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GLP (Good Laboratory Practice) regulations, crucial for generating medical cannabis sales, are international standards relevant for research, development and QC laboratories used for pre-clinical trials and studies, planned and performed

The studies being performed n a certified GLP laboratory should be monitored, recorded, then archived. The GLP regulations were published by the US Food and Drug Administration in 1976.

The quality aspects of GLP are defined by its capability to repeatedly provide the same testing and analysis service in the same specifications and levels. GLP includes the capability to protect the data integrity and quality of laboratory data. GLP Implementation is being performed based on written working procedures (SOP’s) and documentation of the work as it is being done.

The purpose of GLP is to support the development of quality and validated testing data used to verify the safety and compatibility to product specification. GLP regulation requirements cover several subjects, which include:

  • General requirements- Qualified personnel, adequate resources, Sanitation, employee health verification, garment, data storage
  • Facilities requirements-appropriate size, contamination separation, construction materials, sample storage
  • Equipment requirements- operational accessibility, efficiency, suitable for production rate, routinely maintained & calibrated, validation for equipment, validation for testing methods
  • SOP’s -Testing, sampling, data documentation, sample storage, equipment maintenance & calibration, labeling of samples and materials, protocol indicating test objectives & methods, final report of results, records retention, deviations investigations, out of specifications.

Without carefully following these regulations, no future is possible for the medical cannabis and CBD industry.

If you want to read the full original article, and get some more in-depth details regarding best practices for the cannabis industry, please CLICK HERE.

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Eran Yona has more than 20 years experience in the field of Biotechnology, most notably in the Medical and Pharmaceutical industries. Prior to founding Cannabis GxP and Bio-Chem in 2007, Eran worked in R&D in the field of genetically modified plant tissue culture, as well as a product development & technology Engineer, and Production & Operations Manager in several pharmaceutical and Agri-Bio companies. Six years ago, following Bio-Chem’s great success in consultancy and services for the Pharma and Medical industries, Eran decided to extend and expand Bio-Chem’s capabilities to the young but promising Cannabis industry. Eran and his dedicated team have lead many Cannabis companies to regulatory, technological, and financial success.

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