Resources for Laboratories Seeking Accreditation for Psilocybin
Laboratories performing testing of psilocybin products must be accredited by ORELAP. Interested laboratories must submit a completed application, undergo an onsite inspection, and meet other applicable requirements as determined appropriate by ORELAP by rule.
News
ORELAP is now accepting applications for psilocybin testing. Please review the attachment directly below for more information.
Interested in joining an ORELAP psilocybin workgroup? Email us at
ORELAP.Info@odhsoha.oregon.gov to express your interest. There are four workgroups that meet on an as needed basis, they are:
- Potency Workgroup
- Speciation Workgroup
- Sampling Workgroup
- Proficiency Testing Workgroup
ORELAP held two information sessions on March 11 & 22, 2022 to provide information to laboratory stakeholders about psilocybin accreditation. Review the meeting materials below.
The Process
ORELAP accredits laboratories interested in compliance testing of psilocybin, cannabis, drinking water, and other environmental matrices. The process is similar no matter what type of testing the laboratory is considering. The process begins by registering for a username in our ORELAP Data Input and Edit (ODIE) system (a link to ODIE is located on the homepage). Once registered, the user can create an initial application for accreditation. The laboratory's application will be reviewed and invoiced in the order they are received. Once the invoice has been paid, ORELAP will arrange for an onsite assessment. The assessment will determine the laboratory's compliance to the accreditation rules and the 2016 TNI Standard. If the laboratory successfully completes and passes the onsite assessment, a certificate of accreditation will be awarded to the laboratory with an issued date and expiration date. The laboratory must renew its accreditation annually thereafter and will be subject to follow up onsite assessments every two years.
Tips for Success
Those unfamiliar with the ORELAP accreditation process will want to make sure they get up to speed now. Obtain a copy of the 2016 TNI Standard and become familiar with the requirements for accreditation. Make sure there are personnel at the laboratory who meet the educational and experience qualifications for the technical director and quality assurance officer. Assessments cannot be scheduled until invoices are paid and the laboratory has qualified personnel. Be prepared to show assessors method validation data (as described in the appropriate modules of the TNI Standard).
What Kinds of Tests?
ORELAP accredits
testing laboratories for potency (i.e., concentration) of psilocybin
products. The analytes for potency
testing include psilocybin and psilocin; we will not be accrediting laboratories for other tryptamines at this time. High Performance Liquid Chromatography (HPLC) is the most common technology for potency testing. Other technologies may be utilized but will need to comply with the 2016 TNI Standard requirements for method validation and performance. ORELAP
also accredits testing laboratories for speciation of
psilocybin fungi. Speciation testing is performed using a DNA-based approach, often using real-time polymerase chain reaction (qPCR) technology. The speciation method must be capabile of identifying Psilocybe cubensis. ORELAP also accredits laboratories for residual solvents testing of methanol and acetic acid. Finally, the sampling of psilocybin products is another ORELAP-accredited activity.