QMS-GPP Planning According to ISO:9000

Introduction

Quality management is the practice of ensuring consistency in products and services throughout your organization. A Quality Management System (QMS) helps your cannabis business provide customers with the best you can offer while mitigating risks using tools that support Health Canada’s Good Production Practices.

A Quality Management System-Good Production Practices Plan provides an overview of the quality management system that an organization has in place. Although there are many standards in the world, ISO:9000 is one of the most respected. And according to ISO:9000 standards, the plan must contain the following.

Quality Policy (ISO:9000 clause 5.2): A quality statement can be derived from a mission statement and/or vision statement, but should explain the organization’s commitment to quality

Quality Objectives (ISO:9000 clause 6.2): These can be the organization’s objectives from a business plan, again, as long as they contain a commitment to quality

Criteria for Evaluation and Selection of Suppliers: As quality management and good production practices are often dependent on supplies and equipment that come from other organizations, organizations need to have a criteria in place for evaluating their suppliers to ensure that they select suppliers that meet QMS and GPP standards

Scope of the QMS: This is a list of all SOPs with brief descriptions/purposes

Quality Product Statement

ISO:9000 requires your organization’s quality policy to be appropriate to your organization’s strategic direction and operational direction (context).

Your organization must understand and identify all the influences that affect its business and ensure that the strategy and direction takes quality into consideration. Your organization will need to review its current quality policy regularly to ensure that any changes in context, interested parties or other requirements are reflected, and to determine whether your organization’s objectives are affected. (ISO 9001:2015 – 6.2.1a.)

Following is an example.

Company ABC produces cannabis products for distribution in Canada according to the regulations in the Cannabis Act. The Company has developed its production system through experience and its aim is to achieve a high standard of production and products to its customers.

It is the policy of Company ABC to provide the customer with goods to the agreed requirement in accordance with the details and price.

The Directors, Management and Staff are responsible for Quality Control through the Quality Management System seeking improvement by constant review, with suppliers and sub-contractors being encouraged to co-operate. The Company is committed to achieving customer satisfaction by the use of quality procedures which will be operated to meet or exceed the requirements of [the Cannabis Act and/or ISO 9001 or other quality system].

Quality Objectives

The quality objectives should act as a driver for continual improvement. To meet quality standards, your organization will be required to ensure that you continually improve products and services to meet customer requirements and to measure effectiveness of the processes responsible.

Following is an example.

Company ABC strives to be the best provider of cannabis products in Canada. Through the use of this guiding principle, everyone in Company ABC is accountable for fully satisfying our customers and authorities by meeting or exceeding their needs and expectations with best-in-class production practices. Our goal is 100% customer satisfaction and compliance 100% of the time.

Our Quality Policy is defined and strongly driven by the following objectives:

1. Meet all compliance requirements for all levels of governments and regulatory agencies

2. Build a mutually profitable relationship with our customers, ensuring their long-term success, through the understanding of their needs and the needs of their customers as well

3. Achieve our commitments for quality, cost, and schedule

4. Use of best preventive practices at all levels and ensure reliable risk management

5. Drive continual improvement and innovation based upon efficient business processes, well-defined measurements, best practices, and customer surveys

6. Develop staff competencies, creativity, empowerment and accountability through appropriate development programs and show strong management involvement and commitment

Evaluation and Selection of Suppliers

Supplier evaluation is a system for recording and ranking the performance of a supplier in terms of a variety of criteria and is a must in ISO:9000. A process of vendor rating is essential to effective purchasing. While there is no one right system for supplier evaluation and selection process, the overall objective is to reduce risk and maximize overall value to the purchaser.

Criteria

There are eight common supplier selection criteria:
1. Cost
2. Quality & Safety
3. Delivery
4. Service
5. Social Responsibility
6. Convenience/Simplicity
7. Risk
8. Agility

In the cannabis industry, you should also add a commitment to meeting compliance and/or helping their customers meet compliance.

Methods

There are many other methods of evaluation, and the organization should determine which is the best for its use.

Categorical systems typically use excellent, good, average, poor and so on.

