ARA Avanti Rx Analytics

Medical Marijuana Quality Assurance & Regulatory Services


As of August 24, 2016, the Access to Cannabis for Medical Purposes Regulations (ACMPR) was replaced the Marihuana for Medical Purposes Regulations (MMPR)


The Access to Cannabis for Medical Purposes Regulations (ACMPR) contain four parts:


Part 1 is similar to the framework under the MMPR. It sets out a framework for commercial production by licensed producers responsible for the production and distribution of quality-controlled fresh or dried marijuana or cannabis oil or starting materials (i.e., marijuana seeds and plants) in secure and sanitary conditions.


Part 2 is similar to the former MMAR regime. It sets out provisions for individuals to produce a limited amount of cannabis for their own medical purposes or to designate someone to produce it for them.


Parts 3 and 4 include:


  • Transitional provisions, which mainly relate to the continuation of MMPR activities by licensed producers.

  • Consequential amendments to other regulations that referenced the MMPR (i.e., Narcotic Control Regulations, New Classes of Practitioners Regulations) to update definitions and broaden the scope of products beyond dried marijuana.

  • Provisions repealing the MMPR and setting out the coming into force of the ACMPR on August 24, 2016.

Health Canada is now accepting applications from individuals who wish to register to produce a limited amount of cannabis for their own medical purposes or to designate someone to produce cannabis for them, whilst Health Canada will continue to accept and process applications to become a licensed producer that were submitted under the former MMPR.


Furthermore, all licences and security clearances granted under the MMPR will continue under the ACMPR, which means that licensed producers can continue to register and supply clients with cannabis for medical purposes. New applicants can continue to apply for licences to produce medical marihuana under the ACMPR.


The Licensed producers (LPs) under the ACMPR shall still be subject to regulatory requirements related to security; good production practices (GPP); packaging, labelling and shipping; record keeping and reporting; and distribution. Prior to the issuance of a licensed producer license the site will be subject to Health Canada inspections.



ARA – Avanti Rx Analytics can prepare or help you to prepare your application to become a licensed producer under the new ACMPR regulation and provide expert guidance on how to meet the security, record keeping, prepare the Quality Assurance Report (QAR), and GPP requirements, including the preparation of the Standard Operating Procedures (SOPs) and quality manual.


Our QA and Regulatory experts comprise a powerful blend of consultants with Health Canada, FDA, and industry experience including leading scientific and technical experts whose guidance and recommendation are not only scientifically and technically accurate, but also actionable.


We work with our clients to design and implement effective, efficient, and current processes that assures sustainable compliance by integration of scientific, technical, and regulatory principles.


At ARA, we work with businesses that are focused on the progress of medical marijuana industry, as against those who work solely for profit motive. Our team will help your business to achieve its goals while adhering by the laws that govern the marijuana or cannabis trade at different levels.


The consulting services offered by ARA – Avanti Rx Analytics include:


Facility Design and Process Implementation


Based on our proprietary state-of-the-art technology, we can help our clients in designing and implementing productive indoor cannabis cultivation facilities. Our years of experience and knowledge of the marijuana industry help us create optimum growth rooms for your crops and make them reach their full potential.


After identifying ideal space and surrounding area for your cultivation, we will work with you to implement an innovative crop growing facility. We can direct architectural and mechanical design as well as sourcing the suitable equipment required for successful indoor cultivation whilst meeting the compliance requirements for your licence.


Regulatory, Compliance, and Licensing


Assisting our clients to obtain their Health Canada Licence for production of medical marihuana is one of our major services that includes:


  • Helping to interpret ACMPR regulations in concert with industry standards

  • Preparation and submission of ACMPR application to Health Canada

  • Participation in Health Canada audits of client’s facility and systems

  • Evaluate and facilitate the resolution of complex exclusivity issues involving ACMPR application and related regulatory and compliance issues to ensure timely approval process

  • Preparation and evaluation of written procedures, policies, and standard operating procedures (SOPs)

  • Preparation of Quality Report

  • Creating a program to meet current Health Canada’s expectations for GPP Compliance

  • Provide expert scientific guidance to understand and resolve significant issues related to any regulatory observations and warning letters in order to ensure timely resolution of complicated scientific, technical, and/or compliance issues raised by Health Canada application reviewer.

  • Develop and deliver specialized hands on trainings

  • Reviewing and enhancing management controls

  • Performed due diligence audits of applications in association with the ACMPR regulation

  • Provide expert consultant services for development and execution of numerous remediation/voluntary corrective action plans, which have been accepted by the Health Canada

  • Facilitation of a new facility construction review/s for clients with the Health Canada


Proposed List of SOPs for Medical Marijuana Producers


No.

SOP

1 Standard Operating Procedures (SOPs)
2 Employee Training Program
3 Employee Health and Safety
4 Employee Hygiene
5 Good Documentation Practices
6 Record Keeping
7 Change Control (CC) Program
8 Investigation of Out of Specification (OOS) Results
9 Deviation Management Program
10 Corrective and Preventative Action (CAPA)
11 Product Complaints Program
12 The Operational Variance Report (OVR) Program
13 Product Recall Program
14 Post – Market Surveillance
15 Qualified Person in Charge (QPIC)
16 Good Production Practices (GPP)
17 Responsibilities of the Quality Unit and Personnel
18 Supplier Audit/Inspections
19 Senior Responsible Person in Charge (ARPIC)
and Responsible Person in Charge (RPIC)
20 Self-Inspection Program
21 Validation Program
22 Equipment Calibration and Maintenance

No.

SOP

23 Validation of Computerized Systems
24 Process Validation
25 Analytical Method Validation
26 Medical Marijuana Product Specification
27 Analysis of Medical Marijuana
28 Material Receiving, Handling, Sampling and Testing
29 Disposition (release) of Finished Products
30 Retained Samples Policy
31 Product Over Labelling
32 Orders and Distribution Records
33 Inventory Control
34 Warehousing/Material Management/Inventory Controls
35 Handing of Damaged and Returned Products
36 Security Measures for Handling Medical Marihuana
37 Medical Marihuana Storage
38 Destruction of Marihuana Plant Waste
39 Facility Maintenance and Sanitation
40 Facility Security and Security Access
41 Environmental Controls:
Air Handling (HVAC) and Water System
42 Facility Pest Control Program
43 Visitors
44 Medical Marihuana Transportation