Medicinal Cannabis GACP / GMP Training


(1) Introduction to regulations and compliance in the medicinal cannabis industry

This training will cover the specific requirements for the production of medicinal cannabis, including facility design, implementation of quality management systems (QMS), hygiene, what makes a batch, batch traceability, basic record keeping as per Good Documentation Practices (GDocP), quality risk management and Corrective and Preventive Actions (CAPA).  This course will also provide an overview of Good Agricultural and Collection Practices (GACP) and EU Good Manufacturing Practices (GMP).

  • Good Agricultural Practice GAP (pre-harvest)
    • EU Good Agricultural Practice – GAP guidance
    • WHO Good Agricultural & Collection Practice – GACP guidance
  • Part 1 – EU Good Manufacturing Practice (final dosage forms) and Part 2 – Good Manufacturing Practice (Active Pharmaceutical Ingredients)

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

During this training, we will also explore the following topics:

  • 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), will be used as reference throughout.

AUD $450.00 + 10% GST

Prices are per person and include morning tea, lunch and afternoon tea (excluded for Virtual Training).

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