Difference between revisions of "Template:LIMSpec for Cannabis Testing/Batch and lot management"
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! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"| | ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"| | ||
|- | |- | ||
! style="color:brown; background-color:#ffffee; width: | ! style="color:brown; background-color:#ffffee; width:250px;"| Regulation, Specification, or Guidance | ||
! style="color:brown; background-color:#ffffee; width:700px;"| Requirement | ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement | ||
|- | |- | ||
| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
[https://www.law.cornell.edu/cfr/text/21/58.105 21 CFR Part 58.105 (a)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/58.105 21 CFR Part 58.105 (a)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/211.80 21 CFR Part 211.80]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/211.80 21 CFR Part 211.80]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/225.102 21 CFR Part 225.102]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/225.102 21 CFR Part 225.102]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/226.102 21 CFR Part 226.102]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/226.102 21 CFR Part 226.102]<br /> | ||
[https://www.astm.org/ | ▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-4-1]<br /> | ||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.3]<br /> | ▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.3]<br /> | ||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.10.1]<br /> | ▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.10.1]<br /> | ||
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 6.2] | ▪ [http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 6.2] | ||
| style="background-color:white;" |'''11.1''' The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria. | | style="background-color:white; vertical-align: text-top;" |'''11.1''' The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
|- | |- | ||
| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
[https://www.law.cornell.edu/cfr/text/21/211.80 21 CFR Part 211.80]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/211.80 21 CFR Part 211.80]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/225.102 21 CFR Part 225.102]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/225.102 21 CFR Part 225.102]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/226.102 21 CFR Part 226.102]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/226.102 21 CFR Part 226.102]<br /> | ||
[https://www.astm.org/ | ▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-4-2]<br /> | ||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.10.1] | ▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.10.1] | ||
| style="background-color:white;" |'''11.2''' The system shall maintain the links between component parts of a batch and track the batch throughout the system. | | style="background-color:white; vertical-align: text-top;" |'''11.2''' The system shall maintain the links between component parts of a batch and track the batch throughout the system.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
|- | |- | ||
| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
[https://www.law.cornell.edu/cfr/text/21/211.80 21 CFR Part 211.80]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/211.80 21 CFR Part 211.80]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/225.102 21 CFR Part 225.102]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/225.102 21 CFR Part 225.102]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/226.102 21 CFR Part 226.102]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/226.102 21 CFR Part 226.102]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/820.65 21 CFR Part 820.65]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/820.65 21 CFR Part 820.65]<br /> | ||
[https://www.astm.org/ | ▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-4-3] | ||
| style="background-color:white;" |'''11.3''' The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample. | | style="background-color:white;" |'''11.3''' The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-4-4] | ||
| style="background-color:white;" |'''11.4''' The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results. | | style="background-color:white; vertical-align: text-top;" |'''11.4''' The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-15] | ||
| style="background-color:white;" |'''11.5''' The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so. | | style="background-color:white; vertical-align: text-top;" |'''11.5''' The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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Latest revision as of 15:10, 23 June 2023
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