb\u8bd1<\/span><\/p>\n


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\"FDA\u6307\u5357\uff1a\u300a\u6570\u636e\u5b8c\u6574\u6027\u548cGMP\u7b26\u5408\u6027\u95ee\u7b54\u300b-2018\u7ec8\u7a3f\uff08\u4e2d\u82f1\u6587\u5bf9\u7167\u7248\uff09\"<\/p>\n


<\/p>\n

Data Integrity and Compliance With Drug CGMP Questions and Answers
Guidance for Industry1
\u884c\u4e1a\u6307\u5357\uff1a\u6570\u636e\u5b8c\u6574\u6027\u4e0e\u836f\u54c1CGMP\u5408\u89c4\u95ee\u7b54<\/p>\n


<\/p>\n

2018\u5e7412\u670812\u65e5\uff0cFDA\u53d1\u5e03\u4e86\u884c\u4e1a\u6307\u5357\u300a<\/span>Data Integrity and Compliance With Drug CGMP\u6570\u636e\u5b8c\u6574\u6027\u548cGMP\u7b26\u5408\u6027\u95ee\u7b54<\/span>\u300b\u7ec8\u7a3f\uff0c\u671f\u4e2d\u5305\u62ec18\u4e2a\u95ee\u9898\u7684\u89e3\u7b54\uff0c\u5982\u4e0b\uff1a<\/span><\/p>\n

    \n
  1. \n

    Please clarify the following terms as they relate to CGMP records: \u8bf7\u6f84\u6e05\u4ee5\u4e0b\u672f\u8bed\u5728\u7528\u4e8eCGMP\u8bb0\u5f55\u65f6\u7684\u542b\u4e49
    a. What is \u201cdata integrity\u201d? \u4ec0\u4e48\u662f\u201c\u6570\u636e\u5b8c\u6574\u6027\u201d\uff1f
    For the purposes of this guidance, data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA)5.
    \u672c\u6307\u5357\u4e2d\uff0c\u6570\u636e\u5b8c\u6574\u6027\u6307\u5357\u6570\u636e\u7684\u5b8c\u6574\u6027\u3001\u4e00\u81f4\u6027\u548c\u51c6\u786e\u6027\u3002\u5b8c\u6574\u3001\u4e00\u81f4\u548c\u51c6\u786e\u7684\u6570\u636e\u5e94\u53ef\u8ffd\u6eaf\u3001\u6e05\u6670\u3001\u540c\u6b65\u8bb0\u5f55\u3001\u4e3a\u539f\u4ef6\u6216\u771f\u5b9e\u526f\u672c\u5e76\u51c6\u786e\uff08ALCOA\uff09\u3002
    Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archival, retrieval, transmission, and disposition of data after the record\u2019s retention period ends6. System design and controls should enable easy detection of errors, omissions, and aberrant results throughout the data\u2019s life cycle.
    \u6570\u636e\u5b8c\u6574\u6027\u5728\u6574\u4e2aCGMP\u6570\u636e\u751f\u547d\u5468\u671f\u4e2d\u90fd\u5f88\u5173\u952e\uff0c\u5305\u62ec\u6570\u636e\u7684\u521b\u5efa\u3001\u4fee\u6539\u3001\u5904\u7406\u3001\u4fdd\u5b58\u3001\u5f52\u6863\u3001\u4f20\u8f93\u548c\u8d85\u4fdd\u5b58\u671f\u540e\u7684\u5904\u7f6e\u3002\u7cfb\u7edf\u8bbe\u8ba1\u548c\u63a7\u5236\u5e94\u4f7f\u5176\u5728\u6574\u4e2a\u6570\u636e\u751f\u547d\u5468\u671f\u4e2d\u6613\u4e8e\u53d1\u73b0\u9519\u8bef\u3001\u9057\u6f0f\u548c\u5f02\u5e38\u7ed3\u679c\u3002<\/p>\n

