The Quality Control controls, product and process validations, and the specifications applied throughout product development and manufacturing.
Additionally, 21 CFR Part 117, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food: Subpart B-Processes and Controls states that appropriate QC operations must be implemented to ensure food products are safe for consumption and food packing materials and components are safe and fit for purpose.
The objective of any laboratory seeking accreditation is to demonstrate they have an established QMS. Equally as critical, for product testing laboratories in particular, is the objective to establish GxP, “good practices”, to ensure test methods and laboratory operations verify product safety and quality.
Adherence to ISO/IEC 17025, and subsequently receiving accreditation, is an excellent way to ensure laboratories have put forth the effort to establish a QMS. However, for product testing laboratories specifically there are a number of “gaps” within the standard and the accreditation process.
There is no mention of requiring a root cause investigation, no requirement to document actions, and most importantly there is no requirement to document a retesting plan, including justification for retesting.
It is essential to provide cannabis testing laboratory owners and operators the proper guidance from the beginning and hold them up to the same rigor and scrutiny as other consumer product testing laboratories.
In her lead role at Triskele, Kathleen offers consultation services for GMP implementation, Standard Operating Procedure development, audit readiness, validation, and training to testing laboratories, cultivation facilities, and manufacturing facilities.
While at Merz, she was instrumental in achieving the successful build-out of a microbiological infrastructure which allowed for in- house testing of bioburden and endotoxin.
Kathleen is an executive member of the ASTM International Cannabis Standards Committee, D37.
On the other hand, the approach of the standard is metrological, in which the measurements as processes are controlled for assuring their validity contrasting them with the scientific, technical, industrial or legal values.
For five years now, we have been hosting this complimentary collection of webinar presentations, designed to help attendees better understand some of the more technical aspects of starting and operating a laboratory.
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