{"id":20837,"date":"2018-07-18T01:00:00","date_gmt":"2018-08-08T01:21:46","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/08\/08\/pda%e6%80%9d%e8%80%83%ef%bc%9agmp%e8%bf%8e%e6%a3%80%ef%bc%8c%e9%9d%9egmp%e5%86%85%e5%ae%b9%e4%bd%a0%e4%b9%9f%e5%87%86%e5%a4%87%e5%a5%bd%e4%ba%86%e4%b9%88%ef%bc%9f\/"},"modified":"2018-08-08T09:21:48","modified_gmt":"2018-08-08T01:21:48","slug":"pda%e6%80%9d%e8%80%83%ef%bc%9agmp%e8%bf%8e%e6%a3%80%ef%bc%8c%e9%9d%9egmp%e5%86%85%e5%ae%b9%e4%bd%a0%e4%b9%9f%e5%87%86%e5%a4%87%e5%a5%bd%e4%ba%86%e4%b9%88%ef%bc%9f","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/20837\/","title":{"rendered":"PDA\u601d\u8003\uff1aGMP\u8fce\u68c0\uff0c\u975eGMP\u5185\u5bb9\u4f60\u4e5f\u51c6\u5907\u597d\u4e86\u4e48\uff1f"},"content":{"rendered":"
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\u5199\u5728\u524d\u9762\u7684\u8bdd<\/strong>\uff1a<\/span><\/p>\n

<\/span><\/p>\n

\u5728GMP<\/span>\u6982\u5ff5\u5df2\u7ecf\u9010\u6e10\u6210\u719f\u88ab\u6df1\u5165\u4eba\u5fc3\uff0cGMP\u68c0\u67e5\u5df2\u7ecf\u53ef\u4ee5\u8f7b\u677e\u9762\u5bf9\u7684\u5e74\u4ee3\uff0c\u5236\u836f\u884c\u4e1a\u5f00\u59cb\u770b\u5230\u6050\u6016\u7684\u4e00\u5e55\u62c9\u5f00\uff1a\u975eGMP\u884c\u4e3a\u3001\u8bb0\u5f55\u548c\u8bc1\u636e\u5f00\u59cb\u88ab\u7275\u6d89\u88ab\u68c0\u67e5\uff0c\u751a\u81f3\u88ab\u4f5c\u4e3a\u7f3a\u9677\u5199\u5165483\uff01GMP\u68c0\u67e5\u8fd9\u662f\u8981\u4e0a\u5929\u4e48\uff1f\u53ea\u6709\u4f60\u60f3\u4e0d\u5230\uff0c\u6ca1\u6709\u4eba\u5bb6\u67e5\u4e0d\u5230\uff01\u8ba9\u6211\u4eec\u4e00\u8d77\u5b66\u4e60\u5b66\u4e60\u77e5\u540d\u7ec4\u7ec7\u7684\u826f\u5fc3\u8bf4\u6cd5\uff08\u80fd\u4e0d\u80fd\u6d3e\u4e0a\u7528\u573a\u5c31\u770b\u4f60\u6709\u6ca1\u6709\u80c6\u91cf\u4e86\uff09\uff01<\/span><\/span><\/p>\n

\u2014\u2014\u672c\u6587\u6765\u81eaPDA 7\u670815\u65e5\u7535\u5b50\u6742\u5fd7\uff0c\u7ffb\u8bd1\u5e2e\u52a9\uff1aJulia\u6731\u7389\u5a07\uff0f<\/span><\/strong>\u539f\u6587\u5b98\u7f51\u94fe\u63a5\uff1ahttp:\/\/journal.pda.org\/content\/72\/3\/332.full.pdf+html<\/span><\/span><\/p>\n

\u2014\u2014
<\/span><\/p>\n<\/section>\n<\/section>\n

\n

<\/section>\n<\/section>\n<\/section>\n<\/section>\n

Background and Purpose <\/span><\/p>\n

\u80cc\u666f\u548c\u76ee\u7684<\/span><\/p>\n

Basedon its own experience and through a broad industry survey conducted withsupport from the Association for Accessible Medicines (AAM) and the Pharma& Biopharma Outsourcing Association (PBOA), PDA has identified current questionsrelated to data management and control that have been frequently cited in FDAinspections or have led to FDA regulatory actions. The PDA Data Integrity Task Forcehas selected eleven questions to address at this time and included recommendedbest practices for each situation. The purpose of this document is to help toclarify these issues for industry and to help facilitate better compliance bysharing PDA members\u2019 expertise in and understanding of current best practices.<\/span><\/p>\n

\u6839\u636e\u5176\u81ea\u8eab\u7ecf\u9a8c\uff0c\u901a\u8fc7\u5e7f\u6cdb\u7684\u4f01\u4e1a\u8c03\u67e5\uff0c\u5728AAM\u548cPBOA\u652f\u6301\u4e0b\uff0cPDA\u8bc6\u522b\u51fa\u4e86\u5f53\u524d\u4e0e\u6570\u636e\u7ba1\u7406\u548c\u63a7\u5236\u6709\u5173\u7684\u4e00\u4e9b\u95ee\u9898\u3002\u8fd9\u4e9b\u95ee\u9898\u66fe\u88abFDA\u68c0\u67e5\u9891\u7e41\u6307\u51fa\u6216\u5bfc\u81f4FDA\u6cd5\u89c4\u63aa\u65bd\u3002PDA\u6570\u636e\u5b8c\u6574\u6027\u5de5\u4f5c\u7ec4\u6b64\u6b21\u9009\u62e9\u4e8611\u4e2a\u95ee\u9898\u6765\u8fdb\u884c\u8bf4\u660e\uff0c\u5176\u4e2d\u5305\u62ec\u6709\u5728\u5404\u79cd\u60c5\u5f62\u4e0b\u7684\u6700\u4f73\u89c4\u8303\u5efa\u8bae\u3002\u6b64\u6587\u4ef6\u7684\u76ee\u7684\u662f\u901a\u8fc7\u5206\u4eabPDA\u6210\u5458\u7684\u4e13\u4e1a\u77e5\u8bc6\u4e0e\u5bf9\u5f53\u524d\u6700\u4f73\u89c4\u8303\u7684\u7406\u89e3\u5e2e\u52a9\u4f01\u4e1a\u6f84\u6e05\u8fd9\u4e9b\u95ee\u9898\uff0c\u5e2e\u52a9\u5de5\u5382\u66f4\u597d\u5730\u5b9e\u73b0\u5408\u89c4\u3002<\/span><\/p>\n