Weighted systems rate on a scale from 1 to 10 or out of 100.

Hierarchical systems give values in relation to each item’s importance. The most important item is given the highest value.

Conclusion

Of course, a quality management system and good production practices plan is only as good as the processes that support it. Creating standard operating procedures and ensuring that all personnel follow them will give you the best chance of success.

For more information about ISO:9000 visit: ISO – ISO 9000 family — Quality management

For information on how AirMed helps you meet compliance, visit our Compliance page.

If you’d like to learn about our quality management and GPP offerings or discuss your specific needs, please give us a call at 1-877-313-2442 or use one of the contact forms.


AirMed and FDA CFR 21

We are sometimes asked if AirMed meets FDA standards. First, please be aware that the FDA is a department of the US government. The specific portion of FDA regulations relevant to software such as AirMed is part CFR 21. As it is an American standard, Health Canada does not require CFR Part 21 compliance as part of the Cannabis Act Regulations. And while AirMed was designed for the Canadian cannabis industry and to comply with Health Canada regulations, AirMed does conform to CFR Part 21 with respect to electronic record keeping, audit trails, and electronic signatures. 

Many agencies throughout the world are responsible for issuing and enforcing regulations that affect businesses. The regulations affecting software such as AirMed are typically those related to records management compliance. And while there are many regulatory agencies involved in records management, for the most part the regulations themselves are similar from country to country and agency to agency. The purpose of them, in general, is to ensure the security, confidentiality and authentication of electronic records.

The U.S. FDA regulates food, drugs, medical devices, biologics, animal feed and drugs, cosmetics and radiation-emitting products such as cell phones for the U.S.A. The FDA’s rules for manufacturing and distribution are designed to protect consumers and promote public health. In the U.S. Code of Federal Regulations (CFR), Title 21 deals with Food & Drugs. Until recently, the regulations in this title required paper records with handwritten signatures.

Back in 1997, part 11 of 21 CFR was enacted to cover the use of electronic records and electronic signatures. Commonly known as 21 CFR 11, this part defines the criteria “under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.”

Essentially, the concerns about using electronic records are that records may be lost in a system crash, the data may become corrupt or modifications may be made without proper authorization. In addition, since printed documents with hand-written signatures are recognized as legally binding on the signators, the agencies are looking for ways to make electronic records similarly binding on their owners. The regulations have been proposed to ensure that whenever an organization replaces printed documents with electronic data, there are checks and balances in place to ensure integrity of the electronic records so that they can be legally equivalent to printed records.

AirMed has a range of features that satisfy standards for security, authentication, validation and auditing as outlined in 21 CFR 11 and other regulations.

For more detailed information visit: Code of Federal Regulations (CFR) | FDA

For more information on how AirMed helps you meet compliance, visit our Compliance page or our Frequently Asked Questions page. If you’d like to discuss your specific needs, please give us a call at 1-877-313-2442 or use one of the contact forms to start the ball rolling.


FREE Seed-to-sale Software Buyer's Guide

Record keeping is an essential part of Health Canada’s compliance regulations. From the advent of legal medical marijuana in Canada, legal producers of cannabis have been required to track every seed, rooted plant, gram of waste material, final dried product, as well as interactions with customers and more. Due to the sheer volume of information, an electronic record-keeping system is the only practical way to manage the process. The software industry has responded to this need by creating seed-to-sale management software systems designed to help producers track their operations and report to Health Canada to meet compliance.

To help you through the process of purchasing seed-to-sale software in the Canadian Cannabis marketplace, we’ve produced a 20-page guide that answers the following questions:

  • What is a seed-to-sale software solution and why do I need one?
  • How do I choose one software platform over another?
  • What should I be looking for in the software?
  • How does the software fit into my business?
  • How is my data stored and secured?
  • What happens if regulations change?

To download this guide courtesy of AirMed, please visit the following page and complete the form. Once you submit the form, you’ll be able to download the guide.

