Canadian Producers & Standards

The Canadian cannabis industry is regulated by Health Canada, who have supplied both recordkeeping standards and good production practice standards. Licensed producers (LPs) must describe how they will meet those standards at the time of licensing.

When Health Canada was developing regulations for cannabis, they realized that existing standards did not cover the specific aspects of cannabis production and distribution. As a result, the government created a new quality system designed explicitly for cannabis in Canada, called Good Production Practice (GPP).
GPP was based on the existing standards outlined in Good Manufacturing Practice (GMP) and Good Agricultural and Collection Practice (GACP) – combining portions of both.

But when other governments were considering cannabis regulations, they chose not to create a new standard. The European Union, for example, chose GMP for cannabis. Australia did as well. But Israel chose GACP for cannabis.

Canadian companies looking to export will need to meet the standards for the specific region even thought they already meet GPP.

As a result, they should be knowledgeable of all three of the main quality systems that are applied to cannabis.

• Good Production Practices (GPP) designed for cannabis in Canada
• Good Agricultural and Collection Practices (GACP) designed for agricultural products in various regions
• Good Manufacturing Practices designed for pharmaceutical & herbal medicines in various regions (Current GMP or cGMP in the USA)

GMP Requirements

GMP has been the leading standard for pharmaceuticals for decades and is now the leading standard for cannabis outside of Canada. GMP has the following basic principles.

1. Clearly defined processes (standard operating procedures or SOPs)
2. Proper documentation including instructions for all equipment
3. Premises that are adequate for the operations
4. Equipment that is suitable for the activities carried out
5. Appropriately trained & qualified personnel
6. Standardized manufacturing processes
7. Verified sampling & testing
8. Correct materials including packaging & labelling
9. Safe storage & transportation
10. A satisfactory complaint and re-call system
11. Validation of all critical steps
12. A quality management system to oversee all practices

GACP Requirements

Good Agricultural & Collection Practices is a recognized standard around the world for cultivating agricultural products for human consumption. GACP has the following basic principles.
1. Formal Standard Operating Procedures (SOPs)
2. Proper documentation
3. Premises that are adequate with emphasis on cleanliness, good ventilation & protection for the product
4. Equipment that is suitable, regularly maintained and cleaned to avoid cross-contamination
5. Qualified personnel who have hygiene, botanical & quality control training
6. Standardized cultivation practices & inputs that guarantee consistency & high quality
7. Verified sampling & testing
8. Appropriate processing & packaging
9. Safe storage & distribution
10. Trustworthiness of seeds & propagation materials
11. Risk-free collection & harvesting
12. Reliable batch identification & traceability, which is mandatory to guarantee lot homogeneity

GMP vs GACP

As you can see by comparing the two lists above, GMP and GACP share several basic principles.

The differences between them are that GMP begins after the production of raw materials. GACP covers propagation, cultivation and harvesting plus packaging and storage but not processing. GACP also does not account for drug or therapeutic properties, which GMP does.

In addition, GACP does not require a formal quality management system, which is mandatory for GMP. GACP also does not require validation of software and equipment, also mandatory for GMP.

For a complete list of the requirements of each quality system, please refer to the websites for each standard.

When you read the detailed requirements for GMP and GACP, you will find that there is overlap. In fact, many of their requirements are also required by GPP. Therefore, Canadian LPs are already meeting some of the requirements of both GMP and GACP.

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.