Courses and Conferences on Good Distribution Practice (GDP)

Good Distribution Practice (GDP) is as important as Good Manufacturing Practice and has to be complied with by pharmaceutical companies but also by logistic providers and wholesalers. In 2013, the EU Commission published a new version of the GDP Guideline. The new GDP Guideline now contains a range of requirements which have to be correspondingly implemented and documented.

Requirements regarding the storage and transport of finished medicinal products have already been existing since 1994. Yet, the revision in 2013 brought considerable tightening. Furthermore, according to Chapter 2 of the GDP Guideline on Personnel a Responsible Person has to be appointed. Members of staff throughout the distribution chain (i.e. in warehouses, transport, and trade) as well as in pharmaceutical companies (logistics, supply chain) have to be sufficiently qualified and continuously trained.

In the course of the GDP implementation, written instructions about the implementation of the following sections of the GDP Guideline have to be provided:

• Quality Management
• Personnel
• Premises and Equipment
• Documentation
• Operations
• Complaints, Returns, Suspected Falsified Medicinal Products and Medicinal Product Recalls
• Outsourced Activities
• Self-Inspections
• Transport
• Specific Provisions for Brokers

In addition to the requirements for the transport and storage of finished medicinal products, GDP provisions must be established for the respective processes for APIs and excipients. These specifications for GDP are different from those for finished medicinal products.

Concept Heidelberg regularly organises conferences and courses on Good Distribution Practice, like for example:

• Responsible Person for GDP
• GMP meets GDP
• Cold Chain Management
• Courses and conferences on Good Distribution Practices can be found on the ECA website.