AirMed Seed-to-Sale Software Buyer’s Guide


Canadian Greenhouse Conference 2023: Oct 4-5 in Niagara Falls

Your Canadian resource for the business of growing
As Canada’s foremost event for commercial greenhouse flower, vegetable, cannabis, berry and nursery growers, the Canadian Greenhouse Conference is the ultimate connection point for growers, suppliers and research partners.

The Canadian Greenhouse Conference is a not-for-profit corporation and Canada’s foremost event and connection point for commercial growers of crops produced in a controlled environment. The conference attracts growers from across North America, gathers experts from around the world and showcases innovative production techniques, research, products and technology.

Being held October 3-4, 2023 at the Scotiabank Convention Centre in exciting Niagara Falls, Canada, the Canadian Greenhouse Conference offers two days of informative, motivating sessions and a large trade show with over 300 booths.For more information visit: https://www.canadiangreenhouseconference.com/


Complete C3 Excise Tax Survey of Licence Holders before Sep 1

Cannabis Council of Canada (C3) is conducting a study on the Canadian cannabis excise tax framework and are looking for input from licensed producers and processors from across the country.

Are you a Health Canada Licence Holder? Please take 10 minutes to fill out an anonymous survey (or forward to your CFO) before September 1st and join C3 August 31st for a virtual discussion with other leaders in the cannabis sector.

“Your input will be invaluable in shaping our conversations with government decision-makers at an upcoming lobby day and in advance of the Fall Economic Statement. All responses are anonymous and will be reported in aggregate.”

Not a licence holder? C3 encourages you to share this survey link with LPs whose operations might be impacted by a change to the excise tax framework.

Use the link below to complete the survey:
https://qfreeaccountssjc1.az1.qualtrics.com/jfe/form/SV_25f1c7xf8k9fhoq

Or visit C3 for more information:
https://cannabis-council.ca/


Grow Up Victoria 2023: Oct 1-3

Grow Up Conference and Expo is returning to Victoria BC, October 1-3, 2023. This west coast show will bring over 120 high-level industry speakers, 90+ exhibitors and thousands of delegates together on Vancouver Island.

With over 100 world-class speakers, the informative panels will bring you up-to-speed with what is happened in the cannabis cultivation and extraction industry, nationally and abroad. Sessions are dedicated to the hottest topics, latest trends and the future of cannabis.

Network with LPs, head growers, extractors, retail, budtenders, purchasing agents, distributors, suppliers, manufacturers and more. The Masterclass Technical workshops series will elevate your growing with sessions designed to go in-depth to cannabis cultivation and extraction.

This in-person event is scheduled for October 1-3, 2023 at the Victoria Convention Centre in downtown Victoria, BC, Canada.
For more information visit: https://growupconference.com/


Exporting Cannabis to the EU

In a previous post, we discussed how some Canadian producers are selling excess inventory to export markets, including Europe.

In “The Europe Medical Cannabis Market,” Market Data Forecast reports, “The medical cannabis market in Europe is expected to grow from USD 4.96 billion in 2022 to USD 13.37 billion by 2027, growing at a CAGR [compound annual growth rate] of CAGR 21.96% from 2022 to 2027.”

Based on that report, Europe appears to be a significant marketplace for cannabis. But to sell into that market, the exporter must meet the region’s standards. In the case of Europe, those standards include the European Union’s Good Manufacturing Practices, referred to as EU GMP.

In their article, “A Look at Canadian Cannabis Exports,” published in 2021, The Business of Cannabis reported one reason why exports jumped in 2020. “In Canada, more cultivators gained the European Union’s Good Manufacturing Practices (EU GMP) certification, allowing them to export to that continent. More than a dozen Canadian LPs now have EU GMP certified facilities.”

Meeting EU GMP standards is critical for exporting into the European marketplace. But what is EU GMP and how does it differ from the standards Canadian companies already meet?

Health Canada requires that Canadian licensed producers comply with Good Production Practices or GPP standards. If you are a licensed producer in Canada, you are already familiar with GPP. If not, these standards are explained on the Health Canada website.

Essentially, GPP requires that cannabis businesses have appropriate procedures for all activities related to producing a product that is safe for public consumption. GPP mandates that systems be in place to ensure quality and traceability.

