“Not only is a Flexible Scope of accreditation not typical for traditional testing laboratories, it is very unusual for a CDMO such as Gemini to invest the time and resources to attain this level of testing competence,” said Mike Finamore, CEO of Gemini Pharmaceuticals.
According to the contract development and manufacturing organization (CDMO), laboratories accredited to ISO 17025 typically have a “fixed scope” of accredited testing. These individual ingredient tests are observed and approved by an accreditation body. This narrow list of analytical procedures defines the extent of a laboratory’s ISO 17025 testing accreditation, as each specific test is individually recognized and identified.
However, internationally there was a determination that select laboratories exhibit such high standards under the traditional ISO 17025 requirements that a distinction for this expertise was warranted. Therefore, the concept of a Flexible Scope was adapted, where only those laboratories with the highest standards can achieve flexibility in their ISO 17025 accredited testing.
To achieve the flexible scope status, Gemini’s in-house laboratory worked with the ANSI National Accreditation Board (ANAB) to demonstrate the required “exemplary standards and high quality of the testing performed by the laboratory”.
“Competence within this industry”
“We are very proud of our in-house laboratory’s achievement,” said Finamore. “The value-add of this accreditation is something we will share with our business partners to help grow their businesses with confidence.”
ANAB representative Chris Fox-Strauss, added: “We are pleased to recognize Gemini Pharmaceuticals Inc. as meeting the requirements of ANAB’s ISO 17025 non-forensic testing flexible scope policy. Gemini Pharmaceuticals has been a client of ANAB since 2020 and has demonstrated their competence within this industry”