Should GMPs be Extended to Include Good Distribution Practices?
The European Federation of Pharmaceutical Industries and Associations (EFPIA), the trade organization representing European pharmaceutical manufacturers, is advocating a comprehensive strategy to address counterfeiting of drugs. Among its recommendations is a proposal to extend good manufacturing practices (GMPs) to include good distribution practices (GDPs).
EFPIA issued its recommendations in response to the public consultation launched in March by the European Commission’s proposed changes to European Union legislation.
“While basic regulations exist to prevent traders, brokers, or agents from causing safety problems, these need to be more strictly enforced,” said EFPIA in its response. “The current system of GMP (good manufacturing practices) should be extended to GDP (good distribution practice) audits as well as to the entire supply chain in order to assure that measures taken with respect to product protection, packaging practices, and distribution practices are properly used and followed.”
EFPIA’s proposal for GDPs is part of a larger strategy to address drug counterfeiting. This strategy includes requiring tamper-evident packaging on all products, use of overt and covert authentication features, strengthening product identification at an individual pack level through a harmonized coding standard, banning repackaging of drugs, and strengthening measures for liabilities and criminal penalties.
EFPIA’s recommendations come at a time when the problem of counterfeit drugs is escalating. In 2006, 2.7 million medicinal products were seized at EU customs borders, a 384% increase over 2006, according to EU statistics released by EFPIA.
The entry of counterfeit drugs brings with it the risk of substandard active ingredients and an obvious risk to patients. More stringent anticounterfeiting measures, including GDPs, are crucial for ensuring the integrity of the pharmaceutical supply chain. The EU’s effort to strengthen and harmonize EU standards should also serve as a basis for global harmonization efforts to address the weak links in the worldwide pharmaceutical supply chain.
Just curious but I do not recall seeing GDP as “good distribution practices” before this. Is this recent and/or EU acronym? GDP is “good document practices” term at certain places although don’t know of any usage in FDA guidance’s. Also more common use is as Gross Domestic Product in economics.
Back to article I do see that distribution is an area that may need more focused attention (even without counterfeiting concerns) as can be an after thought in the supply chain to some people on the manufacturing side (i.e. let someone else deal with). Although Wholesalers and Distribution Companies are generally well set up the shear volumes and variety of products (plus handling/storage issues) they deal with makes it difficult to maintain controls.
As part of the World Health Organization’s (WHO) Technical Report Series, Annex 5 of the WHO Expert Committee on Specifications for Pharmaceutical Preparations Fortieth Report (published in 2006) contains guidelines for good distribution practices. The report specifies that “good distribution practices are the part of quality assurance that ensures that the quality of a pharmaceutical product is maintained by means of adequate control of the numerous activities which occur throughout the distribution process.”
The issue of good distribution practices with respect to drug anticounterfeiting is further being examined by WHO’s International Medical Products AntiCountefeiting Task Force (IMPACT). IMPACT was formed in 2006 and is comprised of all 193 WHO Member States on a voluntary basis and includes international organizations, enforcement agencies, national drug regulatory authorities, customs and police organizations, non-governmental organizations, associations representing pharmaceutical manufacturers and wholesalers, health professionals and patients’ groups.
At the IMPACT general meeting held Dec. 13–14, 2007 in Lisbon,
a draft text proposing revisions to WHO’s Good Distribution Practices was endorsed. The IMPACT Secretariat submitted it to the WHO’s Expert Committee on Specifications for Pharmaceutical Preparations with a request for consideration, with feedback requested by
by June 2008.
In May 2008, EFPIA issued its recommendations to a public consultation issued by the European Commission on proposed changes to EU legislation to strengthen drug anticounterfeiting measures in Europe. As part of its recommendations, EFPIA suggested that a legal basis for “supply chain security inspections” be created in analogy to GMP audits, suggesting that WHO’s newly drafted “Good Distribution Practices” could be used and be supplemented by specific requirements for combating counterfeits.