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Good Review Practices (GRP) For The Medical Cannabis Industry

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Written by Eran Yona

GRP is documented in the Center for Drug Evaluation and Research (CDER) that describes the process, format, content and/or management of a product review. And that could include medical cannabis

GRP’s were developed as guidance’s for review staff or as manuals of policies and procedures (MAPPs). An example of GRP is MAPP 6010.3 Rev.1 Good Review Practice: Clinical Review Template. This is a standard clinical review template describing the format and content of a new drug application review. GRP policies are updated regularly as advances are being made in science, statutes update, regulations change, and accumulated experience are gathered.

GRPs are developed over time as superior practices based on CDER’s collective experience to provide consistency to the overall review process of new products. GRPs are developed to improve the quality of reviews and review management. GRPs improve efficiency, clarity, and transparency of the review process and review management. GRPs are expected to be adopted by review staff as standard processes through supervisor mentoring, implementation teams, and formal training when necessary.

GRP collaborates policies from various offices within the CDER which include
  • Review Management
  • Biometrics
  • Clinical
  • Clinical Pharmacology
  • Non Prescription‎ Products
  • Safety
  • Chemistry
  • Manufacturing
  • Pharmacology/Toxicology

GRPs fundamental values are quality, efficiency, clarity, transparency and consistency.

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.

[Image credit: Pixabay]

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About the author

Eran Yona

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.