    b. What is \u201cmetadata\u201d? \u4ec0\u4e48\u662f\u201c\u5143\u6570\u636e\u201d\uff1f
    Metadata is the contextual information required to understand data. A data value is by itself meaningless without additional information about the data. Metadata is often described as data about data. Metadata is structured information that describes, explains, or otherwise makes it easier to retrieve, use, or manage data. For example, the number \u201c23\u201d is meaningless without metadata, such as an indication of the unit \u201cmg.\u201d Among other things, metadata for a particular piece of data could include a date\/time stamp documenting when the data were acquired, a user ID of the person who conducted the test or analysis that generated the data, the instrument ID used to acquire the data, material status data, the material identification number, and audit trails.
    \u5143\u6570\u636e\u662f\u4e86\u89e3\u6570\u636e\u6240\u9700\u7684\u73af\u5883\u4fe1\u606f\u3002\u5982\u679c\u6ca1\u6709\u5173\u4e8e\u6570\u636e\u7684\u5176\u5b83\u4fe1\u606f\uff0c\u4e00\u4e2a\u6570\u636e\u503c\u81ea\u8eab\u662f\u6ca1\u6709\u610f\u4e49\u7684\u3002\u5143\u6570\u636e\u901a\u5e38\u88ab\u63cf\u8ff0\u4e3a\u6570\u636e\u7684\u6570\u636e\u3002\u5143\u6570\u636e\u662f\u7ed3\u6784\u5f0f\u7684\u4fe1\u606f\uff0c\u5b83\u63cf\u8ff0\u3001\u89e3\u91ca\u6570\u636e\u6216\u4f7f\u5f97\u6570\u636e\u6613\u4e8e\u68c0\u7d22\u3001\u4f7f\u7528\u6216\u7ba1\u7406\u3002\u4f8b\u5982\uff0c\u6570\u503c\u201c23\u201d\u5982\u679c\u6ca1\u6709\u5143\u6570\u636e\u4f8b\u5982\u663e\u793a\u5355\u4f4d\u201cmg\u201d\u662f\u6ca1\u6709\u610f\u4e49\u7684\u3002\u6b64\u5916\uff0c\u5143\u6570\u636e\u662f\u4e00\u79cd\u7279\u522b\u7684\u6570\u636e\uff0c\u53ef\u5305\u62ec\u65e5\u671f\u65f6\u95f4\u6233\u4ee5\u8bb0\u5f55\u6570\u636e\u662f\u4f55\u65f6\u91c7\u96c6\u7684\u3001\u7528\u6237ID\u8bf4\u660e\u662f\u8c01\u6267\u884c\u4e86\u68c0\u6d4b\u6216\u5206\u6790\u4ece\u800c\u751f\u6210\u8be5\u6570\u636e\u3001\u7528\u4e8e\u91c7\u96c6\u6570\u636e\u7684\u4eea\u5668ID\u3001\u539f\u6599\u72b6\u6001\u6570\u636e\u3001\u539f\u6599\u8bc6\u522b\u53f7\u548c\u5ba1\u8ba1\u8ffd\u8e2a\u3002
    Data should be maintained throughout the record\u2019s retention period with all associated metadata required to reconstruct the CGMP activity (e.g., \u00a7\u00a7 211.188 and 211.194). The relationships between data and their metadata should be preserved in a secure and traceable manner.
    \u5728\u8bb0\u5f55\u7684\u6574\u4e2a\u4fdd\u5b58\u671f\u95f4\uff0c\u5e94\u5c06\u91cd\u5efaCGMP\u6d3b\u52a8\u6240\u9700\u7684\u76f8\u5173\u5143\u6570\u636e\u4e0e\u6570\u636e\u4e00\u8d77\u4fdd\u5b58\uff08\u4f8b\u5982\u00a7\u00a7 211.188 \u548c211.194\uff09\u3002\u6570\u636e\u4e0e\u5176\u5143\u6570\u636e\u4e4b\u95f4\u7684\u5173\u7cfb\u5e94\u4ee5\u5b89\u5168\u548c\u53ef\u8ffd\u6eaf\u7684\u65b9\u5f0f\u4fdd\u7559\u3002