Dataintegrity inspectional observations by health authorities can have a severeimpact on a firm from a regulatory and public perception perspective and shouldnot result from a lack of clarity by industry about what is required. Inaddition, firms are concerned that the inability to produce a requested recordor document during an inspection, even if not a standard report or existingquality system document, could be construed as delaying, denying, limiting, orrefusing inspection, which also has significant consequences.<\/span><\/p>\n

\u836f\u76d1\u673a\u6784\u7684\u6570\u636e\u5b8c\u6574\u6027\u68c0\u67e5\u7f3a\u9677\u5728\u6cd5\u89c4\u548c\u516c\u4f17\u89c2\u5ff5\u65b9\u9762\u53ef\u80fd\u4f1a\u6709\u5f88\u4e25\u91cd\u7684\u5f71\u54cd\uff0c\u4e0d\u5e94\u8be5\u662f\u7531\u4e8e\u4f01\u4e1a\u7f3a\u4e4f\u5bf9\u6240\u9700\u5de5\u4f5c\u7684\u4e86\u89e3\u800c\u9020\u6210\u3002\u53e6\u5916\uff0c\u5728\u68c0\u67e5\u671f\u95f4\uff0c\u4f01\u4e1a\u6ca1\u6709\u80fd\u529b\u751f\u6210\u6240\u9700\u8bb0\u5f55\u6216\u6587\u4ef6\u4f1a\u53d7\u5230\u5173\u5207\uff0c\u5373\u4f7f\u4e0d\u662f\u6807\u51c6\u62a5\u544a\u6216\u73b0\u5b58\u8d28\u91cf\u4f53\u7cfb\u6587\u4ef6\uff0c\u8fd9\u53ef\u80fd\u4f1a\u6784\u6210\u62d6\u5ef6\u3001\u5426\u51b3\u3001\u9650\u5236\u6216\u62d2\u7edd\u68c0\u67e5\uff0c\u8fd9\u4e5f\u4f1a\u4ea7\u751f\u4e25\u91cd\u540e\u679c\u3002<\/span><\/p>\n


<\/span><\/p>\n

Question 1: Copies of GMP Records<\/span><\/p>\n

\u95ee<\/span>1\uff1a<\/span>GMP\u8bb0\u5f55\u526f\u672c<\/span><\/span><\/p>\n

Context: \u80cc\u666f<\/span><\/p>\n

Ona daily basis, there are many valid reasons why a firm may wish to make copiesof GMP records, including records that contain a lot number, batch-specificdata, test results, or other data. For example, firms may make a copy of abatch record to provide to a Technical Services group to conduct aninvestigation. Especially in light of recent 483 observations that highlightdocuments with batch information found in a shredder, it is unclear under whatconditions it is permissible to treat copies of GMP records as uncontrolled,non-GMP records. Requiring that the issuance, management, and destruction ofall of these documents be controlled by the Quality Unit imposes an unnecessaryburden on industry. The key is for firms to be able to show how they assurethat an original record is the original re<\/span>cord and that the data in the recordsatisfy ALCOA principles.<\/span><\/p>\n

\u5728\u65e5\u5e38\u5de5\u4f5c\u4e2d\uff0c\u516c\u53f8\u6709\u8bb8\u591a\u5408\u7406\u7406\u7531\u60f3\u8981\u590d\u5236GMP\u8bb0\u5f55\uff0c\u5305\u62ec\u542b\u6709\u6279\u53f7\u3001\u6279\u7279\u5b9a\u6570\u636e\u3001\u68c0\u9a8c\u7ed3\u679c\u6216\u5176\u5b83\u6570\u636e\u7684\u8bb0\u5f55\u3002\u4f8b\u5982\uff0c\u516c\u53f8\u53ef\u80fd\u4f1a\u590d\u5370\u4e00\u4efd\u6279\u8bb0\u5f55\uff0c\u63d0\u4f9b\u7ed9\u6280\u672f\u670d\u52a1\u7ec4\u6267\u884c\u4e00\u4e2a\u8c03\u67e5\u3002\u5c24\u5176\u662f\u5728\u6700\u8fd1\u7684483\u7f3a\u9677\u4e2d\uff0c\u91cd\u70b9\u5f3a\u8c03\u4e86\u5728\u4e00\u4e2a\u788e\u7eb8\u673a\u4e2d\u53d1\u73b0\u6709\u6279\u4fe1\u606f\u7684\u6587\u4ef6\uff0c\u7136\u540e\u5e76\u4e0d\u6e05\u695a\u662f\u5728\u4f55\u79cd\u60c5\u51b5\u4e0b\u5141\u8bb8\u5c06GMP\u8bb0\u5f55\u7684\u526f\u672c\u4f5c\u4e3a\u975e\u53d7\u63a7\u3001\u975eGMP\u8bb0\u5f55\u5bf9\u5f85\u3002\u8981\u6c42\u5c06\u6240\u6709\u8fd9\u4e9b\u6587\u4ef6\u7684\u7b7e\u53d1\u3001\u7ba1\u7406\u548c\u9500\u6bc1\u90fd\u53d7\u8d28\u91cf\u90e8\u95e8\u63a7\u5236\u4f1a\u7ed9\u4f01\u4e1a\u5e26\u6765\u4e0d\u5fc5\u8981\u7684\u8d1f\u62c5\u3002\u5173\u952e\u7684\u662f\u516c\u53f8\u8981\u80fd\u663e\u793a\u51fa\u4ed6\u4eec\u662f\u5982\u4f55\u786e\u4fdd\u539f\u59cb\u8bb0\u5f55\u662f\u539f\u59cb\u8bb0\u5f55\uff0c\u5e76\u4e14\u8bb0\u5f55\u4e2d\u7684\u6570\u636e\u6ee1\u8db3ALCOA\u539f\u5219\u3002<\/span><\/p>\n

