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