EU updates GDP in line with falsified medicines directive

The European Commission has published a new draft guideline on Good Distribution Practice for drugs, which brings it into line with the recently-adopted Directive on Falsified Medicines.

The new draft is up for public comment until December 31, 2011, and will replace and extend the existing regulations, which have been unchanged since 1994.

"The content of the Guidelines on GDP published in 1994 is no longer adequate," says the EC in its preamble to the draft, pointing out that they were drawn up before globalisation of the pharmaceutical industry injected much more complexity into the supply chain.

The new draft lays out comprehensive requirements for medicine wholesalers, focusing on: quality management; personnel; premises and equipment; documentation; operations; handling of complaints, returns, recalls and suspected counterfeits; contract operations; self-inspections; and transportation.

For the first time, the GDP guidelines also make specific reference to brokers, which do not operate premises or physically handle goods. Extended control over the active pharmaceutical ingredient (API) and medicines supply chain, including improved scrutiny of brokers and traders, was one of the key elements of the falsified medicines directive adopted in May.

"Brokers must maintain a quality management system that ensures applicable records are kept, efficient emergency plans for supporting recalls are in place and that competent authorities are immediately informed of any suspected falsified medicines offered in the supply chain," notes the guidance.

Other top-line changes from the earlier guidelines include much stronger emphasis on quality systems, including putting risk-management principles at the core of the operation, and specific guidance on outsourced activities both in the quality systems section and a separate, dedicated section on outsourcing.

New rules are laid out for transportation of products, including measures to protect against breakage, adulteration and theft. If a shipment is held in a warehouse for longer than 24 hours it is now deemed to be in storage and therefore required to obtain a wholesale distribution license.

Wholesalers should appoint a responsible person for each distribution site to ensure the quality system is implemented, and additional guidance is given on the requirements on responsibilities and training of other staff in the organisation.

Record-keeping requirements are beefed up over the prior version, with a commitment to retain documentation for five years and additional guidance on the use of computerised systems.

The issue of falsified medicines crops up throughout the document. For example, the section on operations notes: "the wholesale distributor should use all means available to ensure that the source of all arriving products is known to minimise the risk of falsified medicinal products entering the legal supply chain."

Wholesalers should have specific documentation in place to indicate how they will raise awareness among staff of the risk of falsified medicines entering the supply chain, and procedures for notifying competent authorities and the marketing authorisation holder of the genuine product.

Responsibility to verify medicines as genuine has been a bone of contention among wholesalers since the falsified medicine directive was adopted. 

Last month, the European Association of Pharmaceutical Full-Line Wholesalers (GIRP) issued a statement to the effect that verifying products received by checking the safety features on the outer packaging has "major practical implications."

"If individual pack scanning is involved it presents insurmountable challenges to the smooth operation of the distribution chain," said GIRP. The organisation would rather see selective testing of packs to avoid slowing down operations.

SecuringPharma asked GIRP for comment on the new GDP guidelines. The organisation's director general, Monika Derecque-Pois, said some of the provisions - particularly those in the transportation section - contain some "alarming" elements at first glance, although she stressed GIRP has not had time yet to fully analyse the proposals.

The group expects to issue an official response to the draft in the coming weeks.