GACP/GMP Training – Cape Town

PICS-GMP-Training-Course-PE-009-13-1

GACP/GMP Training – Cape Town

Details Price Qty
GACP/GMP (Cape Town 20/02/20) R4,600.00 (ZAR)*  

* price includes taxes


  • GACP/GMP (Cape Town 20/02/20)
    20/02/2020
    9:00 am - 4:00 pm

GACP (Good Agricultural and Collection Practices) and PIC/S & 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)

Venue:  

Venue Phone: +27 21 448 6117

Venue Website:

Address:
Liesbeek Parkway, Observatory, Cape Town, South Africa