Hi, I am in the process of starting a DNA testing lab in Canada, but I’m unsure of the regulatory requirements for offering my testing services to other businesses in Canada. Specifically, I am interested in offering microbial identification services to GMP pharmaceutical companies. I have worked for a pharmaceutical company in the regulatory side of the business (QA) and in QC (microbiology) and I am well versed in GMP requirements for the pharmaceutical industry. However, I have very little knowledge of what is required of outsourced labs that process samples that they receive from GMP pharmaceutical companies. I assume accreditation is mandatory for outsourced testing labs. Is ISO 17025 the relevant accreditation? Is it possible to speak to you or send follow up questions to better understand the regulatory framework for a DNA testing lab in Canada?
I assume accreditation is mandatory for outsourced testing labs.
Typically, including outsourced testing, the required laboratory quality level is legally determined. For example, government departments such as immigration will only accept DNA test results for immigration and citizenship applications from laboratories accredited by a ILAC member accreditation body. Besides legal requirements, the benefit of accredition is that the competency of a laboratory is shown through their accreditation, so there is assurance in using an accredited laboratory for such tests.
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Is ISO 17025 the relevant accreditation?
Both ISO 17025 (testing and calibration) and ISO 15189 (medical pathology) are applicable quality standards for genetic testing while ISO 17025 is the relevant accreditation for an outsourced laboratory for testing for GMP (Good Manufacturing Practice). ISO 15189 is the accreditation required for diagnostic work on patient material. For certain clinical and preclinical analyses, the referral lab may need to comply / perform the study under OECD GLP, GCLP, ISO/IEC 17025, or ISO 15189 criteria.
The specific type of testing must be included under the scope of accreditation. For this reason, some laboratories will have both ISO 17025 and ISO 15189 accreditation as they perform general testing and diagnostic testing work. It is therefore important to clarify the needs of your clients.