Cannabis & GMP/GACP: Part 2 - Quality Systems

Welcome to our summer series on cannabis and GMP/GACP. A new article will be published once a week throughout the summer. You can access related articles that have been published so far by clicking the Compliance category on the main News & Events index page: Compliance category

Cannabis Around the World

The legality of cannabis varies from around the world. In some regions, cannabis is licensed for both medical and recreational use. In others, cannabis is licensed for medical use only. And in some, cannabis remains a prohibited substance for any use.

At the time of writing this, 50 nations had legalized cannabis nationally or regionally for medical or recreational use. Each individual region sets the standards for cannabis production, manufacturing and distribution.

The types of standards that are applied to cannabis are collectively known as ‘quality systems.’ Most quality systems are similar to each other, using accepted good practices. What differs are the processes they cover, which are dependent on the products being manufactured.

In many cases, the standards applied to cannabis are based on pre-existing quality systems designed for other types of manufacturing or production. Since the plants are grown in an agricultural setting, agricultural standards, such a Good Agricultural & Collection Practice (GACP), can be applied. As cannabis has drug qualities and therapeutic value, pharmaceutical standards, such as Good Manufacturing Practice (GMP), can be applied. With testing for THC and other values, clinical or laboratory standards can be applied. As well, general business standards, such as those from the International Organization for Standardization (ISO), can also be applied.

New standards, however, can be created at any time. When Canada was legalizing cannabis, Health Canada created a new quality system designed specifically for cannabis called Good Production Practice (GPP).

When other regions were considering cannabis, however, most decided not to create a new standard as Canada did and chose GMP or GACP instead.

Each of these quality systems has the same type of framework. Rather than rigid rules, most standards provide guidelines for carrying out operations. The standards are not designed to limit how a business operates. Instead, they are intended to guide the facility toward good practices. The ‘how’ of complying is left up to the individual organization. Each facility is allowed to determine the best way to meet the criteria. The final result is what is important.

Quality Standards Benefits

Besides meeting compliance regulations, adhering to a quality system offers many benefits, including increased productivity, improved employee safety, and enhanced customer satisfaction. But one of the main purposes of standards in relation to cannabis is to minimize the following risks.

  • Contamination of products that could make them unsafe.
  • Inaccurate labelling that could lead to accidental misuse.
  • Insufficient active ingredients that could affect efficacy.
  • Excess active ingredients that could be hazardous.

These risks are the reason cannabis operations must comply with a quality system, regardless of where they are in the world. There may be one governing body with one set of standards clearly laid out. In other cases, there may be several sets of standards that focus on different areas of operation. When setting up a facility, each cannabis business must identify which standards will apply and how to meet them.

by AirMed Comm

ISO, SCC and the Canadian Cannabis Industry

ISO, the International Organization for Standardization, is an independent, non-governmental international organization with a membership of 170 national standards bodies.

Through its members, ISO brings together experts to share knowledge and develop voluntary, consensus-based, market relevant International Standards that support innovation and provide solutions to global challenges.

In Canada, the ISO is represented by the Standards Council of Canada (SCC). A Crown corporation, SCC was established by an Act of Parliament in 1970 to foster and promote voluntary standardization in Canada. SCC is independent of government in its policies and operations, although it is financed partially by Parliamentary appropriation.

When Canada legalized cannabis in 2018, SCC set about creating standards for the new industry believing that standards are essential for an effectively regulated marijuana market. These standards were considered groundbreaking when published in October of 2022.
ISO IWA-37, “Safety, security and sustainability of cannabis facilities and operations” is available for purchase through ISO in three parts.

Part 1 (ISO IWA 37-1:2022) covers requirements for the safety of cannabis buildings, equipment and oil extraction operations. https://www.iso.org/standard/84023.html

Part 2 (ISO IWA 37-2:2022) covers requirements for the secure handling of cannabis and cannabis products. https://www.iso.org/standard/84024.html

Part 3 (ISO IWA 37-3:2022) covers good production practices (GPP). https://www.iso.org/standard/84025.html

Taken as a whole, these documents provide invaluable direction to legislative bodies and emerging companies and help to create a safe, legal market for adults who use cannabis.

For more information from SCC visit: https://www.scc.ca/en/news-events/news/2022/new-guidance-from-iso-international-workshop-safe-cannabis-production

For more information from ISO visit: https://www.iso.org/en/contents/news/2022/10/standards_safe_legal_cannabis.html

To learn more about how AirMed helps you meet these standards, 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.

by AirMed Comm

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.

by AirMed Communications