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:175px;"| 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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| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
[https://www.law.cornell.edu/cfr/text/21/58.83 21 CFR Part 58.83]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/58.83 21 CFR Part 58.83]<br /> | ||
[https://www.law.cornell.edu/cfr/text/29/1910.1200 29 CFR Part 1910.1200 (g)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/29/1910.1200 29 CFR Part 1910.1200 (g)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (h)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (h)]<br /> | ||
[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/Standards/E1578.htm ASTM E1578-18 E-7-1]<br /> | ▪ [https://www.astm.org/Standards/E1578.htm 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] | ||
| style="background-color:white;" |'''14.1''' The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials. | | style="background-color:white; vertical-align: text-top;" |'''14.1''' The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.<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.law.cornell.edu/cfr/text/7/331.3 7 CFR Part 331.3]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/7/331.3 7 CFR Part 331.3]<br /> | ||
[https://www.law.cornell.edu/cfr/text/9/121.3 9 CFR Part 121.3]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/9/121.3 9 CFR Part 121.3]<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/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/Standards/E1578.htm ASTM E1578-18 E-7-2]<br /> | ▪ [https://www.astm.org/Standards/E1578.htm 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 /> | ||
[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 12.20] | ▪ [https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 12.20] | ||
| style="background-color:white;" |'''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. | | 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:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/Standards/E1578.htm 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;" |'''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. | | 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:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/Standards/E1578.htm 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;" |'''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. | | 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:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/Standards/E1578.htm 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;" |'''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. | | 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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Revision as of 00:48, 30 January 2021
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