National Quality Infrastructure: The Metrology Perspective Alan - - PowerPoint PPT Presentation

National Quality Infrastructure: The Metrology Perspective

Alan Steele, PhD, FRSC Chief Metrologist Director General, NRC Metrology April 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 Teams Metrology 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.

Research

Analytical chemistry, toxin identification, algal culture

Certified Reference Materials

>35 CRMs distributed in Canada and around the world

Engagement

Industry clients, OGDs, CCQM, etc.

15 staff located in Halifax, NS

• 1000

1000 2000 3000 4000 5000 6000 7000 8000 1990 1995 2000 2005 2010 2015

CRM units FY

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

• rganizations 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 CRMs

Matrix 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 Steele

alan.steele@nrc-cnrc.gc.ca

• Ralph Paroli

ralph.paroli@nrc-cnrc.gc.ca

• Georgette Macdonald

georgette.macdonald@nrc.ca