2020-08-06T18:04:46+00:00December 23rd, 2018|

Performing a Scientific and Systematic Risk Survey includes listing manufacturing processes in which potential hazards exist while describing the corrective and preventive actions for these risks.

  • Perform hazard analysis.
  • Find and identify the critical control points (CCP).
  • Set boundaries (establish critical limits) for the critical control points, and determine the range beyond which the product will be considered unsafe.
  • Determine and create monitoring measures for the control points and define them in work procedures and production instructions based on the limits defined at the identified critical control points.
  • Decide on corrective actions to be taken if deviations from the critical limits occur.
  • Verify and record (document) all actions, taken at all stages, of the process and controls.
  • Write, approve and provide guidance on procedures to verify that the various systems and processes are working as required and are effective.

Product Development, Delivery System & Clinical Trials

Novel cannabis products and delivery system for improved bio-availability, accuracy, consistency and efficacy that can be proven and backed up with a strong IP and clinical trials

Growing, Manufacturing & Lab Facilities Design

Conceptual & detailed design including personnel/material flow diagram, pressure cascade, cleanness level, utilities and technology based on current GxP standards and common practices

Quality Assurance & Good Practices (GxP)

An effective quality management system establishment, policies and SOPs writing, cultivation and manufacturing procedures, protocols and employees training

Cultivation & Product Manufacturing Technology

Utilities, systems, machinery and controls required for cultivation, development and manufacturing processes that will enable high quality, control and cost-effectiveness.

New Product Regulations & Submissions

Cannabis products specifications and regulatory requirements completion including all relevant documentation and data in order to be submitted and sold in regulatory markets

Qualification &Validation

New facility, infrastructure, utilities, system, machinery, software, control system, manufacturing/cleaning processes qualification and validation protocols, execution and reports

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