Introduction to GDP

Description

Good Distribution Practices (GDP) is a quality system for warehouse and distribution centers dedicated for pharmaceutical & life sciences products. Internationally accepted pharmaceutical GDP regulations stipulate that distributors of pharmaceutical products must align their operations with the standards

All employees involved in the distribution of medicinal products need to be trained in order to comply with the requirements defined in the GDP guidelines.

Content

  1. The principles and objectives of GDP
  2. Legal framework : Directive 2001/83/EC
  3. Quality system
  4. Personnel
  5. Storage premise
  6. Operations
  7. Transportation
  8. Cold chain
  9. Complaints & recalls

Final skills

  1. Understand the basics of Good Distribution Practice for medicinal products,  the current legal regulations and guidelines;
  2. have the confidence to outline the main GDP requirements related to premises, equipment and personnel;
  3. get familiar with the principles of the GDP quality system and quality management, all the aspects of the transportation of medicinal products and the important procedures when dealing with complaints and recalls

Final knowledge

  1. The principles and objectives of the GDP
  2. The structure of a quality system
  3. The legal framework

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