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

See also