Selling internationally? You need GS1 and GTIN!

GTIN or Global Trade Item Number is a standard from the GS1 (Global Standards) organization. GTIN consists of unique codes that identify manufacturers and their products using barcodes. When scanned by an electronic reader, the GTIN barcode provides a code that is related to a specific manufacturer and a specific product from that manufacturer.

In North American, the UPC (Universal Product Code) is an existing form of the GTIN. In Europe, EAN-13 is the GTIN standard.

The GTIN system lets you and your products be identified across the globe. If you hope to sell in certain parts of the world, such as Europe, you will need to use GS1 standards and GTIN codes. Once you have signed up with your regional GS1 office, you will be issued a series of unique codes to use on your product packaging.

Fully supporting GS1, AirMed prints your GTIN barcodes directly from the database. Our master case processing lets you use multi-level barcoding for several layers of packaging or stock-keeping units (SKU). For example, one case could contain a dozen smaller cartons. Each of those cartons could contain a dozen retail-ready individual packages. All of those packaging layers can have its own barcode to meet the retail standards of the region where it will eventually be sold.

AirMed helps you meet your barcoding and packaging standards whether selling to a provincial warehouse or shipping internationally. AirMed even lets you apply pricing at the package or the master case SKU, and custom pricing can be set for specific SKUs by customer.

For more information on GS1 standards and GTIN barcoding, visit: https://gs1ca.org/

If you’d like to discuss your specific needs, please give us a call at 1-877-313-2442 or click the Request Demo button at the top of the page to start the ball rolling.

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

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.

by AirMed Communications

GS1 Trend Report 2023/2024

Selling any product, including cannabis, starts with a unique identification number from GS1. The GS1 (Global Standards 1) organization is a neutral, global collaboration platform that brings industry leaders, government, regulators, academia, and associations together to develop standards-based solutions to address the challenges of data exchange.

GS1—which has local Member Organisations in 116 countries, over two million user companies and 10 billion transactions every day—helps ensure that there is a common language of business across the globe. GS1 manages the Global Trade Item Number or GTIN, which identifies companies and their products and services using barcode data.

“Trend Research 2023-2024” is a report published recently by GS1 that discusses the top business trends in the world. Topics include data privacy, supply chain digitalisation, traceability and new technologies.

“A cornerstone of any digital transformation are the concepts that are core to the GS1 system: globally unique identification, a common data language, a commitment to interoperability and a firm belief that business value achieved through data sharing is amplified through the use of standards.”

For more information and to download the report visit:
https://www.gs1.org/resources/articles/trend-research-2023-2024-innovation-world-continuous-disruption

by AirMed Comm

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.

To access the resources quoted here, use the following links:

by AirMed Communications

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.”

To read the full articles quoted here, visit the following links:

by AirMed Communications