The March 2013 EU Guidelines on GDP: More Questions than Answers?

A couple of weeks ago the European Compliance Academy's GMP News posted an article that poses some interesting questions about the newly published EU Good Distribution Practice Guideline published in the official Journal of the European Union (Download the PDF). In this week's blog, we summarize and comment on some of the changes to distribution practice that come into effect with this new guidance.

On March 7, 2013, the European Commission finalized and published the new Good Distribution Practice (GDP) guideline thereby updating the 1994 document, The new guidance incorporates the requirements of the EU Falsified Medicines Directive from 2011. Key changes address the growing risks of counterfeiting and worldwide pharmaceutical distribution. These guidelines apply not only to manufacturers but also to wholesalers, brokers, resellers, transportation companies and logistics suppliers.

As of September 8, 2013, the new GDP guidelines are in force, so whether you are operating within the EU or planning to transport product there, understanding the changes to practice will not only help your organization comply, but will help safeguard the supply chain from fraudulent, possibly harmful products.

Four changes to the guidelines that may impact your business include:

 

Quality Management System (QMS)

To ensure that your Quality Management System (QMS) is aligned with the new guidelines you will need to implement the quality systems model outlined in ICH Q10 "Pharmaceutical Quality System", which exemplifies a pharmaceutical quality system throughout the product lifecycle. The original goal of Q10 was to emphasize a scientific approach to the Pharmaceutical Quality system and integrate that approach over the entire supply chain. Recall that the parts of ICH Q10 that go beyond the scope of current GMP are optional, however, the new GDP document further validates the ICH Q10 guidelines making those points that are extraneous to the requirements of cGMP at least a notch closer to becoming an industry expectation.

Additionally, the new GDP guidance focuses on a complete lifecycle approach to quality management that is properly planned and resourced according to ICH Q9 "Quality Risk Management." This includes regularly planned reviews and corrective/preventive action plans if needed, as well as defined processes for deviations and audit results.

The Responsible Person (RP)

From the new GDP guideline:
"The wholesale distributor must designate a person as Responsible Person. The Responsible Person should meet the qualifications and all conditions provided for by the legislation of the Member State concerned... A degree in pharmacy is desirable. The Responsible Person should have appropriate competence and experience as well as knowledge of and training in GDP. The Responsible Person should fulfill their responsibilities personally and should be continuously contactable. The Responsible Person may delegate duties but not responsibilities."

While the new guideline clearly defines what the responsibilities are, it is not so clear in the following areas:

• What are the RP’s minimum qualifications?
• Can the RP be a contractor?
• Must a single RP be available 24x7 or can there be multiple RPs?
• Is the RP directly responsible for customer complaints, recalls, qualification and approval of suppliers, training plans, training to identify falsified medicines, continuous improvement and reporting or oversight of all of the above?

It must be noted that despite these unanswered questions, designating a person to be responsible for meeting the elements of GDP is now a requirement along the entire supply for manufacturers, wholesalers, and logistics suppliers.

Transportation Hub

"Where the transportation route includes unloading and reloading or transit storage at a transportation hub, particular attention should be paid to temperature monitoring, cleanliness and the security of any intermediate storage facilities. Provision should be made to minimize the duration of temporary storage while awaiting the next stage of the transportation route."

This part of the new guideline emphasizes temporary storage. It tightens the requirements in an area that can often be at risk for non-compliance. However, as in the guideline on designating a Responsible Person, there are some unanswered questions, many of which will depend upon variables such as the specifications of the product being shipped, the length of transit duration, the number of transit hubs, the role of each supplier in the chain, etc. Key questions include:

• How long can I store product?
• Do I have to validate the facility?
• Is my hub subject to an audit?
• Do I need continuous monitoring or data loggers
• Is this data required for an audit?
• As a wholesaler, am I responsible for the transportation provider’s compliance?

With implementation taking place over the next several months to make the September deadline, stakeholders throughout the medicinal product supply chain will be following updates from the European Commission as organizations come forward with these questions and more.

 

Risk Assessment

“Risk assessment of delivery routes should be used to determine where temperature controls are required. Equipment used for temperature monitoring during transport within vehicles and/or container should be maintained and calibrated at regular intervals at least once a year…"

While the new guideline is very clear in most areas, there are other areas that sorely need some clarification as cold chain suppliers and stakeholders seek to comply by September. The European Compliance Agency(ECA) has set up a Working Group to address these concerns with a plan to produce an Implementation Guideline. Follow the European Compliance Agency’s website to stay abreast of communications from the Working Group. www.gmp-compliance.org/eca

Source: "Final GDP Guideline published by EU Commission" published 12/03/2013 in GMP News. Read complete article here.