Cannabis 201. Cannabis Edibles and Beverage Manufacturing: Food Safety, and Quality Control. Sponsored by: Presented by:

Transcription

1 Cannabis 201 Cannabis Edibles and Beverage Manufacturing: Food Safety, and Quality Control Sponsored by: Presented by:

2 Welcome Tanya Tait, Member Services Manager at the BC Food Processors Association

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5 GETTING LICENSED PRODUCERS READY FOR COMPLIANCE (Part I) ANDREW SAMANN, SGS

6 Outline Introduction Acronyms Importance of Standards Acronyms Why does this matter to you? Current industry challenges ACMPR into the Cannabis Act and Beyond

7 Introduction Who We Are SGS Auditors and Consultants Gap assessments of companies both in the US and Canada including pharma, nutraceutical and cannabis companies Andrew Samann David Vaillencourt

8 Why Are We Involved? Inform Assess Educate Assist your company in becoming compliant

9 Acronyms Let s get these out of the way: Bodies WHO World Health Organization ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ISO International Organization on Standards ASTM International AHPA American Herbal Products Association

10 Acronyms Regulations/Guidance Documents SCND 1961 United Nations Single Convention on Narcotic Drugs ACMPR Access to Cannabis for Medical Purposes Regulations IHR Industrial Hemp Regulations CDSA Controlled Drugs and Substances Act FDA Food and Drug Administration Food and Drugs Act AHP American Herbal Pharmacopeia GxP Good Practices GPP Good Production Practices GDP Gross Domestic Product Good Distribution Practices GACP Good Agricultural and Collection Practices GMP Genetically Modified Products Good Manufacturing Practices

11 The Importance of Standards Benefits: - Protects the patient - Ensure consistency in the medication for the efficacy of disease state treatment - Supply chain integrity - Protects the worker from unsafe operational practices - Provides assurance and accountability to you and your shareholders

12 The Importance of Standards Risks: - Rejected batches - Adulterated products - Product liability - Lawsuits

13 Why Does This Matter To You? Regulations have been constantly changing and being updated Vault requirement (just kidding!) Testing requirements evolving Feels like looking into a crystal ball You may feel like you mine as well ask your neighbor s 4 year-old to attend your next investor meeting to provide insight into what Health Canada will promulgate next

14 Why Does This Matter To You? Good Agricultural and Collection Practices Good Production Practices Good Manufacturing Practices European Good Manufacturing Practices EudraLex Volume 4 Look to Pharma, Cosmetics, Food, Nutraceuticals Industry What do they all have in common?

15 But Current Industry Challenges Still Exist Medicine Lack of research Market Research Clinical Research Consistency Predictability

16 Medicine - We are selling medicinal products - What is the definition of medicine? - How does that compare to what we are selling - Potentially contaminated patients - Drug: the general name of substances used in medicine; any substance, vegetable, animal or mineral used as a medicine. - Medicine: A compound or preparation used for the treatment or prevention of disease, especially a drug or drugs taken by mouth.

17 Lack of Research Market Research What do patients want? What do patients need? What will your customers in the recreational market want and need? Clinical Research What does the science say? Where are clinical trials at? What about product efficacy? Dose response? Best drug delivery method?

18 Product Consistency Herbal drug product What does consistency mean? What do we need to control for? THC? CBD? What about the other 100+ cannabinoids? What about terpenes? Product specifications Based on what? Monograph

19 Predictability How do you plan for the next regulation roll out? How do you stay ahead of the next inspection requirements without overengineering your systems and wasting capital? Packaging and labelling requirements Laboratory testing requirements

20 Predictability Two tips: - Look at the past - Prohibition of Alcohol, Food and Drug Act, Railroads and steel, water quality - Those who cannot remember the past are condemned to repeat it - Look at analogues - Food - Pharmaceuticals and OTC - Nutraceuticals - Botanicals

21 Standards: A Brief History Upton Sinclair The Jungle ASTM Railroads and steel in the 1800s United States Pure Food and Drug Act of 1906 Use of formaldehyde as well as borax, benzoate, sulfites, etc. as preservatives

