QnR Associates

The Intelligent Choice

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ACMPR – CONSULTING AND QUALITY ASSURANCE SERVICES OVERVIEW

The rapidly growing billion dollar medical marijuana industry in Canada is rapidly attracting a huge influx of capital investment from both individuals and companies alike. The complex system of regulatory requirements is not only daunting to understand but difficult to follow and extremely costly to correct if not followed properly. Effective April 01, 2014, Health Canada introduced a new system which allows individuals and companies to apply for a license to become a legal producer of medical marijuana under the Access to Cannabis for Medical Purposes Regulations (ACMPR). QnR Associates can guide you through the entire licensing application process to ensure that your facility is fully licensed and in compliance with the Access to Cannabis for Medical Purposes Regulations (ACMPRs).

At QnR Associates we will help you obtain a Producer’s License for the production of medical marihuana under current regulations. We will also ensure that your application is complete and accurate before submitting it to avoid unnecessary delays and costs. We will not only communicate with Health Canada on your behalf but will also guide you through the audit process. Once your application is approved we can help you implement the required Manufacturing, Quality and comprehensive Inventory Control systems. Police clearance and security systems and access control and monitoring as required by the current regulations are also something that QnR Associates can help you with. QnR Associates is your one stop shop for all of your ACMPR regulatory advice.

Our Services

Standard Operating Procedures

  • QnR Associates can produce all the necessary SOP’s to cover your facilities, your equipment as well as your production processes. The end result will ensure that you have a functioning, compliant facility.

Quality Assurance

  • QnR Associates can also provide on-going regulatory and quality support. Our team of qualified QA professionals is always available to address any questions or issues you many have, including investigating deviations, test result failures and identifying root causes and incorporating Corrective and Preventive Actions. We can help you arrange testing of your product to determine its quality, stability and integrity.
  • We have extensive Regulatory and Quality Assurance experience and expertise with both Health Canada and FDA in both regulatory affairs and audits which we will use to guide you through every step of the process.

Support for Section 10 of the ACMPR License Application

  • Quality Assurance Pre-Licensing Report Support
  • Quality Assurance Attestation Support
  • Help in selecting a Quality Assurance Person to support the Licensed Production

Support following recalls or Health Canada observations during audits

  • Lack, Gap, Mismatch Analysis
  • Remediation planning and support
  • QAP mentoring, training and support

GMP PRODUCTION DOCUMENTATION SUPPORT

  • Process validation
  • Equipment qualification
  • Training
  • Batch records
  • Testing validation and interpretation
  • Product release
  • Process flow
  • Cleaning validation
  • Pest control
  • Sanitization procedures
  • Certificates of analysis
  • Certificates of compliance
  • Label proof and approval

PRODUCT DEVELOPMENT MILESTONES

From Idea to Harvest

  • Application

    Overview of Regulatory Requirements and complete the application to become a Licensed Producer

  • QA REQUIREMENTS

    As part of the application, section 10 requires the application to submit the credentials of the proposed Quality Assurance Person (QAP) as well as a Quality Assurance Pre-Licensing Report signed by the QAP

  • Site Audit

    Once the application has been screened and reviewed an inspection date will be established to verify the proposed site information in the Pre-Licensing report

  • Production

    Marihuana, as a Schedule II controlled substance, requires compliance with the Access to Cannabis for Medical Purposes Regulations for the production and sale of Marihuana

QnR Associates – the expertise you need to succeed.

ACMPR – Facts and Figures you should know

2002 - 477
6%
2014 - 38,000
94%

Current number of medical marijuana users approved by Health Canada

Number of patients with personal licenses to grow marijuana for themselves

2001 - 100
4%
March 2014 - 26,500
88%
58,000
Projected Number of Patiens

Health Canada projection of the number of approved medical marijuana patients in 2014

Health Canada projection of the number of approved medical marijuana patients in 2024

up to 450,000
Projected Number of Patients
1.3B per year
Projected Sales

Sales projections for the new industry by 2042

Sources: Health Canada and The Canadian Press, Sept 29, 2013 and 

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