Siegfried Schmitt discusses the European Commission's (EC) guidelines on Good Distribution Practice of Medicinal Products for Human Use, published March 7, 2013 (2013/C 68/01). This document replaces the previous version from 1994. This new GDP guideline applies not only to the wholesalers and manufacturers of pharmaceuticals, but also brokers. The guideline comes into force on September 8, 2013.
Q. Are there any significant new requirements in the EC's guideline?
A. Unfortunately no, unless the broker also has a permanent address in an EU Member State and is registered there.
Q. What are the key changes for wholesalers?
A. The role of the responsible person has been defined in much more detail. This is a role comparable to the head of the quality unit. The regulation specifies that the responsible person should fulfill their responsibilities personally and should be continuously contactable. The responsible person is only allowed to delegate duties, but not responsibilities. Moreover, this expert should have a degree in pharmacy. No explanation is given for this peculiar expectation, nor is it made clear what acceptable alternatives may be. Few companies employ a pharmacist as wholesale and distribution is not a classical field of expertise for pharmacists.
Q. Have there been any significant changes affecting warehouses?
A. Yes, with regards to storage and segregation, and computerized systems. The standard requirements for restricted access and segregated areas for medicinal products can still be complied with through physical segregation or by means of a validated computerized system. However, medicinal products received from a third country, but not intended for the EU market, have to be physically segregated. The same requirement for physical segregation now also applies to expired products.
A computerized system needs to be validated or its fitness for purpose demonstrated through verification studies. What constitutes appropriate verification studies though remains a total mystery. It is accepted practice that quality relevant records need to be retained for certain periods of time. Why the authors of this guideline decided to codify that backup data (but, not the records) are to be retained for a minimum of five years at a separate and secure location is another unexplained mystery. Backups are generally kept for a week by which time they have become obsolete.
Q. Despite all the above, the guideline surely strengthens compliance and strengthens supply-chain security?
A. Without a doubt, the guideline has been long overdue and is welcomed by industry and regulators alike. Requiring wholesalers and brokers to be licensed or registered, and to also have a comprehensive quality system in place, is a great step forward. It is not yet clear to what extent these companies will be in a state of compliance by September, if the Member States will have the necessary administrative processes in place (e.g., for broker inspections and registration), and if these tightened regulations may lead to certain drug shortages. The pharmaceutical industry will also have to amend their procedures, as they must assure that in future they will only use appropriately licenced/registered and compliant wholesalers and brokers. As with all new regulations, teething problems may be expected, but overall it will strengthen supply-chain security and patient safety.