Q: I understand the EU’s new Good Distribution Practices (GDP) for medicinal products require that an individual must be named as the primary responsible person for GDP compliance. Could you elaborate on this requirement?
A: The new EU GDP Guidelines — which went into effect in September 2013 — have adopted GMP principles and requirements to regulate medicinal products throughout all stages of the supply chain. The guidelines’ main focus is to maintain product quality and integrity by ensuring correct product storage conditions, particularly with regard to temperature, during storage and transportation.
As you’ve noted, the guidelines require the appointment of what’s called the “Responsible Person (RP)” to ensure GDP compliance. Note that this new role is not the same as the Qualified Person specified under other EU rules for manufacturing activities.
[pullquote align=”right” cite=”” link=”” color=”” class=”” size=””]The RP must be knowledgeable and experienced in Good Distribution Practices, and a degree in pharmacy is desirable.[/pullquote]
The RP must be knowledgeable and experienced in Good Distribution Practices, and a degree in pharmacy is desirable. The RP can delegate duties but not responsibilities. In addition, the RP should be “continuously contactable”.
Specifically, the EU expects the RP to:
- Ensure the quality management system is implemented and maintained
- Ensure the accuracy and quality of records
- Ensure training programs are implemented and maintained
- Coordinate and perform recalls as needed
- Ensure customer complaints are dealt with effectively
- Ensure that suppliers and customers are approved
- Approve GDP-related subcontracting activities
- Ensure self-inspections are performed
- Keep records of any delegated duties
- Decide on the final disposition of returned, rejected, or falsified products
- Approve any returns to sale-able stock
- Ensure any additional requirements of national laws are satisfied
To decide which links of your supply chain are required to have an RP, be sure to assess your entire supply chain, including temporary storage facilities at docks and airports, third-party transporters, and your use of brokers, internet suppliers, and sub-contractors.
Answered by Martin Browning, EduQuest President and Co-Founder (22 years as an FDA investigator and as the Special Assistant to FDA’s Associate Commissioner for Regulatory Affairs) and Dr. Kingsley Chesworth, Senior EduQuest Consultant and former Quality Assurance Director for two major U.K. pharmaceutical sites producing sterile and non-sterile products. Martin also was the Chairman of the U.S. Government’s ISO 9000 Committee and an FDA representative to the Global Harmonization Task Force.