2020-08-04T17:45:58+00:00December 27th, 2018|

Validation is well-documented proof with a high level of confidence that a system, equipment, software, test method, drug manufacturing, sterilization or cleaning process will be consistently and robustly delivered, providing a result that meets the requirements of predefined specifications in approved validation protocols.
The purpose of the validation process  is to ensure that a pharmaceutical product meets all quality, efficacy and safety requirements that have been set for the final product, during all stages of production and in different batches of the same product, while adhering to a controlled and documented process.

Validation processes includes a validation plan (VP), risk assessment, system design or design qualification (DQ), installation qualification (IQ), operational qualification (OQ), system performance qualification (PQ), production process qualification (PPQ), and validation of cleaning processes, software and control systems and repeat/periodic validation.

To the article What is validation? Why should validation be done? Who is committed to performing validation? What are the types of validation?

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

Let’s Change the Game


Subscribe to our cool newsletter.