Good Manufacturing Practices, GMP, takes GPP further including requiring more stringent testing.

The Foundation of Cannabis Unified Standards (FOCUS) states, “GMP is the proactive part of quality assurance. It is designed to minimize the risks involved in all steps of the manufacturing process. A basic tenant of GMP is that quality cannot be tested into a product. It must be built into each batch of product during all stages of the manufacturing process.”

Originally designed for pharmaceutical products, GMP can be applied to any production process and is a requirement for those wishing to market medical cannabis in Europe.

The EU GMP standards are complex, and the information can be difficult to navigate, especially how it applies to cannabis.

But the Canadian government has published guidelines designed to help manufacturers meet GMP standards. Their guidance document has been written “with a view to harmonize with GMP standards from: the World Health Organization (WHO); the Pharmaceutical Inspection Cooperation/Scheme (PIC/S); the International Council on Harmonisation (ICH); the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); other regulatory agencies in other countries.”

While the EU is not mentioned specifically, these Canadian standards are a good starting point for cannabis companies considering exporting into other markets. These guidelines will help producers understand what is required and can be used as a stepping stone toward EU GMP certification.

According to the media, the EU standards are stringent, and certification can be time consuming and costly. But with a market as large as Europe, Canadian companies are in a position to benefit from the opportunities that an EU GMP certificate can offer.


Can Canadian Producers Export Excess Supply?

With media reporting oversupply challenges in the Canadian cannabis industry, can producers turn to export markets to sell their inventory? The answer might be yes. As countries around the world legalize cannabis, new opportunities are emerging for producers in Canada.

Canadian companies have been exporting cannabis for several years already. In fact, back in June 2020, MJBizDaily published a two-part article on Canada’s export of medical cannabis during 2019. Part 1 was titled, “Canada exported record amount of dried cannabis in 2019…” Part 2 reported, “Canadian exports of medical cannabis oil jumped fivefold in 2019.”

Canadian Regulatory Review reported in September of 2020 that the Canadian government had even become supportive of cannabis exports. “On the export side, and to further bolster trade, as of January 2020, the federal government through Canada’s Trade Commissioner Service extended trade commissioner services for Canadian cannabis companies exporting cannabis for medical and scientific purposes.”

A few months after that article, in April 2021, Prohibition Partners released a report called “Revealed: The Canadian Cannabis Export Market for 2020.” The report notes that the largest export markets for Canada at the time were Germany, Australia, Israel and the United Kingdom. “…new data shows a huge increase in the exports of cannabis from the country in 2020, as well as a changing network of countries that are importing from established producers in Canada.”

In May of that same year, Business of Cannabis took “A look at Canadian cannabis exports,” noting that “Dried cannabis flower and cannabis oil exports more than doubled in 2020, while imports dropped to virtually zero…”

An article titled, “How Canada’s Oversupply of Cannabis Is an Export Opportunity,” was published in October of 2022 by Canadian Cannabis Exchange. “As the demand for cannabis legalization increases internationally, Canada has the opportunity to become the world leader in cannabis exports… The European Union is proving to be a lucrative market for Canadian exports.”


Montreal Cannabis Expo 2023: Sep 13-14

Being held at the Palais des congrès September 13-14, 2023, the Montreal Cannabis Expo is Quebec’s premier event for the cannabis industry.

Join like-minded industry professionals working in all aspects of the Cannabis Industry, including Licensed Producers, growers, investors, suppliers, healthcare providers, job-seekers and media at this premier event showcasing the best products, services and world-class speakers the industry has to offer. This is the place to learn and share everything there is to know about the cannabis industry.

For more information visit:  https://www.cannabisexpomontreal.com/


Stratcann: Micros Could Surpass Standards in Canada Next Year

According to an article published by Stratcann, “At the current pace of licensing, the total number of micro licences could surpass standard licences in 2024.”

Stratcann, an online news publication covering the evolution of the legal cannabis industry in Canada and around the world, reported that “Micro cannabis licences continue to grow in popularity in Canada, at almost 42 percent of all licences issued as of March 31, 2023. Just over half (51 percent) of licences were standard, three percent were nursery licences, and nearly four percent were medical-sales only licences.”