Issue: Is a copy of a GMPrecord (e.g. printout of the raw data or photocopy\/scan of a paper originalrecord) itself considered a GMP document? <\/span><\/p>\n


<\/span><\/p>\n

\u95ee\uff1aGMP\u8bb0\u5f55\u7684\u526f\u672c\uff08\u4f8b\u5982\uff0c\u539f\u59cb\u6570\u636e\u7684\u6253\u5370\u4ef6\u6216\u7eb8\u8d28\u539f\u59cb\u8bb0\u5f55\u7684\u5f71\u5370\u4ef6\/\u626b\u63cf\u4ef6\uff09\u81ea\u8eab\u5c31\u88ab\u8ba4\u4e3a\u4e00\u4efdGMP\u6587\u4ef6\u5417\uff1f<\/span><\/p>\n

Clarification:As long as firms have full control over original GMP documents and the originalGMP document is retained as required by the firm\u2019s procedure, copies can becreated and destroyed as needed. A copy of a GMP record need only be retainedif additional GMP information (e.g., raw data) is recorded on the document copy. As a partof maintaining control over GMP records, it is advisable to make sure thatcopies can be readily distinguished from originals (e.g., copies are stamped as\u201ccopy\u201d and\/or originals are stamped as \u201coriginal\u201d).<\/span><\/p>\n

\u6f84\u6e05\uff1a\u53ea\u8981\u516c\u53f8\u5bf9\u539f\u59cbGMP\u6587\u4ef6\u6709\u5168\u9762\u63a7\u5236\uff0c\u5e76\u4e14\u539f\u59cbGMP\u6587\u4ef6\u6309\u516c\u53f8\u7a0b\u5e8f\u4fdd\u5b58\uff0c\u5728\u9700\u8981\u65f6\u53ef\u4ee5\u521b\u5efa\u548c\u9500\u6bc1\u526f\u672c\u3002\u4e00\u4efdGMP\u8bb0\u5f55\u7684\u526f\u672c\u53ea\u6709\u5f53\u5728\u5176\u4e0a\u8bb0\u5f55\u4e86\u5176\u5b83GMP\u4fe1\u606f\uff08\u4f8b\u5982\uff0c\u539f\u59cb\u6570\u636e\uff09\u65f6\u624d\u9700\u8981\u4fdd\u5b58\u3002\u4f5c\u4e3a\u5bf9GMP\u8bb0\u5f55\u4fdd\u5b58\u63a7\u5236\u7684\u4e00\u90e8\u5206\uff0c\u5efa\u8bae\u786e\u4fdd\u526f\u672c\u53ef\u4ee5\u6613\u4e8e\u4e0e\u539f\u59cb\u4ef6\u533a\u5206\uff08\u4f8b\u5982\uff0c\u526f\u672c\u52a0\u76d6\u201c\u590d\u5370\u4ef6\u201d\u7ae0\u548c\/\u6216\u539f\u4ef6\u52a0\u76d6\u201c\u539f\u4ef6\u201d\u7ae0\uff09\u3002<\/span><\/p>\n


<\/span><\/p>\n

Question 2: Documents not traditionally considered GMPrecords <\/span>
\u95ee\u9898<\/span>2\uff1a\u6587\u4ef6\u5e76\u975e\u4f20\u7edf\u610f\u4e49\u7684<\/span>GMP\u8bb0\u5f55<\/span><\/span><\/span><\/p>\n

Context:  \u80cc\u666f<\/span><\/p>\n

In recent483s, we have observed that documents not traditionally considered GMP records(e.g., e-mails and other communications) become the object of scrutiny andobservations. A working definition of what the agency currently views as a GMPrecord for such things as e-mail, supervisor schedule, etc. would be helpfulfor industry. Firms communicate informally about production and quality-relatedactivities on a continuing basis in order to facilitate operations. An e-mailregarding batch release may be essentially the written equivalent of a phonecall from one colleague to another stating that a batch has been released.Requiring formal controls around all of these documents, or requiring that suchdocuments cannot be printed and discarded\/destroyed\/shredded at will, creates alarge burden on firms and their quality units.<\/span><\/p>\n

\u80cc\u666f\uff1a\u5728\u6700\u8fd1\u7684483\u4e2d\uff0c\u6211\u4eec\u53d1\u73b0\u4f20\u7edf\u4e0a\u5e76\u4e0d\u8ba4\u4e3a\u662fGMP\u8bb0\u5f55\u7684\u6587\u4ef6\uff08\u4f8b\u5982\uff0c\u7535\u5b50\u90ae\u4ef6\u548c\u5176\u5b83\u901a\u8baf\u4fe1\u606f\uff09\u6210\u4e3a\u4e86\u76d1\u7763\u548c\u7f3a\u9677\u7684\u5bf9\u8c61\u3002\u5b98\u65b9\u76ee\u524d\u5c06\u4f55\u79cd\u6587\u4ef6\u89c6\u4e3aGMP\u8bb0\u5f55\uff08\u5982\u7535\u5b50\u90ae\u4ef6\u3001\u4e3b\u7ba1\u65e5\u7a0b\u7b49\uff09\u5982\u679c\u6709\u4e00\u4e2a\u5de5\u4f5c\u5b9a\u4e49\uff0c\u5c06\u5bf9\u4f1a\u4f01\u4e1a\u5927\u6709\u5e2e\u52a9\u3002\u4e3a\u4e86\u4fbf\u4e8e\u8fd0\u8425\uff0c\u516c\u53f8\u4f1a\u6301\u7eed\u6c9f\u901a\u5173\u4e8e\u751f\u4ea7\u548c\u8d28\u91cf\u6d3b\u52a8\u7684\u8baf\u606f\u3002\u4e00\u4efd\u5173\u4e8e\u6279\u653e\u884c\u7684\u7535\u5b50\u90ae\u4ef6\u53ef\u80fd\u57fa\u672c\u4e0a\u7b49\u540c\u4e8e\u4e00\u4f4d\u540c\u4e8b\u5411\u53e6\u4e00\u4f4d\u540c\u4e8b\u8bf4\u660e\u4e00\u4e2a\u6279\u6b21\u5df2\u653e\u884c\u7684\u4e66\u9762\u5f62\u5f0f\u3002\u8981\u6c42\u6b63\u5f0f\u63a7\u5236\u6240\u6709\u8fd9\u4e9b\u6587\u4ef6\uff0c\u6216\u8981\u6c42\u6b64\u7c7b\u6587\u4ef6\u4e0d\u80fd\u4efb\u610f\u6253\u5370\u51fa\u6765\u548c\u4e22\u5f03\/\u9500\u6bc1\/\u788e\u6389\uff0c\u4f1a\u5bf9\u516c\u53f8\u53ca\u5176\u8d28\u91cf\u90e8\u95e8\u9020\u6210\u5f88\u5927\u8d1f\u62c5\u3002<\/span><\/p>\n

