National Quality Infrastructure: The Metrology PerspectiveAlan Steele, PhD, FRSCChief MetrologistDirector General, NRC MetrologyApril 4, 2019
Introduction and Overview
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• Some background on NRC Metrology
• An introduction to National Quality Infrastructure
• Cannabis: emerging market NQI Case Study
NRC: By the numbers
• Over 4,500 employees and visitors• 4 scientific divisions with 14 research centres• Industrial Research Assistance Program
NRC Metrology: Canada's National Metrology Institute
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We help when high-precision measurement is critical to success• Accurate, traceable measurements• Innovative technology and high-performance
laboratories• Advisory and calibration services for high
precision measurements
Organizational Structure
NRC – Metrology
Biotoxin Metrology
Black Carbon Metrology
Dimensional Metrology
Electrical Power Measurement
Electrical Standards
Inorganic Chemical Metrology
Mass & Related Quanities
Medical & Industrial Dosimetry
Nanoscale Measurement
Organic Chemical Metrology
Photometry & Spectrophotometry
Radiation, Environment & Security Frequency & Time
Directors of Research and Development
Operations
Chief Metrologist
Thermometry and Radiometry Quality System
Measurement System Engagement
Assessment Services
Research & Development
Nano
Metrology TeamsMetrology Sectors NRC Initiatives
PDF Program
Common Services
Challenge Program
Collaboration Centres
Supper Cluster Support
Small Teams New Beginnings
Disseminating National Standards: Calibration and Technical Services
NRC helps clients solve immediate problems
• Calibrations
• Certified reference materials
• GD-MS analysis
• Laboratory assessment services
National Quality Infrastructure
“The system comprising the organizations(public and private) together with the policies, relevant legal and regulatory framework, and practices needed to support and enhance the quality, safety and environmental soundness of goods, services and processes.
UNIDO Definition (2017)
National Quality Infrastructure
The quality infrastructure is required for the effective operation of domestic markets, and its international recognition is important to enable access to foreign markets. It is a critical element in promoting and sustaining economic development, as well as environmental and social wellbeing.
UNIDO Definition (2017)
National Quality Infrastructure
NQI relies on: metrology, standardization, accreditation, conformity assessment, and market surveillance.”
UNIDO Definition (2017)
Disseminating National Standards: Accreditation
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In Canada, the accreditation of calibration laboratories is the shared responsibility of the Standards Council of Canada - Laboratory Accreditation Program, and the National Research Council of Canada - Calibration Laboratory Assessment Service
Certified Reference Materials (CRM)
For decades, NRC has been developing and producing high-quality CRMs that laboratories around the world trust to provide: precise measurement values, traceable references, standards, valid process methodologies, and samples with correct concentrations. These materials relate to regulatory safeguards for food safety, and environmental health.
NRC collaborates with industry, government departments, and other countries’ national metrology institutes (NMIs) for the development of materials.
Currently 4 teams within MSS developing CRMs – Biotoxin Metrology, Inorganic Chemical Metrology, Organic Chemical Metrology, and Nanoscale Measurement.
NRC sells approximately 10,000 certificates per year, to over 300 clients, in 55 countries. Our clients include government departments, inspection agencies, ISO-certified laboratories, and academic and private research teams.
As of today NRC metrology has 73 materials available to clients, with close to an additional 20 in development.
ResearchAnalytical chemistry, toxin identification,
algal culture
Certified Reference Materials>35 CRMs distributed in Canada and
around the world
EngagementIndustry clients, OGDs, CCQM, etc.
15 staff located in Halifax, NS
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Biotoxin CRM Distribution
Biotoxin Metrology
Cannabis: An Emerging Marketplace
Medicinal cannabis has been available in Canada since 1999 under: Access to Cannabis for Medical Purposes Regulations (ACMPR)
Adult recreational cannabis was legalized in Canada on October 17th, 2018
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• Market is highly regulated, similar to previous medicinal market, or even more stringent
• Federal regulations for testing include:• Major cannabinoids• Pesticides (current list of 95)• Heaving metals• Mycotoxins• Residual solvents• Bacteria
Cannabis testing frequently in the media
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• “….The samples were sent to an accredited lab to test for THC and CBD levels.