22 Scalability Training Requirement by EudraLex Volume 4 Chapter 2 Personnel Technology Transfer Canada, EU, beyond Continuous Improvement At the heart of every effective Quality Management System Includes training, education, corrective action/preventative action

23 Where are we today? ACMPR Access To Cannabis for Medical Purposes Regulations CDSA Controlled Drugs and Substances Act FDA Food and Drugs Act

24 What is coming? Cannabis to be removed from the CDSA Decriminalization of fewer than 30 g of cannabis ACMPR licenses continue, with LPs automatically licensed under Cannabis Act to produce, distribute, and sell cannabis for recreational purposes Products: Dried cannabis Oil Plants Seeds NO products with caffeine, ethyl alcohol, or nicotine NO edibles (yet )

25 Framework for the new Regulations 85 recommendations across 5 Themes - Minimize harm of use - Establish safe and responsible supply chain - Enforce public safety and protection - Medical access - Implementation

26 From ACMPR to the Cannabis Act What is likely to be unchanged: Good Production Practice requirements Application of Quality Assurance Personnel Requirements on Import/Export Analytical testing requirements Sales licenses (for medical purposes)

27 From ACMPR to the Cannabis Act What is likely to change: Introduction of micro-cultivation business Research license Security requirements Archive time of security recordings Presence of a security individual Visual monitoring of areas where cannabis is grown Changes to the IHR Expanded license options Cannabis tracking system Introduction of edibles and other consumables (but not right away)

28 From ACMPR to the Cannabis Act What we have no clue about: Taxes Retail selling prices Detailed branding and packaging

29 GETTING LICENSED PRODUCERS READY FOR COMPLIANCE (Part II) ANDREW SAMANN, SGS

30 Cannabis Varieties

31 Genetic Variation Figure from: Cascini and Boschi. (2017)

32 Chemotype Variation Figure from: JT Fischedick, et al. (2010)

33 Anecdotal and Scientific Variation CONCLUSION 4-1 There is substantial evidence that cannabis is an effective treatment for chronic pain in adults. CONCLUSION 4-6 There is insufficient evidence to support or refute the conclusion that cannabinoids are an effective treatment for epilepsy. (The National Academies Press, 2017)

34 National Academies of Sciences, recommendations for Cannabis Pharmacokinetic and Pharmacodynamic Properties Minimum datasets for Clinical and Epidemiological studies with conclusive, actionable evidence Delivery Methods, Concentrations, and Dose Dependent Relationships Standards Development for Manufacturing and Clinical Studies

35 Adulteration A drug is adulterated if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess (Office of the Federal Registrar. 351 (a)(2)(b). Adulterated drugs and devices, Part A )

36 Minimum standards for Chemistry Manufacturing and Controls

37 Monographs and COA s Office of Medicinal Cannabis. (2014). Example of Bluebird Botanicals Batch Certificate of Analysis. Reused with permission.

38 Product Development and Process Management

39 Minimum Elements for Batch Records Dates/ Times Release Equip Deviation Batch Records Batch Number Yields CCP Results Signatures QC

40 Risk Management Risk Management can benefit any process, at a minimum protecting Key Performance Indicators, and at its best, protecting public health and safety. Risk Management can be applied to all stages of the product lifecycle: 1. Product Development 2. Tech Transfer 3. Commercial Manufacturing 4. Product Discontinuation Applying Risk Management to Cannabis manufacturing has few differences from other manufacturing sectors.

41 Quality Management Quality Management is the responsibility of Leaders and Managers. When product quality is poor, all leaders are accountable for not managing the process. Major QMS Elements 1. Deviations 2. Corrective Action and Preventative Action 3. Risk Management 4. Change Management 5. Management Review

42 References 1. F. Cascini, I. Boschi. Tetrahydrocannabinol Concentration and Genetic Characterization of Cannabis. Handbook of Cannabis and Related Pathologies, JT Fischedick, et al. Metabolic Fingerprinting of Cannabis Sativa L., Cannabinoids and Terpenoids for Chemotaxonomic and Drug Standardization Purposes. Phytochemistry, Oct Food and Drug Administration, Center for Drug Evaluation and Research. Botanical Drug Development Guidance for Industry. Dec Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry INDs for Phase 2 and Phase 3 Studies: Chemistry, Manufacturing, and Controls Information. May International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use. ICH Q7: Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients. Step 4, 10 Nov. 2000, /Q7_Guideline.pdf. 6. Office of Medicinal Cannabis. Analytical Monograph Cannabis Flos. Nov TJ Raharjo, et al. Comparative Proteomics of Cannabis Sativa Plant Tissues. Journal of Biomolecular Techniques, The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research. The National Academies Press, 2017.

