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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

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