    c. What is an \u201caudit trail\u201d? \u4ec0\u4e48\u662f\u201c\u5ba1\u8ba1\u8ffd\u8e2a\u201d\uff1f
    For purposes of this guidance, audit trail means a secure, computer-generated, time-stamped electronic record that allows for reconstruction of the course of events relating to the creation, modification, or deletion of an electronic record. For example, the audit trail for a high performance liquidchromatography (HPLC) run should include the user name, date\/time of the run, the integration parameters used, and details of a reprocessing, if any. Documentation should include change justification for the reprocessing.
    \u5728\u672c\u6307\u5357\u4e2d\uff0c\u5ba1\u8ba1\u8ffd\u8e2a\u610f\u6307\u4e00\u79cd\u5b89\u4fdd\u7528\u3001\u7531\u8ba1\u7b97\u673a\u751f\u6210\u5e26\u6709\u65f6\u95f4\u6233\u7684\u7535\u5b50\u8bb0\u5f55\uff0c\u5b83\u4f7f\u5f97\u53ef\u4ee5\u91cd\u6784\u4e0e\u4e00\u4e2a\u7535\u5b50\u8bb0\u5f55\u521b\u5efa\u3001\u4fee\u6539\u6216\u5220\u9664\u6709\u5173\u7684\u4e8b\u4ef6\u7684\u8fc7\u7a0b\u3002\u4f8b\u5982\uff0cHPLC\u8fd0\u884c\u7684\u5ba1\u8ba1\u8ffd\u8e2a\u5e94\u5305\u62ec\u6709\u7528\u6237\u540d\u3001\u8fd0\u884c\u65e5\u671f\u65f6\u95f4\u3001\u6240\u7528\u79ef\u5206\u53c2\u6570\u4ee5\u53ca\u91cd\u65b0\u5904\u7406\u7684\u8be6\u7ec6\u4fe1\u606f\uff08\u5982\u6709\uff09\u3002\u6587\u4ef6\u8bb0\u5f55\u5e94\u5305\u62ec\u6709\u91cd\u65b0\u5904\u7406\u7684\u53d8\u66f4\u8bba\u8bc1\u3002
    Audit trails include those that track creation, modification, or deletion of data (such as processing parameters and results) and those that track actions at the record or system level (such as attempts to access the system or rename or delete a file).
    \u5ba1\u8ba1\u8ffd\u8e2a\u5305\u62ec\u8ffd\u8e2a\u6570\u636e\u521b\u5efa\u3001\u4fee\u6539\u6216\u5220\u9664\uff08\u5982\u5904\u7406\u53c2\u6570\u548c\u7ed3\u679c\uff09\u7684\u4fe1\u606f\uff0c\u548c\u8ffd\u8e2a\u8bb0\u5f55\u6216\u7cfb\u7edf\u5c42\u7ea7\u52a8\u4f5c\u7684\u4fe1\u606f\uff08\u5982\u8bd5\u56fe\u8bbf\u95ee\u7cfb\u7edf\u6216\u91cd\u547d\u540d\u6216\u5220\u9664\u4e00\u4efd\u6587\u4ef6\uff09\u3002
    CGMP-compliant record-keeping practices prevent data from being lost or obscured and ensure that activities are documented at the time of performance (see \u00a7\u00a7 211.68, 211.100, 211.160(a), 211.188, and 211.194). Electronic record-keeping systems, which include audit trails, can support these CGMP requirements.
    \u7b26\u5408CGMP\u8981\u6c42\u7684\u8bb0\u5f55\u4fdd\u5b58\u89c4\u8303\u9632\u6b62\u6570\u636e\u4e22\u5931\u6216\u906e\u76d6\uff0c\u786e\u4fdd\u6d3b\u52a8\u5728\u6267\u884c\u65f6\u5373\u88ab\u8bb0\u5f55\uff08\u53c2\u89c1\u00a7\u00a7 211.68, 211.100, 211.160(a), 211.188\u548c211.194\uff09\u3002\u542b\u6709\u5ba1\u8ba1\u8ffd\u8e2a\u7684\u7535\u5b50\u8bb0\u5f55\u4fdd\u5b58\u7cfb\u7edf\u53ef\u652f\u6301\u8fd9\u4e9bCGMP\u8981\u6c42\u3002<\/p>\n

