GMP for Cannabis - What you need to know

Pre-Conference to the European GMP Conference

PROGRAMME

Welcome and Introduction

• GMP for Cannabis: setting the scene

 Dr Ingrid Walther, Consultant

Production of Cannabis flos for medical purpose

• Good Agricultural and Collection Practice, GACP
• Cannabis Production / Infrastructure / Monitoring
• Security Measures

Mag. Bernhard Föger, AGES

GMP Certification / Manufacturing and Importation Authorization

• Aspects to consider for applications for Manufacturing and Importation Authorizations
• GMP certification: What you need to know
• Inspections in Europe and beyond: Typical and recurrent compliance issues

Dr Reinhard Kerker, GMP Inspector

Narcotic drugs – The regulations

• Short overview of the German Narcotics Law ("Betäubungsmittelgesetz", BtMG)
• Necessary documents for granting general licenses and import / export authorizations by the Federal Opium Agency (BfArM)
• Reasons for refusal

Dirk Ohlenforst

Launch of Cannabis products

• Requirements to fulfil
• Infrastructure, global marketing and distribution agreements
• Medicinal cannabis products like oils and oil derivate products such as capsules, sublingual wafers and topical creams

Savvas Koulouridas, Fagron

GDP for Cannabis

• Requirements for transport to pharmacies, veterinary dispensaries, hospitals
• Requirements for distribution of cannabis through international distribution partners, wholesalers and 3PL partners

Silja du Mont, GDP/GCP Inspector

Supplier qualification and handling after import

• Facilities
• Packaging
• Release

Savvas Koulouridas, Fagron

Experiences - Lessons learned

• Application of GMP principles to Cannabis
• Quality management System (QMS) including Qualification/Validation
• DAB Monograph “Cannabis Flos”: Points to consider

Dr Ingrid Walther, Consultant