Cannabis & GMP/GACP: Part 3 - Cannabis & Standards

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.