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GMP

Good Manufacturing Practice (GMP) Across The Global Cannabis Industry

Benefits Of Eating Cannabis
Written by Eran Yona
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Good Manufacturing Practices (GMPs) are manufacturing and administrative procedures and practices aimed to ensure that medicinal products, medical devices, food supplements and cosmetic products manufactured meet the required requirements, specifications and customer expectations in order to supply a safe and effective product to consumers…

GMP regulations include a variety of products such as human pharmaceutical products and veterinary products, biologically derived products, medical devices, packaging or food products. The principle of the regulations is that quality cannot be tested in the final product and /or in a specific batch or test, but rather be integrated in the entire manufacturing process, from raw material receiving and testing, until final product storage before distribution.

The GMP principles implementation and as part of that, receiving and in-process testing, in conjunction with other controls, monitoring and testing will enable to minimize the risks during production that cannot be eliminated by testing of final product only.

In the United States, the Food and Drug Administration (FDA) has issued these regulations as the minimum requirement for drug substances, drug products, medical devices, supplements and cosmetic products. Quality Assurance, production managers and senior management are responsible for ensuring that all procedures, practices, policies and SOPs are complying with cGMP guidelines.

Ten basic principles of GMP:

  • Proper design and construction of the facility, utilities and equipment
  • Proper Maintenance of utilities and equipment
  • Validation of facility, utilities, equipment, manufacturing processes, cleaning, testing methods and software
  • Write standard operating procedures and follow them
  • Document processes
  • Employees certification, development and training
  • Contamination protection and prevention
  • Employees health/hygiene
  • Quality built into the whole product lifecycle
  • Audits and inspections

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.

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.

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