Report: Medical Cannabis Access and Experiences in Canada

The Medical Cannabis Access Survey Summary Report, issued in April of 2023, provides an in-depth view of individuals currently taking medical cannabis in Canada and their access experiences.

Topics covered by the report include:

  • Changes in Medical Cannabis Use Since Implementation of the Cannabis Act
  • Retention of the Medical Cannabis Program and Needed Improvements
  • Perceived Improvements to the Medical Cannabis Program

This report was formulated from results drawn from the Medical Cannabis Access Survey, which received ethical approval from the University of Manitoba Research Ethics Board 1 and McGill University Research Ethics Office of the Faculty of Medicine and Health Sciences.

For more information and to download a copy of the summary report, visit: https://www.medicalcannabissurvey.ca/report


We’re streamlining so you can work faster

AirMed 5, due out this year, streamlines processes so that you can work faster and more efficiently.

Each action workflow has been redesigned to minimize the number of clicks required to complete the step. Comments are available in a pop up, and lists can be auto populated by scanning a barcode. To select a location, it’s possible to scan the barcode for a room, table, or container, and all the pick-list values will be selected.
Smart input fields ensure erroneous data cannot be entered. If the database contains only a certain number of items, the system will not allow a higher number to be entered. Date fields are automatically restricted based on other data in the system so that it becomes impossible to back-date an item to a date before the item was recorded in the system.

Required fields in action dialogs are available on the first screen the user encounters. And AirMed 5 extends the actions menu with a carousel to show Actions, Reports, SOPs, and Forms. The Report, SOP, and Form sections have customizable lists where users can select the items that are relevant to them.

For more information on these new features or to book a demo of AirMed to see them for yourself, click the Request Demo button at the top of the page or use any of the contact forms.

In the meantime visit our Software page.


Thanks for visiting us at Lift Expo Toronto 2023!

The Toronto Lift Conference and Expo for 2023 happened last week at the The Metro Toronto Convention Centre.

What a great event with leading-edge content, live music, celebrity cameos, prize giveaways and more.

We’d like to thank everyone who dropped by our booth in the expo hall. We greeted as many of our customers (current and future!) as we could, and our team gave everyone a preview of the exciting changes happening to AirMed.

Thanks again for making Lift 2023 Toronto such an  amazing experience for us.

For more information visit: Lift Expo

If you want a reminder of what AirMed has to offer for 2023, visit https://airmedcloud.com/intro-airmed-5/

For a personal tour of our software by one of our team members, click Request Demo at the top of the page or use the contact form in the footer.


See you this Friday at Lift Expo Toronto 2023!

The Toronto Lift Conference and Expo for 2023 is happening this week at the The Metro Toronto Convention Centre.

This event promises leading-edge content, live music, celebrity cameos, prize giveaways and more.

We’re setting up to greet as many of our customers (current and future!) as we can in booth 1023 in the expo hall. Our team can’t wait to show you the exciting changes to AirMed in person on Friday June 2.

For more information visit: Lift Expo

Certified Budtenders get free admission to the expo! Click here for more information: https://liftexpo.ca/tickets-toronto-2023/

If you want an advance peak at what AirMed has to offer for 2023, visit https://airmedcloud.com/intro-airmed-5/

For a personal tour by one of our team members, click Request Demo at the top of the page or use the contact form in the footer.


Cannabinoids in Clinical Practice Conference: Jun 22-23 in Toronto

This two-day conference presents practical evidence-based education on cannabinoid therapeutics with presentations by Canadian and internationally renowned experts.

This event is billed as the “most comprehensive forum on the science behind cannabis, its potential therapeutic benefits and the societal and health impacts of legalization of non-medical cannabis from leading researchers and physicians in the field.”

As a hybrid conference, you can attend virtually or in-person at the Hart House in Toronto, Ontario, Canada.

For more information visit:  https://ccic.net/ccic-conference/


Cannabis Prospect Interviews AirMed CEO Justin Hearn

Cannabis Prospect interviewed AirMed Canada Systems Inc. president and CEO Justin Hearn for an article published on the magazine’s website on May 15, 2023.

