Axis medical provides consulting services on compliance with EU cGMP and cGACP (GACP certification is a prerequisite for the following mandatory EU cGMP certification when herbal medicinal products and APIs are produced) requirements. Our services are focused on Pharmaceutical Cannabis facilities which intend to attain an EU production license.

Evaluation and preparation

• Evaluation of the layout, processes, flows and cGACP-cGMP pharmaceutical cannabis compliance
• Development and sizing of a CONCEPTUAL design study and corresponding growing areas/green-houses layout
• Development and sizing of a CONCEPTUAL plan layout (floor plan) for the facility in order to ensure compliance with EU cGMP requirements.

Equipment selection

Technical assistance in the:

• Construction materials
• Greenhouse/Indoor design and climate control equipment
• Overview of cultivation equipment and materials
• Trimming, drying, grinding equipment, and post-harvest pre-processes overview and determination.
• Preparation of a full list of the typical production equipment (post-harvest process steps) and QC Laboratory equipment for ensuring compliance with EU cGMP

Personnel recruitment

• Preparation of a list of necessary personnel in accordance with the layout, the scale of the investment and the anticipated production capacity of the Contractor’s facility.
• Assistance in recruiting suitable production/processing and QC laboratory personnel according to EU cGMP and national pharmaceutical legislation.

cGACP and EU cGMP certification preparation

• Development of the GACP Management System
• Development of the EU cGMP Pharmaceutical Quality System
• Oversight and approval of the additionally required SOPs
• Training of all Contractor’s personnel with regard to the GACP Management System and the EU cGMP Pharmaceutical Quality System
• Evaluation of all IQ/OQ/PQ reports for the equipment installed, including evaluation of calibration certificates.
• Internal Audit of the GACP management system and GACP Application preparation and submission to the selected Certification Body.
• Internal Audit of the EU cGMP Pharmaceutical Quality System and Management Review preparation for the EU cGMP Pharmaceutical Quality System
• Oversight of the application file that will be submitted to the selected competent authority prior to the audit for acquiring the Manufacturing Authorization License and the EU cGMP Certification.