The transition from a local to global market in pharmaceutical excipients is increasing the risk of errors in the supply chain, with potentially serious public health consequences.
And it is remarkable that among the major public health problems associated with the use of substandard pharmaceutical excipients in recent years, the majority have come about not because of errors in manufacturing, but errors in distribution.
As supply chains for sourcing excipients become more complex, the likelihood of errors caused by mislabelling, contamination or substitution of one substance for another increases, potentially increasing the risk that patients can be put at risk from quality impaired products that could cause harm.
And with the European Commission’s pharmaceutical legislation placing the responsibility for the quality of medicines firmly in the hands of the pharmaceutical finished product manufacturer, drugmakers have a pressing need for increased traceability across the supply chain.
Recognising this, International Pharmaceutical Excipients Council (IPEC) Europe, together with the IPEC Americas, has drawn up a new Good Distribution Practices Guide, designed to help excipients distributors to ensure their quality assurance systems are effective.
It will also help pharmaceutical finished product manufacturers to qualify their distributors, and help manufacturers of excipients to ensure the safety and quality of their excipients throughout the supply chain, if they use distributors for sales and marketing of their products.
“Globalisation has led to more traders and distributors looking to buy excipients around the globe and sell into Europe to the final user. This was not the case 15 -20 years ago,” said Frank Milek, chairman of IPEC Europe’s GDP Committee, at an IPEC Europe seminar in Cannes, France, to launch the new guide to the industry body’s membership.
Milek notes that in 1998, the World Health Organisation issued a report saying that there had been 500 avoidable deaths in the previous 10 years caused by substandard excipients, including a notorious case in Haiti in 1996, when 88 people died from taking a cough syrup that was contaminated with poor quality glycerol. There is no telling how many other cases have gone unrecorded, he said.
“The guide gives real guidance to companies which are not familiar with GDP principles,” said Dr Milek. For example, a distributor of isopropyl alcohol will supply that chemical to not only the pharmaceutical industry, which may use it in wet granulation to make tablets, but also to the cleaning industry, coating companies, manufacturers of lubricants, etc.
“If the isopropyl alcohol is destined for a cleaning product it does not matter if it has 10 parts per million benzene – but this could be a huge problem if it ends up being used in tablet production,” he said.