This course is based on FDA, Health Canada, and Articles 84 and 85a(3) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use and is a complete training solution for all individuals that need to acquire Good Distribution Practice knowledge.

Learning objectives

Upon completion of this online course trainees will:

  • be able to understand the basics of Good Distribution Practice for medicinal products for human use and the current legal regulations and guidelines;
  • have the confidence to outline the main GDP requirements related to premises, equipment and personnel;
  • 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

Course Content:

  • The principles of Good Distribution Practice;
  • The objectives of Good Distribution Practice;
  • Legal framework
  • GDP quality system principle;
  • Quality System Structure;
  • Quality Risk Management
  • Background and responsibilities of the Qualified person
  • Other GDP personnel;
  • Personnel training and hygiene
  • Premises - main principles;
  • Storage requirements;
  • Equipment
  • Control of documentation;
  • Quality System and procedures;
  • Recording and retention of documents
  • General prinicples;
  • Qualification of suppliers;
  • Qualification of customers;
  • Receipt of medicinal products;
  • Storage requirements;
  • Destruction of obsolete goods
  • General principles;
  • GDP Requirements in terms of transportation;
  • Containers, packaging and labelling;
  • Products requiring special conditions
  • General principles;
  • Returned medicinal products;
  • Falsified medicinal products;
  • Complaints and recalls