28/29 September 2021
The Guidelines laid down in Article 84 of Directive 2001/83/EG on Good Distribution Practice (Document 94/C 63/03) haven't been changed since their first publication in the Official Journal of the EU in 1994. In view of the overall progress achieved in the practice of storage and distribution and, especially because of the new Directive 2011/62/EU on Falsified Medicines which is intended to provide Guidelines on Good Distribution Practice, a revision of the 1994 Guidelines was necessary.
On 15 July 2011, the EU Commission published on its website a draft guideline on Good Distribution Practice for public consultation. The deadline for comment is ending on 31 December 2011.
The revised guidelines are definitely more extensive. A catalogue of obligations for both medicines wholesalers and brokers is presented in 10 chapters.
Following regulations deviate from the Guideline 94/C 63/03 or have been newly created:
Chapter 1 - Quality Management
Extensive demands for a quality management system are expressed. Moreover, rules are presented regarding the management of outsourced activities, risk management and review through the senior management.
Chapter 2 - Personnel
This chapter deals with the duties and responsibilities of the responsible person and other key personnel. Besides, the chapter contains instructions regarding training and hygiene.
Chapter 3 - Premises and Equipment
The specifications regarding the use of materials are definitely more differential and include the handling with critical products like radioactive materials and flammable substances. Further topics in this chapter concern: temperature and environment control, equipment, computerised systems and qualification/validation. The last two topics have been completely missing in the guideline which is valid until now.
Chapter 4 - Documentation
While there were only 2 sentences in the Guideline 94/C 63/03, a whole page of the new draft is now dedicated to documentation. Among other things, the obligation for documents to be signed and retained for at least 5 years as well as the necessity of a SOP system are precisely described.
Chapter 5 - Operations
In this chapter, you will find more detailed instructions on supplier and customer qualification, storage, segregation and destruction of goods. The FIFO principle ("first in first out") has been replaced by the "FEFO" ("first expired first out") one which is nowadays the current storage principle anyway .
Chapter 6 - Complaints, Returns, Suspected Falsified Medicinal Products and Medicinal Product Recalls
A paragraph was already dedicated in the Guideline from 1994 to the distributor's obligations in case of discovery of falsified medicines. What is new in the revised guideline is that the distributor is obliged to "inform his personnel about the risks of falsified medicines penetrating the supply chain" which in other words mean that the personnel must receive adequate training.
Chapter 7 - Contract Operations
This is a new topic which hadn't been dealt with in the older guideline.
Chapter 8 - Self-Inspections
The introduction of a self-inspection programme is now required. A new feature is that audits - in the context of this programme - can also be performed by an independent third party organisation.
Chapter 9 - Transportation
This chapter contains very detailed instructions and some improvements. For example goods can't be stored longer than 24 hours in a distribution centre. If there is no transportation after this time limit, the premises will be deemed to be acting as a storage site and required to obtain a wholesalers distribution authorisation.
Chapter 10 - Specific Provisions for Brokers
Brokers haven't been addressed yet. The new draft contains clarification regarding the broker's activities. Brokers are not subject to premises regulations since they don't physically handle the goods they buy and sell. Nevertheless, they must have a quality management system and are responsible for adequate training of their personnel - regarding the question of falsified medicines too. This chapter also contains a list of SOPs which a distributor has to comply with.
The requirements described in the new GDP Guideline are extensive and are partly much more detailed than the general formulated regulations for wholesalers which are valid for the time being. Above all they are a consequence of the requirements of the new Directive on Falsified Medicines.
Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)