• Testing showed that many of the labels were not accurate; only two of the labelled samples fell within one percentage point of what was listed. And many of the samples contained more THC than listed.
• For example, one sample said it contained 13 per cent THC, but testing showed it contained 18 per cent. Another sample contained only half of what was promised.
• None of the samples contained a detectable level of CBD.”
Pesticides have caused several recent cannabis recalls
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myclobutanil
• Can be used relatively safely on most crops that are eaten
• However, hydrogen cyanide is released upon smoking
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“The Cannabinoid Content of Legal Cannabis in Washington State Varies Systematically Across Testing Facilities”
Nick Jikomes & Michael Zoorob(2018) 8:4519
NRC is addressing these challenges in cannabis testing though standards development
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• While NRC is leading the development of standards, NRC is not a regulator.• NRC provides guidance and research to Health Canada for regulatory decisions.
Documentary standards(Methods)
• Standard methods are being developed with organizations such as ASTM, and US Pharmacopeia
Certified reference materials (CRMs)
Laboratory standards under development at ASTM (ASTM D37.03)
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• WK60319 Laboratory Test Method Validation and Method Development
• WK60479 Quality Assurance and Quality Control for Cannabis Analytical Methods and Laboratories
• WK63913 Analytical Laboratory Operations Supporting the Cannabis Industry
• WK64333 Multiresidue Analysis of Pesticides in Cannabis Leaves and Oils using Gas Chromatography-Mass Spectroscopy (GC-MS)
• WK64334 Multiresidue Analysis of Pesticides in Cannabis Leaves using Gas Chromatography-Tandem Mass Spectroscopy (GC-MS/MS)
• WK64335 Multiresidue Analysis of Pesticides in Cannabis Leaves, Flowers, and Oil using HPLC-tandem mass spectroscopy (HPLC-MS/MS)
• WK64336 The Sampling of Cannabis Products for Subsequent Laboratory Analyses of Harvest Lots of Usable Marijuana in Support of Regulatory and Quality Control Elements
• WK64646 The Sampling of Cannabis Products for Subsequent Laboratory Analyses of Marijuana Process lots including, extracts, concentrates, and products in Support of Laboratory Analyses for Regulatory and Quality Control Elements.
• WK65013 Determination of Cannabinoid Concentration in Cannabis Using High Performance Liquid Chromatography
• WK65014 Analyses of Terpenes in Cannabis using Gas Chromatography-tandem Mass Spectrometry (GC-MS/MS)
• WK65015 Analyses of Trace Elements in Cannabis by Inductively Coupled Plasma-Mass Spectrometry (ICP-MS)
• WK65018 Analysis of Class 2 Residual Solvents in Cannabis Oil
• WK65194 Stability Testing Standard Guide for Cannabis Products
• WK65402 Determination of Cannabinoids in thermally prepared food products (edibles) using Thermal desorption Gas chromatography/mass spectrometry (TD-GC/MS) or Gas chromatography flame ionization detector (GC/FID)
• WK66628 Assay for real-time stability of cannabis products for inhalation.
Certified Reference Material Development
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Pure materials or calibration solutions:• Primary standards• Calibration of instruments and assays• Required for certifying matrix CRMsMatrix materials (representative):• Validation of entire methods• QA & QC• Verification of correct application of standardized
methods
Metrology in Chemistry: ISO17034
• Matrix CRMs are large-scale projects requiring multiple steps for production and certification
Selection of material
Processing, homogenization
Bottling/packaging
Stability study
Characterization (ie quantitation)
Homogeneity study
Value assignment and uncertainty estimation
Homogeneity is Key … Measurands Matter
We are putting the metrology in place
What’s Still Missing? The NQI Overlay
• Social License• Business Confidence• Efficient Marketplace
• Comprehensive Regulatory Framework• Standard test methods for Evidence• Laboratory Accreditation and Surveillance
Thanks for listening!
• Alan [email protected]
• Ralph [email protected]
• Georgette [email protected]