About the course:
Standards of Good Distribution Practice (GDP) are applied to ensure that the high level of product quality achieved by observing Good Manufacturing Practice is maintained throughout the distribution network. The course covers management of all distribution chains from producers’ warehouses to pharmacies.
The course introduces European (Directive 2004/93/EC, 2001/83/EC, 2005/28/EC, 2002/98/EC and 2004/23/EC and Guideline 94/C 63/03), World Health Organisation, Canadian (Food and Drug Regulations, section C.02.015), US FDA (21 CFR 211.150, 21 CFR sections 203 and 205 and NDA/ANDA labelling requirements) legislation and guidelines.
Who should attend:
Personnel involved in storage, distribution and sales of pharmaceutical products.
Certificates of completion are given to course participants upon successful graduation.
Course program:
The course covers following topics:
- Legal GDP requirements put worldwide,
- Principles,
- Personnel,
- Documentation,
- Premises and Equipment,
- Deliveries to Customers,
- Returns,
- Self Inspection,
- Provision of information,
- Stability testing principles,
- Current topics on GDP.
Course Manual:
The course comes with a comprehensive manual, which proves to be an excellent handout and source of reference after the course.