    d. How does FDA use the terms \u201cstatic\u201d and \u201cdynamic\u201d as they relate to record formats? FDA\u5728\u8bb0\u5f55\u683c\u5f0f\u65b9\u9762\u662f\u5982\u4f55\u4f7f\u7528\u672f\u8bed\u201c\u9759\u6001\u201d\u548c\u201c\u52a8\u6001\u201d\u7684\uff1f
    For the purposes of this guidance, static is used to indicate a fixed-data record such as a paper record or an electronic image, and dynamic means that the record format allows interaction between the user and the record content. For example, a dynamic chromatographic record may allow the user to change the baseline and reprocess chromatographic data so that the resulting peaks may appear smaller or larger. It also may allow the user to modify formulas or entries in a spreadsheet used to compute test results or other information such as calculated yield.
    \u5728\u672c\u6307\u5357\u4e2d\uff0c\u9759\u6001\u7528\u4e8e\u8868\u793a\u6570\u636e\u56fa\u5316\u7684\u8bb0\u5f55\uff0c\u5982\u7eb8\u8d28\u8bb0\u5f55\u6216\u7535\u5b50\u56fe\u50cf\uff0c\u800c\u52a8\u6001\u5219\u8868\u793a\u8bb0\u5f55\u683c\u5f0f\u5141\u8bb8\u7528\u6237\u4e0e\u8bb0\u5f55\u5185\u5bb9\u8fdb\u884c\u4e92\u52a8\uff0c\u4f8b\u5982\uff0c\u52a8\u6001\u8272\u8c31\u8bb0\u5f55\u5141\u8bb8\u7528\u6237\u6539\u53d8\u57fa\u7ebf\uff0c\u91cd\u65b0\u5904\u7406\u8272\u8c31\u6570\u636e\uff0c\u8fd9\u6837\u5f97\u5230\u7684\u5cf0\u770b\u8d77\u6765\u4f1a\u66f4\u5c0f\u6216\u66f4\u5927\u3002\u5b83\u4ea6\u53ef\u5141\u8bb8\u7528\u6237\u4fee\u6539\u7528\u4e8e\u8ba1\u7b97\u68c0\u6d4b\u7ed3\u679c\u7684\u6570\u636e\u8868\u4e2d\u7684\u516c\u5f0f\u6216\u5f55\u5165\u6570\u5b57\uff0c\u6216\u5176\u5b83\u4fe1\u606f\u5982\u8ba1\u7b97\u7ed3\u679c\u3002e. How does FDA use the term \u201cbackup\u201d in \u00a7 211.68(b)? FDA\u662f\u5982\u4f55\u4f7f\u7528\u00a7 211.68(b)\u4e2d\u7684\u672f\u8bed\u201c\u5907\u4efd\u201d\u7684\uff1f
    FDA uses the term backup in \u00a7 211.68(b) to refer to a true copy of the original record that is maintained securely throughout the record retention period (e.g., \u00a7 211.180). Backup data must be exact, complete, and secure from alteration, inadvertent erasures, or loss (\u00a7 211.68(b)). The backup file should contain the data (which includes associated metadata) and should be in the original format or in a format compatible with the original format.
