Difference between revisions of "Template:LIMSpec for Cannabis Testing/Sample, experiment, and study approval and verification"
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Shawndouglas (talk | contribs) (Updated for 2023.) |
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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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| 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 C-5-1]<br /> | |||
▪ [https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<br /> | |||
▪ [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.3.5]<br /> | |||
▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP 5.9–10]<br /> | |||
▪ [https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.12.1] | |||
| style="background-color:white; vertical-align: text-top;" |'''5.1''' The system shall accurately record all details of a sample's final disposition, including, when applicable, storage container type and ID, disposal method, disposal location, person responsible for disposition, etc.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''5.1''' The system shall accurately record all details of a sample's final disposition, including, when applicable, storage container type and ID, disposal method, disposal location, person responsible for disposition, etc.<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.aihaaccreditedlabs.org/policies AIHA-LAP Policies | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
▪ [https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2022 2A.7.7.2]<br /> | |||
▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-5-2]<br /> | |||
▪ [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.2.2]<br /> | |||
▪ [https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers EMA Guidance on Good Manufacturing Practice and Good Distribution Practice]<br /> | |||
▪ [https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5, 4.12] | |||
| style="background-color:white; vertical-align: text-top;" |'''5.2''' The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''5.2''' The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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Latest revision as of 00:16, 22 June 2023
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