New EMA Inspection Requirements on Good Distribution Practices (GDP)

On 27 June 2013, the EU Commission updated the so-called "Compilation of Community Procedures on Inspections and Exchange of Information". This document serves the exchange of information and the harmonisation of inspection standards between all the EU Member States. Since July 2010, the document contains not only GMP but also GDP requirements.

The section "GDP Inspection Procedure" has been newly included. This had become necessary with the new requirements laid down in Directive 2001/83/EC according to which the competent authorties in Europe have to conduct inspections of wholesalers and brokers. The requirements which have been now formulated should harmonise GDP inspections in Europe. The structure of the provisions regarding the planning and performance of GDP inspections is very similar to that of GMP inspections. A GDP inspection should be carried out in each wholesaler or broker at least every 5 years. However, shorter inspection cycles should always be planned when required by the risk analysis. Elements that could influence the interval between inspections might include:

  • Size of site and number of staff
  • Number of customers / sales volume
  • Number of suppliers, type / category of supplier (i.e. special medicines)
  • Parallel import
  • Handling of specific products e.g. cold chain products
  • Number and relevance of previous issues, deficiencies, recalls and inspection deviations

During an inspection, the following documents should be particularly examined:

  • SOPs
  • Job descriptions and training of staff
  • Supplier assessments
  • Contracts regarding subcontracted services
  • System for handling a suspected falsified medicinal products
  • Deviations 
  • Suitability of premises

Ongoing activities and their documentation should also be examined like for example protocols of temperature and humidity monitoring, recordings of self-inspections, mock recalls, product quality complaints, product recalls.

The section of the issue and update of GDP certificates has also been added. This new provision will enter into force on 1st December 2013. The document contains a Compliance Statement which clearly shows whether a company has implemented the GDP requirements or doesn't comply with essential elements. The Community Compilation provides a template for a GDP inspection report. The deviations observed are classified according to the scheme (already known in the field of GMP): Critical, Major and Other Deficiency. The following examples show what falls under "Critical Deviations":

  • Purchase from or supply of medicinal products to a non-authorised person or company
  • Storage of products requiring refrigeration at ambient temperatures
  • Rejected or recalled products not separated and found in sellable stock

The newly released version of the Community Compilation not only requires the GDP certificates but also the GDP non-compliance statements to be included in the EudraGMDP database.

Source: Compilation of Community Procedures on Inspections and Exchange of Information

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