- GACP/GMP (MEL 15/11/19)
9:00 am - 4:00 pm
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)
- Quality control (inc. Trending and Out of Specifications (OOS)
- Outsourced activities
- Complaints and recalls
- Internal audits
Annex 7 – Herbal medicinal products (flower products)
Venue Phone: +61 3 9878 4111
Venue Website: http://www.clariononcanterbury.com.au/Address:
Welcome to the Canterbury International Hotel
The Canterbury International Hotel is located in Melbourne’s south eastern suburbs only 20 minutes from the CBD and less than an hour from Melbourne airport.
This venue boasts 72 luxurious rooms for international and interstate attendees who require accommodation. Dining options include the on-site restaurant and relaxed atrium.
Wireless internet access is available.
Car-parking is available on-site.
City Information: Melbourne, Victoria
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