43 CONTACT US Mohit McLaren Andrew Samann

44 How Quality Assurance is Changing Presented by: Karen Parent Chief Quality and Compliance Officer

45 Discussion Points Regulatory Landscape for LP s (Licenced Producers) Pharma Grade Product What does it take? GMP certification process (who needs it) Compliance, and Regulatory issues. Working with LPs

46 Current Regulatory Framework

47 Regulatory Landscape Right Now... Legal market for fresh and dried cannabis and cannabis oil for medical consumers only Coming (as of July 1, 2018?)... Legal market for non-medical consumers as well

48 Current Regulations ACMPR Access To Cannabis For Medical Purposes Regulations Regulations to the Controlled Drugs and Substances Act Regulated activities: Sale, possession, production, etc. of fresh/dried cannabis and cannabis oil Sale of starting materials to patients or their designates Establish and enforce product and process standards

49 Current Regulatory Framework Licensed Producers may possess, produce, sell, provide, ship, deliver, transport and destroy marihuana or cannabis oil: LPs must be individuals or corporations Licences are site-specific Licences establish maximum quantities Must notify local authorities Security clearance required for specific personnel and for each officer and director (if LP is a corporation)

50 Three Primary Sources of Legal Cannabis 1. Produced/sold by licensed producer 2. Grown by authorized individual 3. Grown by authorized individual s authorized designate

51 Consumer Distribution Patient registers with LP Patient Places Order LP ships to Patient Note: shipping is the only authorized distribution mechanism there must be an order for each shipment in a 30-day period, may not sell more than 30 times the daily limit on Medical Document

52 Good Production Practices Sanitation Pest Management Testing Packaging Record Keeping Labeling

53 Pharma Grade Product GPP Label claim Child-proof packaging Testing finished product No requirement for consistency GMP Label claim Child-proof packaging Testing by phase. Critical Control Points (281) Consistency based on product specifications

54 Examples of GMP Requirements Culture of Quality: QA may lead the process, but QUALITY is everyone s business Product Specifications: Good Production Practices (GPP): No requirements --Product A that a patient receives today could contain a very different THC and CBD value than Product A they purchase next month. Good Manufacturing Practices (GMP): Required: Product A requirements will be the same each and every time - meaning the patient gets a consistent product. Key Documents: Site Master File, Quality Manual, Quality Risk Management Program Validation of suppliers, equipment, IT Systems etc.

55 GMP

56 GPP vs GMP GMP ISO GPP required under the ACMPR Reference: CanniMed

57 Working with LPs

58 Why GMP Certification? To confirm that the management system conforms with all the requirements of the European Union (EU) GACP & GMP legislation and guidelines for the manufacture of herbal drug substances necessary to conduct export activities from Canada to EU member states.

59 Plain Packaging

60 Looking Ahead Licenced Producers interest in becoming cgmp is growing Differentiate Export medical cannabis to Germany and wider EU markets Quality Medical versus Recreational products remains high

61 Thank-you Karen Parent Chief Quality and Compliance Officer

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70 Next Sessions: Cannabis 301 (Webinar) Risk Reduction Seminar led by Pamela Bragg from Sarkany Management Inc The rights, responsibilities & risks to employers regarding cannabis in the workplace. Tangible examples and case studies Impact of medical marijuana on commercial insurance Sponsored by:

71 Next Sessions: Cannabis 401 Edibles In Your Product Line AFTER Legalization: Impact of R&D Insurance Contracts Product Liability Packaging, Website and Sales Sponsored/Presented by: