Difference between revisions of "Template:LIMSpec for Cannabis Testing/Standard and reagent 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;"| | ||
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! 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 | ||
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▪ [https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252 (c)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252 (c)]<br /> | ||
▪ [http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-17]<br /> | ▪ [http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-17]<br /> | ||
▪ [https://www.astm.org/ | ▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-7-1]<br /> | ||
▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.2.4–5]<br /> | ▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.2.4–5]<br /> | ||
▪ [http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 4.4] | ▪ [http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 4.4] | ||
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▪ [https://www.law.cornell.edu/cfr/text/21/312.58 21 CFR Part 312.58 (b)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/312.58 21 CFR Part 312.58 (b)]<br /> | ||
▪ [https://www.law.cornell.edu/cfr/text/42/73.3 42 CFR Part 73.3–4 (c)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/42/73.3 42 CFR Part 73.3–4 (c)]<br /> | ||
▪ [https://www.astm.org/ | ▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-7-2]<br /> | ||
▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.1.12]<br /> | ▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.1.12]<br /> | ||
▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.2.4]<br /> | ▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.2.4]<br /> | ||
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| style="background-color:white; vertical-align: text-top;" |'''14.2''' The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and/or chemical stability.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''14.2''' The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and/or chemical stability.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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| style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/ | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-7-3]<br />▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.2.4] | ||
| style="background-color:white; vertical-align: text-top;" |'''14.3''' The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''14.3''' The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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| style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/ | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-7-4]<br />▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.2.4] | ||
| style="background-color:white; vertical-align: text-top;" |'''14.4''' The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''14.4''' The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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| style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/ | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-7-5]<br />▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.2.4] | ||
| style="background-color:white; vertical-align: text-top;" |'''14.5''' The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''14.5''' The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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Latest revision as of 15:11, 23 June 2023
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