Psyence Group Inc (CSE:PSYG), a life science biotechnology company pioneering the use of natural psychedelics in mental health, has revealed that its Psilocybin production facility has officially received International Organization for Standardization (ISO) 22000:2018 certification through the British Standards Institute (BSI).
ISO 22000 is a globally accepted international standard that specifies the requirements for food safety management systems.
Psyence’s facility, which is federally licensed to cultivate and export Psilocybin mushrooms for the legal medical and research markets, is based in Southern Africa and has been operational since January 2021.
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According to the company, the facility was built to ISO 14644-1 cleanroom specifications and engineering design principles. Moreover, the design allows various parts of the process to comply with Good Manufacturing Practice (GPM) standards required for product safety and quality to meet the certification needs of the BSI. The facility is equipped with calibrated specialised equipment to ensure optimum growing conditions and efficient harvesting and packaging, said the company.
Armed with the certification, Psyence is now “one step closer” to producing pharmaceutical-grade product for human clinical trials, including Psyence’s clinical trial in the field of palliative care and clinical trials run by research organizations.
In a statement, Psyence Chief Strategy Officer Tony Budden, who also heads up Psyence Production, acknowledged that the certification is an “important milestone” for the company.
“As a science-led company we are committed to producing high-quality, natural psilocybin,” said Budden, while adding that the ISO certification reassured the firm’s drug development partners and consumers, that its production processes meet globally recognized standards.
“The ISO 22000:2018 creates a single product safety standard that harmonizes the various national standards into one set of requirements that are globally accredited,” said Yasin Khan, who is the quality assurance manager at Psyence. “As part of the ISO 22000 process we had to conclude three successful and approved validation batches, all of which had to be audited. This is to ensure a consistent end-product in terms of safety and quality,” explained Khan.
The audits were finished in December 2021, allowing Psyence to achieve ISO 22000:2018 certification through the BSI, said the firm..
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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