What is Validation in the Cannabis industry?

Validation is documented evidence with a high degree of assurance that demonstrates that any cannabis related system, facility, equipment, process, software, procedure or analytical method, comply with accepted criteria and requirements. The requirements are defined in a pre-approved validation protocol based on manufacturer specifications, customers process requirements, ‘Health Authorities’ regulatory requirements and Cannabis industry common practices.

Validation and qualification represent the effort to approve and assure reliability, quality, safety, and efficacy of the cannabis product.

Apart from the regulatory obligation, cannabis companies are subjected to a rationalized, robust and risk-based validation approach. This is implemented in the regulated Cannabis industry and can significantly decrease the quantities and costs of routine tests and analysis.

Why do we need validation in the Cannabis industry?

Since the 1960s, pharmaceutical drug products with pharmacological effects or impacts on human and animal health conditions are traceable by governmental health regulatory bodies such as the FDA. As a result, standards and guidelines were written and published in order to assure patient customer safety and health. Cannabis, either using its flowers or using Cannabis based products to treat medical conditions, is required to meet the same practices and methodologies that are common in the pharmaceutical industry, with the relevant changes.

Verification and validation procedures which will be aligned with FDA and European health authority’s requirements will improve product quality, safety, and efficacy and will meet consistency, repeatability and reliability standards.

What systems should be validated in the Cannabis industry?

Validation for Cannabis growers, manufacturers and distributors will include the following:  

  • Growing facilities- Climate, control, irrigation, fertilization, and lighting systems
  • Post-harvest facilities and equipment
  • Production facility- Clean rooms and control systems
  • Utilities- HVAC, control and monitoring system, water, compressed air, process gases, and steam
  • Manufacturing equipment
  • Manufacturing process
  • Sanitization and sterilization processes
  • Filling processes
  • Packaging and labeling processes
  • Software and computerized systems
  • Control and automation systems
  • Cleaning processes
  • Analytical system and equipment
  • Analytical methods
  • Storage areas
  • Supply chain

What validation protocols should be written for a cannabis facility?  

A validation project for a typical cannabis facility will include at least Validation Master Plan (VMP), Validation Plan (VP), Design Qualification (DQ), Installation Qualification, Operational Qualification (OQ), Performance Qualification (PQ), Computerized System Validation (CSV), Cleaning Validation (CV) and Process Performance Qualification (PPQ).

Apart from initial validation, the cannabis grower or manufacturer must ensure that the facility, equipment, systems, and processes are in a validated status over time. Therefore, re-validation and periodic re-qualification should be implemented.

About Cannabis GxP consultancy

Cannabis GXP is proud to stand at the forefront of the Cannabis industry in Israel and worldwide thanks to many years of experience in these areas.

Our team is compelled to spread the message of the importance of cannabis science, regulation and standardization as the world enters a new era of cannabis legislation.

We aim to position our clients with their best foot forward when it comes to anything and everything cannabis related.

Our vast expertise allows us to assist companies in a wide range of services and needs: Anything from Cannabis R&D, growing and manufacturing, new products development, facility design, technology, Quality Assurance, Good Practices (GAP/GMP/GLP/GDP/GCP), staff training, local and global regulations.

Cannabis GxP is a subsidiary company of Bio-Chem Ltd. (2007), a consultancy firm for the Pharmaceutical field, medical devices, Cosmetics and food supplements industry based in Israel.

Our cannabis consultancy services include:

  • Product development, delivery system & clinical trials
  • Growing, Manufacturing and Lab Facilities Design
  • Quality Assurance and Good Practices (GxP)
  • Cultivation & Product Manufacturing Technology
  • New product Regulations and Submissions
  • Qualification & Validation
  • Risk Assessment
  • Staff training

If you need one or several of our services, we will be more than happy to assist.

Please do not hesitate to contact us for further information.