The European Commission's Directorate General for Health and Consumer Policy (DG SANCO) published the draft of the revised 'Guideline on Good Distribution Practice of Medicinal Products for Human Use' for public consultation. The European Medicines Agency through its GMP/GDP Inspectors Working Group worked on the revision of the guideline which was first published in 1994.
The guideline was revised to take into account advancements of practices for an appropriate storage and distribution of medicinal products in the European Union. Moreover, it should take into account the amendments to the Community Code which have been introduced with Directive 2011/62/EU of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products.
With the new guideline, a quality management system would be introduced for wholesalers, which also includes quality risk management principles. "Wholesale distributors must maintain a quality system setting out responsibilities, processes and risk management measures in relation to their activities." Senior Management should be responsible to support all parts the quality system with adequate resources, premises, equipment and facilities, whereas the Responsible Person should be responsible for implementation and maintenance of the quality system.
The system should also include change control requirements, the control and review of any outsourced activities and a formal process for reviewing the quality management system on a periodic basis (Management Review).
In Chapter 2 "Personnel" qualification, tasks and responsibilities of the Responsible Person are defined. This Responsible Person should be permanently available. General requirements like organisational chart, job descriptions and training requirements are new or outlined in much more detail. The practical effectiveness of training should then be periodically assessed and documented.
Requirements have been set for products with specific handling instructions (e.g. narcotics), radioactive materials and other hazardous products, as well as products presenting special risks of fire or explosion.
Also a temperature mapping requirement is now part of the draft guideline. After an initial mapping, it should take into account seasonal variations. If refrigerated vehicles are used, a temperature mapping needs to be performed at least once a year here as well.
Two other new parts are focussing on equipment and computerised systems. All equipment should be designed, located, maintained and calibrated in a suitable manner and computers must be qualified at least to the minimum requirements defined in the new guideline. Any qualification and validation work should be performed based on a risk assessment approach.
Qualification of suppliers and customers: all suppliers need to be qualified in an adequate way, meaning for example that wholesale distributors must verify compliance of another supplying wholesale distributor with the principles and guidelines of GDP. And where the medicinal product is obtained from the manufacturer, wholesale distributors must verify that the manufacturer or importer holds a manufacturing authorisation. It is important that the qualification should be performed prior to any procurement. The selection, including qualification and approval of suppliers should be defined in SOPs and the results should be documented and periodically evaluated. Wholesalers must also ensure that they supply medicinal products only to persons or legal entities who are in possession of a distribution authorisation or who are authorised or entitled to supply medicinal products to the public. This is not new, but this qualification of customers should be appropriately documented and re-checked including requesting copies of customer's authorisations and evidence of qualifications or entitlement according to national legislation. When it comes to outsourcing activities (like for example transport activities), written contracts need to be established, covering all distribution activities and clearly establishing the duties and responsibilities of each party.
FEFO instead of FIFO. The current Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03) requires a system to ensure stock rotation ("first in first out"), whereas the new draft calls for a picking on a "first expired first out" (FEFO) basis.
In the new draft, recall procedures are covered in a dedicated chapter on "Complaints, Returns, suspected falsified Medicinal Products and Medicinal Product Recalls", describing in detail the respective expectations. Very important is the fact that the national competent authority would have to be informed "without delay" about any complaint concerning a potential product defect or a potential falsified product - and also, where applicable, the marketing authorisation holder of the respective medicinal product. A system of mock recalls has now been integrated in the new draft as well: "The effectiveness of the arrangements for recalls should be evaluated regularly".
Transportation and training of drivers: the new draft emphasises the responsibility of the distributor to ensure that vehicles (and equipment) used to distribute and transport are suitable for their use and do not affect quality and packaging integrity. The drivers (including contract drivers) should be trained in the relevant areas of GDP.
Other proposed requirements are:
"There should be procedures in place for the operation and maintenance of all vehicles and equipment involved in the distribution process"
- "Deliveries should be made directly to the address stated on the delivery note and must be handed into the care of the consignee"
- "Where transportation hubs are utilised in the supply chain, a maximum time limit of normally 24 hours should be set to await the next stage of the transportation route"
- "For refrigerated product any storage at a transportation hub for any period of time would require that premises to hold a wholesalers distribution authorisation"
- "In the event that the transportation of medicinal products requires unloading and reloading e.g. at terminals and hubs, these premises should be audited and approved"
- "Validated temperature-control systems (e.g. thermal packaging, temperature-controlled containers, and refrigerated vehicles) should be used to ensure correct transport conditions are maintained between the distributor and customer"
- "The process for delivery of sensitive products and control of seasonal temperature variations should be described in a written procedure"
Chapter 10 then describes specific provisions for brokers, who also need to have a quality system and trained personnel.
The draft guideline is of particular interest to wholesale distributors and brokers of medicinal products for human use as well as for manufacturers who distribute their own products. Some of these new proposals might raise the need for further discussion. Comments and suggestions are invited by 31 December 2011 and should be sent by email to: SANCOemail@example.com and ADM-GMDP@ema.europa.eu using this template for comments.
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)
EMA press release
Revised Guideline on Good Distribution Practice of Medicinal Products for Human Use
Current Guideline on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03)