Issue: Are e-mails or other papersthat contain batch-related information such as product name, lot number, ortest results considered GMP records if local procedures are clear on what isthe system of record?<\/span><\/p>\n

\u95ee\uff1a\u5982\u679c\u516c\u53f8\u7684\u7a0b\u5e8f\u975e\u5e38\u6e05\u695a\u89c4\u5b9a\u4e86\u8bb0\u5f55\u7cfb\u7edf\u662f\u4ec0\u4e48\uff0c\u7535\u5b50\u90ae\u4ef6\u6216\u5176\u5b83\u542b\u6709\u6279\u76f8\u5173\u4fe1\u606f\u5982\u54c1\u540d\u3001\u6279\u53f7\u6216\u68c0\u6d4b\u7ed3\u679c\u7684\u7eb8\u5f20\u4f1a\u88ab\u8ba4\u4e3a\u662fGMP\u8bb0\u5f55\u5417\uff1f<\/span><\/p>\n

Clarification:Whether a document is considered a GMP record depends on whether it is generatedto satisfy a GMP requirement (see Data Integrity and Compliance with CGMP,Guidance for Industry, April 2016 draft, \u201cWhen generated to satisfy a CGMPrequirement, all data become a CGMP record.\u201d) For example, if e-mail is used asa record of batch release, it is a GMP document. If e-mail is used tocommunicate that a batch has been released, but the system of record for batchrelease is not e-mail, then the e-mail is not a GMP record. Similarly, draftsof risk assessments, investigation reports, etc. are not cGMP records untilthey have been reviewed and finalized. If companies use e-mails for GMPpurposes, it is advisable to have a controlled process, governed by an SOP.<\/span><\/p>\n

\u6f84\u6e05\uff1a\u4e00\u4efd\u6587\u4ef6\u662f\u5426\u88ab\u8ba4\u4e3a\u662fGMP\u8bb0\u5f55\u53d6\u51b3\u4e8e\u5176\u751f\u6210\u662f\u5426\u4e3a\u4e86\u6ee1\u8db3\u4e00\u4e2aGMP\u9700\u6c42\uff08\u53c2\u89c1\u884c\u4e1a\u6307\u5357\uff1a\u6570\u636e\u5b8c\u6574\u6027\u548cCGMP\u5408\u89c4\u6027\uff0c2016\u5e744\u6708\u8349\u6848\uff0c\u201c\u6240\u6709\u4e3a\u4e86\u6ee1\u8db3CGMP\u8981\u6c42\u800c\u751f\u6210\u7684\u6570\u636e\u5747\u4e3aCGMP\u8bb0\u5f55\u201d\uff09\u3002\u4f8b\u5982\uff0c\u5982\u679c\u4e00\u5c01\u7535\u5b50\u90ae\u4ef6\u88ab\u7528\u6765\u4f5c\u4e3a\u6279\u653e\u884c\u7684\u8bb0\u5f55\uff0c\u5219\u5176\u5c31\u662f\u4e00\u4efdGMP\u6587\u4ef6\u3002\u5982\u679c\u7535\u5b50\u90ae\u4ef6\u7528\u4e8e\u6c9f\u901a\u4e00\u6279\u5df2\u88ab\u653e\u884c\uff0c\u4f46\u6279\u653e\u884c\u8bb0\u5f55\u7cfb\u7edf\u5e76\u4e0d\u662f\u7535\u5b50\u90ae\u4ef6\uff0c\u5219\u7535\u5b50\u90ae\u4ef6\u5e76\u4e0d\u662f\u4e00\u4efdGMP\u8bb0\u5f55\u3002\u7c7b\u4f3c\u5730\uff0c\u98ce\u9669\u8bc4\u4f30\u7684\u8349\u6848\u3001\u8c03\u67e5\u62a5\u544a\u8349\u6848\u7b49\u5728\u5176\u88ab\u5ba1\u6838\u5e76\u5b9a\u7a3f\u4e4b\u524d\u5747\u4e0d\u662fCGMP\u8bb0\u5f55\u3002\u5982\u679c\u516c\u53f8\u4f7f\u5c06\u7535\u5b50\u90ae\u4ef6\u7528\u4f5cGMP\u76ee\u7684\uff0c\u5219\u5efa\u8bae\u5236\u8ba2\u4e00\u4e2a\u53d7\u63a7\u7a0b\u5e8f\uff0c\u7531\u4e00\u4efdSOP\u6765\u7ba1\u7406\u3002<\/span><\/p>\n


<\/span><\/p>\n

Question 3: Personal Diaries <\/span>
\u95ee\u9898<\/span>3\uff1a\u4e2a\u4eba\u65e5\u8bb0<\/span><\/span><\/span><\/p>\n

Context: \u80cc\u666f<\/span><\/p>\n

It is commonfor employees to use personal diaries or paper to record notes for themselvesfor non-GMP purposes e.g. to-do list, training notes, personnel information.These notes are not considered to be GMP records by industry in general.Turning these notes into GMP records may in fact deter individuals from writingdown information that is useful for effective time management or reinforcingone\u2019s own learning.<\/span><\/p>\n

