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Understanding International Cannabis GMP's
The road to global cannabis legitimacy is paved with uncertainty—issues like supply chain clarity, consumer and patient safety, privacy, energy, and water usage combined with a lack of applicable GMP's (good manufacturing practice) present a challenging prospect for interested businesses. But some global markets are more refined than others.
For example, in the US, the FDA develops GMP and cGMP (current good manufacturing practice) guidelines for anything related to foods or pharmaceuticals, but the FDA does not currently have any guidelines specific to the cannabis and hemp industry. Without guidance from the FDA, health and quality guidelines development in the US is left to state lawmakers and business owners.
But the rest of the global cannabis market plays by an entirely different set of rules. Australia, for example, regulates its legal medical cannabis industry with the TGA (Therapeutic Goods Administration) run by their Department of Health. Canada has regulatory agencies in each province to oversee cannabis cultivation and distribution; the EU (European Union) relies on WHO (World Health Organization) to standardize GMP's.
The fact is, GMP methods vary extensively from country to country. GMP's are adopted to prevent injury to the end-user or patient. When following GMP's, the product remains free from contamination, and the manufacturing and packaging processes are well documented.
However, GMP's are guidelines, not instructions, and may differ depending on how they're applied. Here's an outline of what the majority of GMP's consist of:
- Precise manufacturing methods are established, and processes are provable and repeatable.
- Modifications to processes must be clearly documented.
- Accurate accounting must be maintained, including a comprehensive batch history of manufacturing and distribution to the end-user.
- Recall procedures must be outlined and available.
- All product complaints must be investigated.
The WHO GACPs are questionable when applied to cannabis. They specifically refer to plant medicine "grown in the wild," not indoors or in a greenhouse. Interpreting these guidelines within the definition of medical cannabis is challenging, adding to the confusion.
PIC/S (Pharmaceutical Inspection Co-operation Scheme) is a global co-operative between regulatory authorities in Good Manufacturing Practice (GMP) of medicinal products for human use. It is open to any country possessing a comparable GMP system and seems like the most likely organization to create a medicinal cannabis GMP; however, the official website does not currently have any policies related to medicinal cannabis.
Businesses must create and follow their own GMP's in the absence of standardized ones for the growing medical cannabis industry.
Here's a handy list of international acronyms:
API(s) - Active Pharmaceutical Ingredients
ASEAN - Association of South East Asian Nations
CHF - Swiss Francs
DIA - Drugs Information Association
EC - European Commission
EEC - European Economic Community
EDQM - European Directorate for the Quality of Medicines
EEA - European Economic Area
EFTA - European Free Trade Association
EMA - European Medicines Agency
EU - European Union
FDA - Food and Drug Administration (US)
FIP - Fédération Internationale Pharmaceutique
GACP - Good agricultural and collection practices
GCP - Good Clinical Practices
GCLP - Good Control of Laboratory Practice
GDP - Good Distribution Practice
GLP - Good Laboratory Practices
GMP - Good Manufacturing Practice
ICH - International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
IFPMA - International Federation of Pharmaceutical Manufacturers Associations
IMID - International Medicinal Inspectorates' Database
ISPE - International Society for Pharmaceutical Engineering
IQ - Installation Qualification
JVP - Joints Visits Programme
MERCOSUR - Mercado Común del Sur
MoU - Memorandum of Understanding
MRA(s) - Mutual Recognition Agreement(s)
NAFTA - North American Free Trade Agreement
OECD - Organization for Economic Co-operation and Development
OQ - Operational Qualification
PA - Participating Authority
PAHO - Pan American Health Organization
PIC - Pharmaceutical Inspection Convention
PIC/S - Pharmaceutical Inspection Co-operation Scheme
PDA - Parenteral Drug Association
QA - Quality Assurance
Q7A - ICH Expert Working Group on Active Pharmaceutical Ingredients
RA - Regulatory Authority
SOP - Standard Operating Procedure
TGA - Therapeutic Goods Administration (Australia)
UNICEF - United Nations International Children's Emergency Fund
WHO - World Health Organization
WTO - World Trade Organization
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