With the growing use of medical marijuana, the legalization of marijuana for recreational use, and the increase in the production of industrial hemp, the need for cannabis-related quality assurance (QA) services is growing. Vitale Scientific Associates, LLC (VSA) is meeting that need by offering support services that are specifically designed for the cannabis industry.

Our services can help to provide for the most appropriate testing methodologies being applied in order to generate the most accurate and reliable data for this growing industry. Additionally, through the review of laboratory-generated data, VSA can assess the validity of results based on method requirements and regulatory standards.

Sampling and Analysis Program Development and Support Services

  • Laboratory management, inter-laboratory program management, analytical program design and management, sampling and analysis planning, and QA project planning needed to meet state, local and internal regulations.
    • Auditing and mock audits
    • Assessments
    • Training
  • Assistance with compliance to regulatory and voluntary standards and guidance: ISO17025, ASTM, AOAC,  FDA cGMP, GLP (US and OECD), GFSI, USP, ICH and FDA-BAM.
  • Analytical QA and quality control (QC), including working under all regulatory standards listed above.
  • Assistance to States in developing and implementing testing and QA programs for testing within these frameworks.
  • Assistance to manufacturers with setting up and troubleshooting QC sampling and testing programs.

Laboratory Program Oversight and Auditing

  • Laboratory facility planning, design and construction oversight.
  • Laboratory operational readiness reviews (ORRs) in preparation for state medical marijuana testing program requirements.
  • Management of laboratory procurements including drafting and issuing technical specification manuals; design, planning and execution of performance evaluation (PE) studies; and the evaluation of laboratory proposals.
  • Periodic, scheduled quality system reviews.
  • Establishment and assessment of laboratory records and documentation system.
  • Laboratory data review and data validation.
  • Verification of proper data management through data audits.
  • Coordination of blind and double-blind PE studies.
  • Supplier management and auditing.
  • Consultation and management of product quality/purity testing for regulated markets (e.g., state and local regulations).

Process Chemistry Services

  • Ensuring scientific data quality, so that chemical and physical data used to gauge the purity and stability of feedstocks, intermediates, catalysts, additives and final products, as well as the validity of required toxicity testing data, can be determined using the best-fitting sampling and analytical program available.
  • Analytical instrumentation expertise: TLC, HPLC, LC-MS/MS, GC, GC-MS, Headspace and SPME techniques.
  • High-resolution GC-MS, high-resolution LC-MS, NMR, Ion Chromatography, ELSD, ICP-OES, ICP-MS, CAD, qPCR, gamma spectroscopy, neutron activation analysis, flow-injection analysis, electrophoresis and commercial biochemical assays for microbial identification.
  • Experimental design, management, evaluation of laboratory studies for process chemistry and manufacturing process control.
  • Source identification and source allocation of mixed contaminants in products (e.g., chemical products, food, feeds, pharmaceuticals, etc.
  • Intellectual property (IP) support through the development of analytical characterization plans describing the necessary data needed to draft effective and comprehensive patent claims and enhance market exclusivity.

Analytical Methodology

  • Analytical method development and validation.
  • Chemical, microbiological and physical testing analytical experimental design, management and evaluation of laboratory studies involving medical marijuana products (MMPs), marijuana-infused products (MIPs), finished plant material, cannabis resin, cannabis concentrates, cannabis oils, environmental grow media, water sources and other materials.
  • Estimation of measurement uncertainty, statistical process control for marijuana cultivation including multivariate statistical analysis.
  • Experimental design, management, evaluation of laboratory studies in the cannabis industry for the following:
    • Cannabinoid Profile Testing for Major and Minor Cannabinoids
    • Terpenoid Profile Testing for Major and Minor Terpenoids
      • Monoterpenoids, Sesquiterpenoids, Diterpenoids and Flavonoids
    • Testing for Natural Contaminants and Adulterants
      • Pesticides, metals, residual solvents, microbes (bacteria and fungi) and growth enhancers
    • Testing for Degradation Products and Artifacts
      • Cannabicyclol- (CBL-) type phytocannabinoids, Cannabinodiol- (CBND-) type phytocannabinoids and other synthetic cannabinoid-like compounds
    • Analytical characterization of drug compounds and drug products.
    • Beyond-use dating (BUD).
    • Stability indicating method development and validation.
    • Stoichiometric API and counter-ion determinations.
    • Thermodynamic and kinetic solubility studies.
    • in-vitro and in-vivo quantitative determination of drug compounds and metabolites for pharmacokinetic and pharmacodynamics purposes.