    FDA\u5728\u00a7 211.68(b)\u4f7f\u7528\u4e86\u672f\u8bed\u5907\u4efd\u7528\u4e8e\u501f\u6307\u5728\u6574\u4e2a\u8bb0\u5f55\u4fdd\u5b58\u671f\u5185\u5b89\u5168\u4fdd\u5b58\u7684\u539f\u59cb\u8bb0\u5f55\u7684\u771f\u5b9e\u526f\u672c\uff08\u4f8b\u5982\u00a7 211.180\uff09\u3002\u5907\u4efd\u6570\u636e\u5fc5\u987b\u51c6\u786e\u3001\u5b8c\u6574\uff0c\u5b89\u5168\u4e0d\u4f1a\u88ab\u4fee\u6539\u3001\u65e0\u610f\u64e6\u9664\u6216\u4e22\u5931\uff08\u00a7 211.68(b)\uff09\u3002\u5907\u4efd\u6587\u4ef6\u5e94\u542b\u6709\u6570\u636e\uff08\u5176\u4e2d\u5305\u62ec\u76f8\u5173\u5143\u6570\u636e\uff09\uff0c\u5e76\u5e94\u91c7\u7528\u539f\u59cb\u683c\u5f0f\u6216\u4e0e\u539f\u59cb\u683c\u5f0f\u517c\u5bb9\u7684\u683c\u5f0f\u3002
    FDA\u2019s use of the term backup is consistent with the term archive as used in guidance for industry and FDA staff General Principles of Software Validation.
    FDA\u5bf9\u672f\u8bed\u5907\u4efd\u7684\u4f7f\u7528\u4e0e\u884c\u4e1a\u6307\u5357\u548cFDA\u8f6f\u4ef6\u9a8c\u8bc1\u5458\u5de5\u901a\u5219\u4e2d\u6240\u7528\u7684\u672f\u8bed\u5f52\u6863\u5177\u6709\u76f8\u540c\u610f\u601d\u3002
    Temporary backup copies (e.g., in case of a computer crash or other interruption) would not satisfy the requirement in \u00a7 211.68(b) to maintain a backup file of data.
    \u4e34\u65f6\u5907\u4efd\u526f\u672c\uff08\u4f8b\u5982\uff0c\u5982\u679c\u8ba1\u7b97\u673a\u6b7b\u673a\u6216\u5176\u5b83\u4e2d\u65ad\uff09\u4e0d\u80fd\u6ee1\u8db3\u00a7 211.68(b)\u7684\u4fdd\u5b58\u6570\u636e\u5907\u4efd\u6587\u4ef6\u8981\u6c42\u3002
    f. What are the \u201csystems\u201d in \u201ccomputer or related systems\u201d in \u00a7 211.68? \u00a7 211.68 \u91cc\u9762\u201c\u8ba1\u7b97\u673a\u6216\u76f8\u5173\u7cfb\u7edf\u201d\u4e2d\u7684\u201c\u7cfb\u7edf\u201d\u662f\u4ec0\u4e48\uff1f
    The American National Standards Institute (ANSI) defines systems as people, machines, and methods organized to accomplish a set of specific functions7. Computer or related systems can refer to computer hardware, software, peripheral devices, networks, cloud infrastructure, personnel, and associated documents (e.g., user manuals and standard operating procedures8).
    \u7f8e\u56fd\u56fd\u5bb6\u6807\u51c6\u7814\u7a76\u6240\uff08ANSI\uff09\u5b9a\u4e49\u7cfb\u7edf\u4e3a\u7ec4\u7ec7\u8d77\u6765\u5b8c\u6210\u4e00\u7cfb\u5217\u6307\u5b9a\u529f\u80fd\u7684\u4eba\u5458\u3001\u673a\u5668\u548c\u65b9\u6cd5\u3002\u8ba1\u7b97\u673a\u6216\u76f8\u5173\u7cfb\u7edf\u53ef\u4ee3\u6307\u8ba1\u7b97\u673a\u786c\u4ef6\u3001\u8f6f\u4ef6\u3001\u5916\u56f4\u8bbe\u5907\u3001\u7f51\u7edc\u3001\u4e91\u57fa\u7840\u8bbe\u65bd\u3001\u4eba\u5458\u548c\u76f8\u5173\u6587\u4ef6\uff08\u4f8b\u5982\u7528\u6237\u624b\u518c\u548c\u6807\u51c6\u64cd\u4f5c\u89c4\u7a0b\uff09\u3002<\/p>\n

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    <\/p>\n


    <\/p>\n<\/li>\n<\/ol>\n

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