Pioneering the use of natural psychedelics in mental health and well-being, Life science specialist, Psyence Group, has announced that its ISO22000 graded Psilocybin production facility has officially received International Organization for Standardization (ISO) 22000:2018 certification.
Awarded 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.
We are reassured that our standard operating procedures are efficient and validated
The facility was designed and constructed to ISO 14644-1 cleanroom specifications and engineering design principles. This design allows various parts of the process to comply with the Good Manufacturing Practice (GMP) Standards required for product safety and quality in order to meet the certification needs of the BSI. The facility is equipped with validated and calibrated specialised equipment to ensure optimum growing conditions and efficient harvesting and packaging.
With this certification, Psyence is 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 organisations.
Tony Budden, Psyence Chief Strategy Officer, and Head of Psyence Production, said: "With this certification awarded by the BSI we are reassured that our equipment and processes are performing to the high standards required by the BSI, that our staff are skilled and experienced, and that our standard operating procedures are efficient and validated."
Quality Assurance Manager, Yasin Khan, explained that Psyence used the ISO 22000:2018 Quality Management system as the base for its BSI certification. "Set by the ISO, ISO 22000:2018 creates a single product safety standard that harmonises the various national standards into one set of requirements that are globally accredited," said Khan.
"As part of the ISO 22000 process we had to conclude three successful and approved validation batches, all of which had to be audited," Khan added. "This is to ensure a consistent end product in terms of safety and quality. The audits were concluded in December 2021 enabling Psyence to achieve ISO 22000:2018 certification through the BSI."