Methodology
Reverse Thinking Cannabis

We assimilate our assessment as part of the regulatory review, technology and facility design outcomes.

Every project has it own unique challenges and surprises along the way. We try to minimize project “unknowns” prior to project initiation using advanced Risk Assessment tools that enable us to identify, assess, prioritize and mitigate mid and high priority risks that may cause budget, timelines and regulatory issues.

In our working methodology we combine “on-site” and remote working practices. We arrive to the client’s site during various essential points of the process, while using the best technologies available in order to support the project remotely, mostly in the documentation preparation stages.

Cannabis GXP is focused on value creation for our clients. Our main goal is to bring you from A to Z. At the end of the project, you and your team need to know everything we created in order to improve your in-house capabilities and to keep your business moving forward. This is the reason we enable our clients to be part of the project, based on their availability, to be involved in professional discussions, decision making, gaps closing in order to enable a smooth project handover etc.

We believe that in order to do it right, your team “has to understand”. At the end of every project we complete an intensive employees training program.

All project deliverables are documented, approved, and handed over to the client in an organized manner.

Every facility, utility, equipment, system and manufacturing technology that was purchased have to comply with GXP requirements and cost effectiveness principles. After installation, the process is fully qualified and validated in order to assure it meets clients processes requirements properly and in a constant and robust manner to maximize process capabilities and to achieve a full regulatory compliance. This is all in order to enable you to produce pharme-grade cannabis products that will give you premium branding and positioning in the global market.

In the pharmaceutical, medical and cannabis industries, every project end point is an external regulatory audit/inspection that should be completed successfully in order to have the marketing approval for your target market. As part of our project, we write and approve policies, procedures, protocols and engineering drawings as part of an effective quality and operation management system that will be inspected as part of the final audit.

After we have established the quality system and completed staff training, ensuring that all project gaps are closed, we conduct a “mock audit” in order to ensure the client in ready for the external audit.

Based on our GXP experience in quality and GXP audits, in most cases, we will escort the client in the external audit and offer our best efforts in order to achieve a professional approach in front of the auditor and to create the required communication in order to have a smooth site audit.

As part of our service, Cannabis GXP is committed to continuous improvement, business stabilization and support for the client after project completion and regulatory approval in all areas that our assistance and support are required. Based on our science-based orientation and location, we keep our clients updated and accessible to innovative products and new technologies constantly in order to expand the cannabis products pipeline if required.