Good Manufacturing Practices (GMP & EU GMP)
Cannabis production has become one of the most prominent emerging industries in the world. Having been studied for more than 100 years, the cannabis plant provides a reservoir for a variety of molecules leading to opportunities for the development of new products and pharmaceutical advancements. Cannabis business development is generating multi-faceted innovation from previously controversial activities accomplished behind the scenes in the black market.
Canada is the only country of the G7 that has legalized cannabis throughout its territory. Through strict regulations, Canadians can now produce, process, sell, analyze or research cannabis. The rest of the world is observing with close attention how the cannabis industry is being managed as well as how cannabis control measures are carried out throughout the country. Cannabis and cannabis products are produced for two different markets: medicinal or recreational. The medicinal market is aimed at patients with different illnesses such as, but not limited to, HIV, glaucoma, cancer, fibromyalgia and arthritis. On the other hand, the recreational market allows for the legal use of cannabis for personal consumption on a national basis. Canadians have access to cannabis that has been tested for quality and that can be trusted for its safety.
Cultivation and processing of cannabis in Canada must be undertaken following strict guidelines of Good Production Practices (GPPs). GPPs outline requirements for facility, security, process management, documents and inventory control. GPPs also require all cannabis and cannabis products to be analyzed for their microbiological and chemical content through the use of recognized and standardized pharmaceutical testing methods listed in one of the eight Pharmacopeia.
As Canadian cannabis companies become proficient within the evolving regulatory framework, they have turned their attention to national and international distribution and sales. In countries other than Canada, cannabis is often considered an Active Pharmaceutical Ingredient (API). APIs are manufactured following Good Manufacturing Practices (GMPs), whether from Canada or the United States of America (USP) or from European Union (EU GMP).
What are GMPs?
Good Manufacturing Practices (GMPs) are the core of quality assurance (QA) and management that ensures that pharmaceuticals are consistently and effectively produced and controlled to meet the necessary quality standards appropriate to their intended use. To achieve this assurance, GMPs apply to a set of topics including, but not limited to:
- Planning, conception and building of facility;
- Qualification of facility, equipment and materials;
- Validation of production processes and of production process as a whole via a Master Validation Plan;
- Documentation of employees’ qualifications;
- Training of employees;
- Planification of efficient facility cleaning (via a Cleaning Program);
- Clarification of expectations regarding employees’ behavior (via a Cleaning Program);
- Established procedures described in a QA system and presented by a QA Manual;
- Quality Control of product production;
- Controls to release only analyzed and safe products for sale;
- Follow-up of compliance and application of the QA system via an Audit Plan;
- Continual improvement of production via corrective and preventative actions; and
- Detailed record keeping.
Why should you comply with GMPs?
As the cannabis industry evolves, clients demand products of high quality and businesses must become more efficient to stay competitive and profitable. Following GMPs will assist your cannabis business to reach standardization and maximum yield.
GMPs are overseen by regulatory agencies in the United Kingdom, United States, Canada, Europe, China, India and other countries. Therefore, they provide international standards ensuring quality products are being produced by many industries, including the cannabis industry. Following GMP certification in Canada is an essential path to receiving EU GMP if you wish to export cannabis into another country. If you foresee reaching markets in Europe or Asia with your cannabis product(s), compliance to EU-GMP is mandatory.
What’s in it for you?
By becoming GMP compliant, you are telling investors, regulators and consumers:
- My company cares about end users.
- My products are consistent in quality.
- My products are produced in an environment that ensures safety and cleanliness.
- My products are manufactured according to written standards that are constantly monitored.
- My products are 100% traceable.
- My company is staying ahead of regulations – continuously improving, going above and beyond.
- My company is a legitimate business run according to best-in-class standards. We are to be taken seriously.
How can PipeDreemz help you achieve/maintain GMP compliance?
PipeDreemz Inc. has partnered with the international compliance software company, Isolocity Inc., to streamline the management of GMP requirements for the Canadian cannabis industry. Isolocity Inc. was formed to fill the gap in compliance management, reducing the amount of time and resources needed to reach compliance to quality standards such as GMP, ISO or even HACCP.
Moreover, PipeDreemz Inc. has GMP specialists currently consulting with Canadian cannabis companies and are available to assist you in achieving GMP or EU-GMP compliance for your company. Our professionals take great care in staying informed of current GMP practices and of the rapid regulatory changes related to the cannabis industry. PipeDreemz Inc.’s GMP experts can also assist in your preparation to obtain GMP certification awarded by a foreign auditor.PipeDreemz Inc.’s GMP professionals are at your service to help your cannabis company reach conformity and assist you with the following:
- Design and validation of building conformity to GMPs
- Assistance in redaction-review of key documents
- Quality Manual
- Verification of equipment conformity to GMPs
- Standard Operational Procedure update
- Master Validation Plan
- Verification of the flow of processes
- Approval of Standard Procedure for the cannabis industry
- Standard Operational Procedures writing
- Planification of Start-up activities
- Review of QA System
- Preventative Control Plan
- QA files organization and review
- Quality Control of documentation of activities
- Audit Plan
- QA coaching from experienced QAP from the Canadian cannabis industry
- Risk Assessment Evaluation
- Mock Audits
- Greenhouse Prevention Program
- GPPs Conformity Document
- CAPA efficiency evaluation
- Employee Training (regulations, QA system, etc.)
- Suggestion of corrective and preventative actions.
- Support for audit preparation
- Sanitation Manual
- Production Schedule Planning
- Inventory Management
Contact us to see how we can help you with your GMP requirements so that you are compliant.