\u5458\u5de5\u7ecf\u5e38\u4f1a\u4f7f\u7528\u4e2a\u4eba\u65e5\u8bb0 \u6216\u7eb8\u5f20\u81ea\u5df1\u8bb0\u5f55\u4e00\u4e9b\u975eGMP\u7684\u4e8b\u60c5\uff0c\u5982\u4efb\u52a1\u6e05\u5355\u3001\u57f9\u8bad\u7b14\u8bb0 \u548c\u4e2a\u4eba\u4fe1\u606f\u3002\u4e00\u822c\u6765\u8bf4\u4f01\u4e1a\u4e0d\u4f1a\u8ba4\u4e3a\u8fd9\u4e9b\u7b14\u8bb0\u662fGMP\u8bb0\u5f55\u3002\u5c06\u8fd9\u4e9b\u7b14\u8bb0\u8f6c\u4e3aGMP\u8bb0\u5f55\u53ef\u80fd\u5b9e\u9645\u4e0a\u4f1a\u8ba9\u5458\u5de5\u4e0d\u6562\u628a\u4e00\u4e9b\u8fdb\u884c\u6709\u6548\u65f6\u95f4\u7ba1\u7406\u6216\u5f3a\u5316\u4e2a\u4eba\u5b66\u4e60\u7684\u6709\u7528\u4fe1\u606f\u5199\u4e0b\u6765\u3002<\/span><\/p>\n

Issue: What types ofentries\/information can be recorded in a personal diary without it being consideredGMP record?<\/span><\/p>\n


<\/span><\/p>\n

\u95ee\u9898\uff1a\u4ec0\u4e48\u7c7b\u578b\u7684\u8f93\u5165\/\u4fe1\u606f\u53ef\u4ee5\u8bb0\u5f55\u5728\u4e2a\u4eba\u65e5\u8bb0\u4e2d\u800c\u4e0d\u4f1a\u88ab\u8ba4\u4e3a\u662fGMP\u8bb0\u5f55\u5462\uff1f<\/span><\/p>\n

Clarification:If notes and diaries are used as personal and informal means of recording and arenot the system of record for execution or documentation of GMP activities, thenthey are not considered to be GMP records. These informal recordings inpersonal notebooks might include to-do lists, training notes, coaching ideas,personnel information, etc.). Firms may want to consider controlling and spotchecking personal notebooks to ensure that they are being used only for non-GMPinformation. Firms may also want to train employees on what is and is notproper for recording in personal notebooks.<\/span><\/p>\n

\u6f84\u6e05\uff1a\u5982\u679c\u7b14\u8bb0\u548c\u65e5\u8bb0\u7528\u4f5c\u4e2a\u4eba\u8bb0\u5f55\u53c2\u8003\u4fe1\u606f\u7684\u65b9\u6cd5\uff0c\u5e76\u4e0d\u662fGMP\u6d3b\u52a8\u6267\u884c\u6216\u6587\u4ef6\u5316\u7684\u8bb0\u5f55\u7cfb\u7edf\uff0c\u5219\u5e76\u4e0d\u4f1a\u8ba4\u4e3a\u5b83\u4eec\u662fGMP\u8bb0\u5f55\u3002\u8fd9\u4e9b\u5199\u5728\u4e2a\u4eba\u7b14\u8bb0\u672c\u4e0a\u7684\u975e\u6b63\u5f0f\u8bb0\u5f55\u53ef\u80fd\u5305\u62ec\u4efb\u52a1\u6e05\u5355\u3001\u57f9\u8bad\u7b14\u8bb0\u3001\u6559\u5bfc\u60f3\u6cd5\u4ee5\u53ca\u4e2a\u4eba\u4fe1\u606f\u7b49\u3002\u516c\u53f8\u53ef\u80fd\u60f3\u8fdb\u884c\u63a7\u5236\uff0c\u5e76\u62bd\u67e5\u4e2a\u4eba\u7b14\u8bb0 \u4ee5\u786e\u4fdd\u5458\u5de5\u53ea\u4f1a\u5c06\u5176\u7528\u4e8e\u975eGMP\u4fe1\u606f\u8bb0\u5f55\u3002\u516c\u53f8\u4ea6\u53ef\u80fd\u60f3\u8981\u57f9\u8bad\u5458\u5de5\uff0c\u544a\u77e5\u5176\u5728\u4e2a\u4eba\u7b14\u8bb0\u4e2d\u8bb0\u5f55\u4ec0\u4e48\u662f\u6070\u5f53\u7684\uff0c\u4ee5\u53ca\u8bb0\u5f55\u4ec0\u4e48\u662f\u4e0d\u6070\u5f53\u7684\u3002<\/span><\/p>\n

Question 4: Drafts of GMP documents <\/span>

<\/span><\/span><\/p>\n

\u95ee<\/span>4\uff1a<\/span>GMP\u6587\u4ef6\u7684\u8349\u7a3f<\/span><\/span><\/p>\n

Context: \u80cc\u666f<\/span><\/p>\n

Firms generatemany drafts of CGMP documents. It would be onerous and confusing to requirethat all of those documents be retained.<\/span><\/p>\n

\u516c\u53f8\u4f1a\u4ea7\u751f\u5f88\u591aCGMP\u6587\u4ef6\u7684\u8349\u6848\u3002\u5982\u679c\u8981\u6c42\u4fdd\u7559\u6240\u6709\u8fd9\u4e9b\u6587\u4ef6\uff0c\u53ef\u80fd\u4f1a\u5f88\u9ebb\u70e6\u5e76\u9020\u6210\u6df7\u6dc6\u3002<\/span><\/p>\n

Issue: Are firms required to retaindrafts of CGMP documents, such as reports of risk assessments, investigations,and validation?<\/span><\/p>\n

\u95ee\uff1a\u516c\u53f8\u9700\u8981\u4fdd\u5b58CGMP\u6587\u4ef6\u7684\u8349\u6848\u5417\uff1f\u5982\u98ce\u9669\u8bc4\u4f30\u62a5\u544a\u3001\u8c03\u67e5\u62a5\u544a\u548c\u9a8c\u8bc1\u62a5\u544a\u8349\u6848<\/span><\/p>\n

Clarification:Once a final GMP document of record is created, drafts and documents used in thecreation of the document of record no longer need to be retained. This includesdocuments and drafts used or created in the course of conducting aninvestigation. The final document is the document of record. GMP Change Controlprocesses come into effect once a GMP document is formally approved. As a partof maintaining control over GMP documents, it is advisable to make sure thatdrafts can be readily distinguished from final documents (e.g., they arestamped as \u201cdraft\u201d).<\/span><\/p>\n