In the feature, titled “How AirMed is Helping Canadian Cannabis Producers Cultivate Success,” Hearn discussed the ways AirMed software is adapting to the changing market conditions.

“Our new AirMed 5 version focuses on streamlining data entry and improving quality management and profitability for cannabis operations… We’ve modelled the workflows on commonly accepted manufacturing procedures and terminology incorporating task-based work orders that let organizations precisely track the costs incurred for running their facilities.”

Hearn goes on to say, “AirMed is adapting its software to support increased insight as well as new strategies to boost efficiency, reduce costs, and improve the bottom line.”

Read the full interview here: https://cannabisproonline.com/article/

Download a PDF of this article: Cannabis Prospect Justin Hearn Interview PDF

For more information on AirMed 5, visit: https://airmedcloud.com/intro-airmed-5/


Lift Expo Toronto 2023 fast approaching Jun 1-3

The next Lift Expo is only weeks away taking place this June 1-3, 2023. Thousands of cannabis industry members are expected at this event being held at the The Metro Toronto Convention Centre.

Lift begins with the business conference on June 1, followed by an industry day on June 2.

Visit AirMed and hundreds of other exhibitors at the expo. Our team can’t wait to show you the exciting changes to AirMed in person in booth 1023 on June 2.

For more information visit: Lift Expo

If you are a Certified Budtender, your admission to the expo is free! Click here for more information: https://liftexpo.ca/tickets-toronto-2023/

For an advance peak at what AirMed has to offer for 2023, visit https://airmedcloud.com/intro-airmed-5/

For a personal tour by one of our team members, click Request Demo at the top of the page or use the contact form in the footer.


The European Cannabis Report for 2023

Published by Prohibition Partners, The European Cannabis Report: 8th Edition, 2023, provides the latest information and analysis on the development of the cannabis markets across Europe.

“Included in the report are deep dives into all key sectors and geographic regions in the European cannabis industry, with many data sources which have been exclusively obtained by Prohibition Partners, or else remain un-reported to date.”

For more information, including how to download a free copy of the report, visit:
https://prohibitionpartners.com/reports/the-european-cannabis-report-8th-edition/


Cannabis Council Packaging Webinar Apr 28

The Cannabis Council of Canada (C3) is hosting a webinar April 28 on Health Canada Packaging and Labelling Requirements for Cannabis Products and Other Regulatory Issues.

Health Canada is “seeking feedback on potential amendments to the Cannabis Regulations (CR) for regulatory burden reduction while still addressing public health and public safety risks”. C3 is hosting a series of insightful and engaging listening sessions designed to address the consultation focus areas.

These sessions will provide a unique opportunity for professionals in the cannabis industry to come together, share insights, and collaborate on a unified response to the proposed regulatory changes.

On April 28, 2023 at 1 pm ET/10 am PT, C3 invites you to join series host Ika Washington (Diversity Talks) and a panel of diverse industry leaders as they explore issues related to packaging and labelling requirements for cannabis products. This session will also explore options to press for change in other regulatory areas. Join in and explore the possibilities together!

Ika will be joined by panelists, Megan McCrae (Organigram, C3 Board Member), Shauna Levy (Madge and Mercer Brand) and Serena Somani (4K Cannabis Retail.)

For more information visit: https://cannabis-council.ca/hcconsultation


Grow Up Edmonton 2023: May 28-30

Due to numerous requests from LPs, micros and craft growers, along with some of the largest cannabis retail stores in the nation, Grow Up has decided to bring its show to Alberta. Grow Up will host its 7th conference and expo at the Edmonton Convention Centre from May 28-30, 2023.

Grow Up Conference has been a privately owned Canadian company since 2017 and is a true B2B cannabis event focusing on cultivation, extraction and psychedelics. You will be surrounded by industry professionals with plenty of opportunities to make new connections.

This in-person event is scheduled for May 28-30, 2023 at the Edmonton Convention Centre in downtown Edmonton, Alberta, Canada.
For more information visit: https://growupconference.com/