GDP
GDP – European Commission Guidelines on Good Distribution Practice of Pharmaceutical Products
What is GDP standard?
According to the guidelines (GDP – EU 2013/C342/01- 05/11/2013) based on 2001/83/EC Directive, European Union sets out the compliance requirements for the wholesale and/or distribution of pharmaceutical products for human use (European Commission Guidelines on Good Distribution Practice of Pharmaceutical Products). Every organisation distributing pharmaceutical products is required to develop a Quality Management System and comply with the GDP requirements.
GDP benefits
- Ensuring and proving compliance with legal or other requirements
- Competitive advantage and increase in market share
- Building trust with customers
- More efficient handling of product recall cases and failures
- Enhanced staff training
- Reduction of risks from the handling of medicines during receipt, storage, distribution
- Less risks from handling of medicines upon receipt, storage and distribution
- Less complaints and effective complaint management
- Internal and external assessments help the organisation monitor its performance and continuously improve
Role of IDEC S.A.
- Assessment of current planning and infrastructure
- Consulting services to utilize organisational and improvement opportunities
- Development of required documentation
- Staff training
- Supervision of GDP requirements’ implementation
- Internal inspection of all procedures
- Certification procedure support
- Management system monitoring and support according to the current needs following the initial certification
- Scientific support on relevant legislation and regulations