\u6f84\u6e05\uff1a\u4e00\u65e6GMP\u6587\u4ef6\u6700\u7ec8\u6210\u7a3f\uff0c\u5c31\u4e0d\u9700\u8981\u4fdd\u7559\u7528\u4e8e\u8bb0\u5f55\u6587\u4ef6\u521b\u5efa\u7684\u6587\u4ef6\u548c\u8349\u6848\u4e86\u3002\u5176\u4e2d\u5305\u62ec\u6709\u5728\u6267\u884c\u8c03\u67e5\u8fc7\u7a0b\u4e2d\u4f7f\u7528\u6216\u521b\u5efa\u7684\u6587\u4ef6\u548c\u8349\u6848\u3002\u6700\u7ec8\u6587\u4ef6\u662f\u8bb0\u5f55\u6587\u4ef6\u3002\u4e00\u65e6\u6b63\u5f0f\u6279\u51c6\u4e86\u4e00\u4efdGMP\u6587\u4ef6\uff0c\u5219GMP\u53d8\u66f4\u63a7\u5236\u6d41\u7a0b\u751f\u6548\u3002\u4f5c\u4e3a\u4fdd\u6301GMP\u6587\u4ef6\u63a7\u5236\u7684\u4e00\u90e8\u5206\uff0c\u5efa\u8bae\u786e\u4fdd\u8349\u6848\u53ef\u4ee5\u660e\u663e\u533a\u522b\u4e8e\u6700\u7ec8\u6587\u4ef6\uff08\u4f8b\u5982\uff0c\u76d6\u6709\u201c\u8349\u6848\u201d\u5370\u7ae0\uff09\u3002<\/span><\/p>\n


<\/span><\/p>\n

Question 5: Emails as GMP records <\/span>
\u95ee\u9898<\/span>5\uff1a\u7535\u5b50\u90ae\u4ef6\u4f5c\u4e3a<\/span>GMP\u8bb0\u5f55<\/span><\/span><\/span><\/p>\n

Context:  \u80cc\u666f<\/span><\/p>\n

Firms usee-mail for a variety of GMP and non-GMP purposes. It is unclear to many firmswhich uses constitute GMP uses and whether a firm\u2019s entire e-mail systembecomes a GMP system due to its use.<\/span><\/p>\n

\u516c\u53f8\u4f7f\u7528\u7535\u5b50\u90ae\u4ef6\u6709\u4e0d\u540c\u7684GMP\u548c\u975eGMP\u76ee\u7684\u3002\u8bb8\u591a\u516c\u53f8\u4e0d\u592a\u6e05\u695a\u54ea\u79cd\u4f7f\u7528\u65b9\u6cd5\u7b97\u662fGMP\u7528\u9014\uff0c\u516c\u53f8\u7684\u6574\u4e2a\u7535\u5b50\u90ae\u4ef6\u7cfb\u7edf\u662f\u5426\u8981\u56e0\u4e3a\u6b64\u7c7b\u7528\u9014\u800c\u6210\u4e3a\u4e00\u4e2aGMP\u7cfb\u7edf\u3002<\/span><\/p>\n

Issue: Are e-mails considered to beGMP records?<\/span><\/p>\n

\u95ee\uff1a\u7535\u5b50\u90ae\u4ef6\u4f1a\u88ab\u8ba4\u4e3a\u662fGMP\u8bb0\u5f55\u5417\uff1f<\/span><\/p>\n

Clarification:Whether e-mails are GMP records depends on whether they are being used to communicateGMP actions or content or capture GMP decision-making.<\/span><\/p>\n

\u6f84\u6e05\uff1a\u7535\u5b50\u90ae\u4ef6\u662f\u5426GMP\u8bb0\u5f55\u53d6\u51b3\u4e8e\u4ed6\u4eec\u662f\u5426\u88ab\u7528\u4e8e\u4ea4\u6d41GMP\u884c\u52a8\u6216\u5185\u5bb9\u6216\u83b7\u53d6GMP\u51b3\u7b56\u3002<\/span><\/p>\n

For example,if e-mail is used as the system of record for batch release, then those e-mailsare GMP records, and local procedures should be clear on what is the system ofrecord. If e-mail is used to communicate that a batch has been dispositioned,but that decision is formally captured elsewhere in accordance with the firm\u2019sSOPs, then the e-mail is not a GMP record. Similarly, if e-mail is used as the officialsystem for escalation of quality issues per a firm\u2019s SOPs, then those e-mailsare GMP records. If e-mail is used for informational purposes to note thatthere has been an escalation, and there is a separate system of record forescalations, then the e-mail is not a GMP record. The use of e-mail in GMPprocess(es) should be well-described in the relevant SOP(s).<\/span><\/p>\n

\u4f8b\u5982\uff0c\u5982\u679c\u7535\u5b50\u90ae\u4ef6\u88ab\u7528\u4f5c\u6279\u653e\u884c\u8bb0\u5f55\u7cfb\u7edf\uff0c\u5219\u8fd9\u4e9b\u7535\u5b50\u90ae\u4ef6\u5c31\u662fGMP\u8bb0\u5f55\uff0c\u5e76\u4e14\u5185\u90e8\u9700\u8981\u6709\u7a0b\u5e8f\u5199\u6e05\u695a\u8bb0\u5f55\u7cfb\u7edf\u662f\u4ec0\u4e48\u3002\u5982\u679c\u7535\u5b50\u90ae\u4ef6\u88ab\u7528\u4e8e\u4ea4\u6d41\u4e00\u4e2a\u6279\u6b21\u662f\u5426\u5df2\u7ecf\u88ab\u5904\u7f6e\uff0c\u4f46\u8be5\u51b3\u7b56\u662f\u4f9d\u636e\u516c\u53f8\u7684SOP\u4ece\u5176\u5b83\u5730\u65b9\u83b7\u53d6\u7684\uff0c\u5219\u8be5\u7535\u5b50\u90ae\u4ef6\u5c31\u4e0d\u662fGMP\u8bb0\u5f55\u3002\u7c7b\u4f3c\u5730\uff0c\u5982\u679c\u7535\u5b50\u90ae\u4ef6\u4f9d\u636e\u516c\u53f8SOP\u88ab\u7528\u4f5c\u8d28\u91cf\u95ee\u9898\u5347\u7ea7\u5904\u7406\u7684\u6b63\u5f0f\u7cfb\u7edf\uff0c\u5219\u8fd9\u4e9b\u90ae\u4ef6\u5c31\u662fGMP\u8bb0\u5f55\u3002\u5982\u679c\u7535\u5b50\u90ae\u4ef6\u88ab\u7528\u4f5c\u901a\u77e5\u63d0\u9192\u8be5\u5347\u7ea7\u5904\u7406\u4e8b\u4ef6\uff0c\u5e76\u4e14\u8fd8\u6709\u53e6\u4e00\u4e2a\u5355\u72ec\u7684\u7cfb\u7edf\u7528\u4f5c\u5347\u7ea7\u8bb0\u5f55\uff0c\u5219\u8be5\u7535\u5b50\u90ae\u4ef6\u5c31\u4e0d\u662fGMP\u8bb0\u5f55\u3002\u5728GMP\u6d41\u7a0b\u4e2d\u4f7f\u7528\u7535\u5b50\u90ae\u4ef6\u5e94\u5728\u76f8\u5173SOP\u4e2d\u6e05\u695a\u63cf\u8ff0\u3002<\/span><\/p>\n

