Dr Joachim Erler, Auditor / QP, Blue Inspection Body, Germany
Luis Meirinhos Soares, GMP / GACP Inspector, Infarmed, Portugal, Member of the ECA Cannabis Working Group
Angela Müller, Senior Regulatory & Scientific Affairs Manager, Dr. Willmar Schwabe, Germany
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13.30 – 13.45 h Welcome and Introduction
13.45 – 14.45 h
The Intersection between GACP and GMP - View on the Inspection of Cannabis GACP and its Relation to GMP
- When does GACP end and (EU) GMP start?
- What will be checked during GACP and EU GMP inspections?
- Observations in inspections
- Open questions and issues to be solved
14.45 – 15.00 h Time for Discussion
15.00 – 15.15 h Coffee Break
15.15 – 16.00 h
GACP – Regulatory Information
- Herbal Drugs
- GACP vs. GMP
- Information in the Dossier
- Grower and Supplier
- Geographical source
- Herbal substance Manufacturing
16.00 – 16.30 h
GACP – Auditor´s View
- Cannabis Cultivation
- SOPs & records
- Expectations of a GACP auditor
16.30 – 16.45 h Time for additional Questions and Discussion
16.45 – 17.00 h Break
17.00 – 17.30 h
GACP – Grower´s / Supplier´s View
17.30 – 18.00 h Final Discussion