RE:Eugmp Update on MD&A posted on Sedar Niagara Facility
During the three months ended December 31, 2020 (“Q4 2020”), the Company completed an inspection with certified auditors, who deemed the facility to be operating as European Union Good Agricultural Practices (“EU GACP”) compliant. This allows flower grown at the Niagara Greenhouse to be exported to certain international markets including the European Union, after it has been dried and packaged in an EU-GMP certified facility. Production lots which are destined for international sale are grown under specific EU GACP standard operation procedures, with first harvests of flower grown under these conditions completed subsequent to the reporting period.
European Union
During Q4 2020, the Company completed an inspection with certified auditors which deemed the facility to be operating as EU GACP compliant. This allows flower grown at the Niagara Greenhouse to be exported to certain international markets including the European Union, after it has been dried and packaged in an EU-GMP certified facility, and following receipt of necessary import and export permits for each shipment.
Subsequent to the reporting period, the Company sent three batches to Germany of its greenhouse flower for stability, quality and cannabinoid testing. All three lots were deemed to meet EU GMP standards. With the successful testing results, the cultivar specific dried flower grown at the Niagara Facility is eligible to be exported to the EU market, pending receipt of necessary import and export permits. The Company’s strategic export partner, which owns and operates an EU-GMP certified facility, has applied for the necessary import and export permits, which represent the final stage in completing the Company’s first shipments of cannabis to the European Union.
Twizzle wrote:
Paris Facility
The Paris Facility (the “Paris Facility”) features cultivation rooms and handles all extraction, finished goods manufacturing and packaging for the Company’s medical, adult-use and international sales. The indoor cultivation at the Paris Facility is primarily used for premium dried flower products.
The expansion of the Paris Facility (“Paris Phase II”), licensed in Q2 2020, is entirely dedicated to the extraction, production and packaging of high-margin, value-added cannabis health and wellness products. The expansion allows the Company to process and package all flower cultivated at its Port Perry Facility (the “Port Perry Facility”) outdoor cultivation site and its Niagara Facility (the “Niagara Facility”). The Paris Phase II expansion increased the Company’s licensed extraction, packaging and processing area from 2,500 sq. ft. to 20,000 sq. ft. It features multiple automated packaging lines and rooms dedicated to the production of new product formats, along with in-house quality control analytical testing. Currently, the Company’s machinery at the Paris Facility allows for annualized extraction of 50,000 kgs of dried cannabis flower and is capable of extracting 115,000 kgs at full capacity, as needed.
The expansion is purpose-built to meet European Union Good Manufacturing Practices (“EU-GMP”), which represents the highest standard of pharmaceutical-grade production in the world. As a result the certification would provide the greatest possible access to global markets. As previously announced in May 2020, the Company’s indirect subsidiary, Aleafia Germany GmbH, submitted its application to German regulators for EU- GMP certification.
As part of the certification process, an in-person inspection from Germany-based regulatory authorities is required and had been previously scheduled for December 2020. To prepare for the inspection date, the Company began gradually implementing EU-GMP compliant processes for the manufacture of oil drop products (extracts), and the Paris Facility is now operating in an EU-GMP compliant manner. However, due to COVID-19 related travel restrictions, the Company cannot provide a timeline for an in-person inspection.