To create aGMP record that is separate from the e-mail system, and to avoid an e-mailsystem being used as a GMP system of record, a firm may wish to considerprinting, signing\/initialing, and dating all of the relevant e-mails thatconstitute a GMP record. All of this should be done in accordance with a writtenSOP.<\/span><\/p>\n

\u4e3a\u4e86\u521b\u5efa\u4e00\u4efd\u72ec\u7acb\u4e8e\u7535\u5b50\u90ae\u4ef6\u7cfb\u7edf\u4ee5\u5916\u7684GMP\u8bb0\u5f55\uff0c\u4e5f\u4e3a\u4e86\u907f\u514d\u4f7f\u7528\u7535\u5b50\u90ae\u4ef6\u7cfb\u7edf\u4f5c\u4e3aGMP\u8bb0\u5f55\u7cfb\u7edf\uff0c\u516c\u53f8\u53ef\u80fd\u4f1a\u5e0c\u671b\u8003\u8651\u5c06\u6240\u6709\u542b\u6709GMP\u8bb0\u5f55\u7684\u76f8\u5173\u90ae\u4ef6\u6253\u5370\u51fa\u6765\u5e76\u7b7e\u540d\u52a0\u65e5\u671f\u3002\u6240\u6709\u8fd9\u4e9b\u64cd\u4f5c\u5747\u5e94\u4f9d\u636e\u4e66\u9762SOP\u5b8c\u6210\u3002<\/span><\/p>\n

Question 6: Business records that are not GMP records <\/span>

<\/span><\/span><\/p>\n

\u95ee\u9898<\/span>6\uff1a\u4e0d\u662f<\/span>GMP\u8bb0\u5f55\u7684\u5546\u52a1\u8bb0\u5f55<\/span><\/span><\/p>\n

Context: \u80cc\u666f<\/span><\/p>\n

Recent inspectionshave delved into business records that are not GMP records, such as footagefrom security cameras, drafts of GMP documents such as investigations,uncontrolled document copies, and security key card access systems. FDA maychoose to inspect these items and may even use them as a means of finding GMPviolations. However, the fact that records may be inspected should not meanthat these items are GMP records. Otherwise, it would create an enormous burdenon the Quality Unit to review and control new kinds of records.<\/span><\/p>\n

\u6700\u8fd1\u7684\u5b98\u65b9\u68c0\u67e5\u5f00\u59cb\u67e5\u9605\u975eGMP\u8bb0\u5f55\u7684\u5546\u52a1\u8bb0\u5f55\uff0c\u5982\u5b89\u4fdd\u5f55\u50cf\u3001GMP\u6587\u4ef6\u5982\u8c03\u67e5\u6587\u4ef6\u7684\u8349\u6848\u3001\u975e\u53d7\u63a7\u6587\u4ef6\u526f\u672c\uff0c\u4ee5\u53ca\u5b89\u5168\u94a5\u5319\u5361\u51fa\u5165\u7cfb\u7edf\u3002FDA\u53ef\u80fd\u4f1a\u9009\u62e9\u68c0\u67e5\u8fd9\u4e9b\u9879\u76ee\uff0c\u751a\u81f3\u53ef\u80fd\u5229\u7528\u5176\u4f5c\u4e3a\u53d1\u73b0GMP\u8fdd\u89c4\u884c\u4e3a\u7684\u65b9\u6cd5\u3002\u4f46\u662f\uff0c\u8fd9\u4e9b\u8bb0\u5f55\u53ef\u80fd\u4f1a\u88ab\u68c0\u67e5\u7684\u4e8b\u5b9e\u5e76\u4e0d\u8868\u793a\u8fd9\u4e9b\u4e8b\u7269\u90fd\u662fGMP\u8bb0\u5f55\u3002\u5426\u5219\uff0c\u5c06\u4f1a\u5bf9\u8d28\u91cf\u90e8\u95e8\u9020\u6210\u5de8\u5927\u7684\u8d1f\u62c5\uff0c\u65b9\u53ef\u5bf9\u65b0\u7c7b\u578b\u7684\u8bb0\u5f55\u8fdb\u884c\u5ba1\u6838\u548c\u63a7\u5236\u3002<\/span><\/p>\n

Issue: If non-GMP records, such asfootage from security cameras, drafts of GMP documents such as investigations,uncontrolled document copies, and security key card access systems are inspected,does that mean that they are considered to be GMP records?<\/span><\/p>\n

\u95ee\uff1a\u5982\u679c\u8981\u68c0\u67e5\u975eGMP\u8bb0\u5f55\uff0c\u5982\u5b89\u4fdd\u5f55\u50cf\u3001GMP\u6587\u4ef6\u5982\u8c03\u67e5\u7684\u8349\u6848\u3001\u975e\u53d7\u63a7\u6587\u4ef6\u526f\u672c\uff0c\u4ee5\u53ca\u5b89\u5168\u94a5\u5319\u5361\u51fa\u5165\u7cfb\u7edf\uff0c\u662f\u5426\u8868\u793a\u8fd9\u4e9b\u90fd\u88ab\u8ba4\u4e3a\u662fGMP\u8bb0\u5f55\uff1f<\/span><\/p>\n

