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| | style = width: 960px; | | | style = width: 960px; |
| | text = This is sublevel15 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see [[User_talk:Shawndouglas|my discussion page]] instead.<p></p> | | | text = This is sublevel16 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see [[User_talk:Shawndouglas|my discussion page]] instead.<p></p> |
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| ==Sandbox begins below== | | ==Sandbox begins below== |
| | | <div class="nonumtoc">__TOC__</div> |
| ==16. Production Management==
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| {|
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| | STYLE="vertical-align:top;"|
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| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
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| ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
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| ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
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| ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
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| | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/211.103 21 CFR Part 211.103]<br />[https://www.law.cornell.edu/cfr/text/21/226.40 21 CFR Part 226.40 (d)]<br />[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.4 and 16.20]
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| | style="background-color:white;" |'''16.1''' The system should be able to calculate and record theoretical and actual percentage of yield at various phases of processing, manufacturing, and packaging.
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| | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/211.103 21 CFR Part 211.103]
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| | style="background-color:white;" |'''16.2''' The system should provide a means for verification and approval of yield calculations before release for reporting.
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| | style="padding:5px; width:500px;" |
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| [https://www.law.cornell.edu/cfr/text/21/820.20 21 CFR Part 820.20]<br />
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| [https://www.law.cornell.edu/cfr/text/21/820.40 21 CFR Part 820.40]<br />
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| [https://www.law.cornell.edu/cfr/text/21/820.186 21 CFR Part 820.186]<br />
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| [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2003_94/dir_2003_94_en.pdf E.U. Commission Directive 2003/94/EC Article 11]<br />
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| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 1.0]
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| | style="background-color:white;" |'''16.3''' The system shall be able to maintain a production facility's quality system in a specific quality system record, in accordance with regulations and guidance such as 21 CFR Part 820.20 and 820.40 (U.S.), E.U. Commission Directive 2003/94/EC Article 11 (E.U.), and WHO Technical Report Series, #986, Annex 2, 1.0 (global).
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| | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/820.30 21 CFR Part 820.30]<br />[https://www.law.cornell.edu/cfr/text/21/820.120 21 CFR Part 820.120 (e)]
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| | style="background-color:white;" |'''16.4''' The system shall be able to create a design control document capable of recording the details surrounding device development, including control number, physical and performance requirements, final output, review, verification, approval, transfer, changes, and complete design history.
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| | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/820.181 21 CFR Part 820.181]<br />[https://www.law.cornell.edu/cfr/text/21/820.184 21 CFR Part 820.184]
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| | style="background-color:white;" |'''16.5''' The system shall be able to create a device master and device history record capable of recording all information described in 21 CFR Part 820.181 and 820.184.
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| | style="padding:5px; width:500px;" |
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| [https://www.law.cornell.edu/cfr/text/21/211.105 21 CFR Part 211.105 (b)]<br />
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| [https://www.law.cornell.edu/cfr/text/21/211.130 21 CFR Part 211.130 (e)]<br />
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| [https://www.law.cornell.edu/cfr/text/21/211.134 21 CFR Part 211.134 (c)]<br />
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| [https://www.law.cornell.edu/cfr/text/21/211.188 21 CFR Part 211.188]<br />
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| [https://www.law.cornell.edu/cfr/text/21/211.20 21 CFR Part 211.20 (d)]<br />
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| [https://www.law.cornell.edu/cfr/text/21/211.50 21 CFR Part 211.50 (c)]<br />
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| [https://www.law.cornell.edu/cfr/text/21/225.102 21 CFR Part 225.102]<br />
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| [https://www.law.cornell.edu/cfr/text/21/225.202 21 CFR Part 225.202]<br />
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| [https://www.law.cornell.edu/cfr/text/21/226.80 21 CFR Part 226.80]<br />
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| [https://www.law.cornell.edu/cfr/text/21/226.102 21 CFR Part 226.102]<br />
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| [https://www.law.cornell.edu/cfr/text/21/820.60 21 CFR Part 820.60]<br />
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| [https://www.law.cornell.edu/cfr/text/21/820.70 21 CFR Part 820.70 (a)]<br />
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| [https://www.law.cornell.edu/cfr/text/21/820.80 21 CFR Part 820.80 (c)]<br />
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| [https://www.law.cornell.edu/cfr/text/21/820.120 21 CFR Part 820.120 (d)]<br />
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| [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2003_94/dir_2003_94_en.pdf E.U. Commission Directive 2003/94/EC Article 9.1]<br />
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| [https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 2 and 4]<br />
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| [https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 7]<br />
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| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (a) and (f–g)]<br />
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| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.25–30]
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| | style="background-color:white;" |'''16.6''' The system shall be able to create a batch production record capable of recording complete information regarding batch production and control details such as, but not limited to, a unique batch or production run number, formulation, specific labeling and packaging, production steps, in-process and laboratory control results, the unique identifier of any equipment used, persons performing and/or supervising operational steps, and the results of any pre-process or post-production inspections.
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| |}
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| |}
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