GACP/GMP Training – Sydney

GACP (Good Agricultural and Collection Practices) and EU GMP (Good Manufacturing Practices)

Introduction to regulations and compliance in the medicinal cannabis industry.

Discussion of quality management systems (QMS), including hygiene, what makes a batch, batch traceability, basic record keeping (Good Documentation Practices or GDocP), quality risk management and Corrective and Preventive Actions (CAPA)

• Good Agricultural Practice GAP (pre-harvest)
  • EU Good Agricultural Practice – GAP guidance
  • WHO Good Agricultural & Collection Practice – GACP guidance

• Part 1 – Good Manufacturing Practice (final dosage forms) and Part 2 – Good Manufacturing Practice (Active Pharmaceutical Ingredients)

Understand the common GMP requirements for both APIs and final dosage forms.

• • Global regulatory landscape
  • GMP main requirements including:
    • Pharmaceutical Quality System
    • Personnel requirements
    • Facilities and equipment
    • Documentation (Data Integrity)
    • Production
    • Quality control (inc. Trending and Out of Specifications (OOS)
    • Outsourced activities
    • Complaints and recalls
    • Internal audits

Annex 7 – Herbal medicinal products (flower products)