Clarification:No. When generated to satisfy a CGMP requirement, all data become a CGMP record.But the fact that a non-GMP record may be subject to inspection or may be thesource of an inspectional observation pertaining to a GMP issue does not turn itinto a GMP record. However, if a system is intended to provide documentedevidence of a GMP function or GMP result then it is a GMP system. For example,if a key card entry system is used beyond employee exit and entry and is usedas a log to monitor time spent in an aseptic core for purposes of media fillcompliance, then it is being used for GMP purposes and should be clearlydefined as such by local procedure. However, if such a system is evaluated onan occasional retrospective basis as part of a GMP investigation to ensure thatan employee did not over-stay in the aseptic core, then that does not mean itshould be considered a GMP system. Of course, any documentation from thatsystem that is part of an investigation should be kept (in paper or electronicform) as a part of the investigation.<\/span><\/p>\n

\u6f84\u6e05\uff1a\u4e0d\u662f\u3002\u6240\u6709\u4e3a\u4e86\u6ee1\u8db3CGMP\u8981\u6c42\u800c\u751f\u6210\u7684\u6570\u636e\u662fCGMP\u8bb0\u5f55\u3002\u4f46\u975eGMP\u8bb0\u5f55\u53ef\u80fd\u4f1a\u88ab\u68c0\u67e5\uff0c\u6216\u53ef\u80fd\u6210\u4e3a\u4e0eGMP\u95ee\u9898\u6709\u5173\u7684\u68c0\u67e5\u7f3a\u9677\u7684\u6765\u6e90\u7684\u4e8b\u5b9e\uff0c\u5e76\u4e0d\u4f1a\u5c06\u53d7\u68c0\u67e5\u7684\u975eGMP\u8bb0\u5f55\u8f6c\u5316\u4e3aGMP\u8bb0\u5f55\u3002\u4f46\u662f\uff0c\u5982\u679c\u4e00\u4e2a\u7cfb\u7edf\u7684\u76ee\u7684\u662f\u4e3a\u4e00\u9879GMP\u529f\u80fd\u6216GMP\u7ed3\u679c\u63d0\u4f9b\u6587\u4ef6\u5316\u8bc1\u636e\uff0c\u5219\u5176\u5c31\u662fGMP\u7cfb\u7edf\u3002\u4f8b\u5982\uff0c\u5982\u679c\u4e00\u4e2a\u94a5\u5319\u5361\u95e8\u7981\u7cfb\u7edf\u88ab\u7528\u4e8e\u5458\u5de5\u8fdb\u51fa\u4ee5\u5916\u7684\u63a7\u5236\uff0c\u5e76\u4e14\u88ab\u7528\u4f5c\u57f9\u517b\u57fa\u704c\u88c5\u5408\u89c4\u7684\u65e0\u83cc\u4e2d\u5fc3\u91cc\u505c\u7559\u65f6\u95f4\u76d1\u6d4b\u7684\u65e5\u5fd7\uff0c\u5219\u5176\u5c31\u662f\u88ab\u7528\u4e8e\u4e86GMP\u7528\u9014\uff0c\u5e94\u8be5\u5728\u5185\u90e8\u7a0b\u5e8f\u91cc\u6e05\u695a\u5b9a\u4e49\u3002\u4f46\u662f\uff0c\u5982\u679c\u6b64\u7cfb\u7edf\u53ea\u662f\u5076\u5c14\u56de\u987e\u6027\u5730\u4f5c\u4e3aGMP\u8c03\u67e5\u4e00\u90e8\u5206\u8fdb\u884c\u8bc4\u4f30\uff0c\u4ee5\u786e\u4fdd\u5458\u5de5\u5e76\u672a\u5728\u65e0\u83cc\u4e2d\u5fc3\u8d85\u65f6\u505c\u7559\uff0c\u5219\u8be5\u7cfb\u7edf\u5e76\u4e0d\u4e00\u5b9a\u88ab\u8ba4\u4e3a\u662fGMP\u7cfb\u7edf\u3002\u5f53\u7136\uff0c\u8be5\u7cfb\u7edf\u4e2d\u4f5c\u4e3a\u8c03\u67e5\u90e8\u5206\u7684\u6587\u4ef6\u8bb0\u5f55\u5e94\u8be5\u4fdd\u7559\u4f5c\u4e3a\u8c03\u67e5\u7684\u8d44\u6599\u3002<\/span><\/p>\n


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\u95ee\u9898\u672a\u5b8c\u5f85\u7eed\uff01\u53ef\u4ee5\u70b9\u51fb\u201c\u9605\u8bfb\u539f\u6587\u201d\uff0c\u8fdb\u5165\u84b2\u516c\u82f1\u8bba\u575b\u4e0b\u8f7d\uff08\u9700\u652f\u4ed82\u91d1\u5e01\uff09\uff0c\u4e5f\u53ef\u4ee5\u5173\u6ce8\u672c\u516c\u4f17\u53f7\uff0c\u4e0b\u4e00\u7bc7\u63a8\u9001\u540e\u534a\u90e8\u5206\u3002<\/span><\/p>\n


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\u63a8\u8350\u57f9\u8bad\uff1a<\/span><\/strong><\/p>\n


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\u514d\u8d39\uff1a\u84b2\u516c\u82f12018\uff08\u5de5\u7a0b\u6280\u672f\uff09\u5168\u56fd\u4ea4\u6d41\u4f1a\uff08\u5609\u5174\u7ad9\uff09<\/a>
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\"PDA\u601d\u8003\uff1aGMP\u8fce\u68c0\uff0c\u975eGMP\u5185\u5bb9\u4f60\u4e5f\u51c6\u5907\u597d\u4e86\u4e48\uff1f\"<\/p>\n

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\u59cb\u53d1\u4e8e\u5fae\u4fe1\u516c\u4f17\u53f7\uff1a \u84b2\u516c\u82f1 <\/p>\n<\/blockquote>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

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