Medical Cannabis is fast becoming the new frontier
in modern medicine with TGO 93 marking the recent positive changes to the
Australian Legislative environment, providing quality standards for Medicinal
Cannabis and a pathway for researchers, doctors and pharmacists to begin the
development, manufacturing, prescription and distribution of medicinal
cannabis.
These new regulations have led to the emergence of
a number of cannabis-testing laboratories as well as massive facilities for
growing and manufacturing of medical-grade cannabis. Scaling of research and
evolution of regulatory requirements has resulted in a continuous growing
quantity of data, managing this data becomes quite a task. This is where the
implementation of a Laboratory Management and Information System (LIMS) can
make all the difference.
Key Features of a LIMS
for the Medicinal Cannabis Industry:
As the Medical Cannabis industry is new and rapidly
growing, the most important feature of a suitable LIMS must be that it is
flexible enough to readily adapt to changes in technology, testing and
regulatory requirements. Additionally, it must have the following features:
- Sample
Submission: Samples can be submitted either in person or via a Customer Portal, with barcode enabled Chain of Custody
(COC), storage location, possession and status tracking.
- Chain of Custody: Ability to track sample and aliquot information, from collection, transportation, testing, result entry through to disposal, along with ownership at every step of the lab workflow. Ensure the traceability of samples if sent to multiple locations for testing purposes.
- Quality
Assurance through Sample Testing and Analysis: Create qualitative and
quantitative tests for potency, terpene, microbial solvent, heavy metals and
pesticides. Record, track and generate the test results as well as record SOP’s
and ingredients to
ensure compliance with TGO 93 Standards
- Formulations & Raw Material Tracking: Create Product and intermediate product formulations, including a listing
of components and their quantities, as well as all the steps taken during
manufacturing
- Instrument
Integration and complete lab automation:
Interface the LIMS with your spectrometers and chromatographs either through an API or file-based integration
- Analytical (COA) and Regulatory Reporting: Create
intuitive and meaningful reports. Generate Certificates of Analysis (COA’s)
according to TGO93 requirements and authenticate test reports with e-signatures
- Data Security and Detailed Audit Trail: Role – based security and e-signatures restricts
unauthorised access to sensitive data complying with ISO 17025 and FDA’s CFR 21
Part 11
With the
present-day challenges faced by cannabis testing laboratories, implementing a
comprehensive LIMS becomes imperative. The goal of a LIMS is to ensure that your
lab is able to focus more on scientific research through the reduction of
manual workload, increased efficiency in resource management and ability to
comply with the changing regulatory environment.
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