Excipients supply chain still needs tightening

By Gareth Macdonald

- Last updated on GMT

Related tags: Excipients, Pharmacology

Although there has been considerable industry effort to monitor and
control the distribution of pharmaceutical raw materials, the
voluntary nature of this regulation means that the supply network
is still susceptible to unscrupulous operators.

While drug regulators like the European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA) strictly control the safety of medications, they only issue guidance regarding the distribution of excipients. The onus is placed on drug firms to ensure excipients that find their way into finished products are safe and compliant with pharmacopoeial requirements. Ahead of her presentation at this year's ExcipientFest Europe, Linda Herzog, director of sales at US firm at Mutchler Pharmaceutical Ingredients, which supplies excipients to 18 of the top 20 US pharmaceutical firms, spoke with in-PharmaTechnologist about the current state of the global excipient pipeline. Herzog explained that there are three types of distributor within the excipient industry "those, like Mutchler, that receive and distribute containers that are sealed by the manufacturers and not opened until they reach end users in the pharmaceutical industry; those that open and repackage larger batches; and those that mix both practices."​ While trade associations such as the International Pharmaceutical Excipients Council (IPEC) have developed Good Distribution Practice (GDP) criteria with the blessing and support of bodies like the EMEA and FDA, there is no legal requirement for distributors to follow these guidelines, said Herzog. She went on to say that "while the vast majority of excipient distributors do their very best to ensure that they operate at the highest standards according to GDP guidelines, there are still those that do not understand the differing requirements of the pharmaceutical sector and wider industrial markets​." Herzog added that because distributors need to charge drug firms higher prices for excipients, due to the additional testing demanded by the industry, the sector can be attractive to unscrupulous suppliers that do not employ the safeguards necessary to ensure that the products they ship are fit for pharmaceutical use. Certification an option? ​ Herzog predicted that regulatory bodies worldwide would begin tightening up their regulation of the global excipient distribution network. She suggested that there is scope for a third party body to certify the practices of pharmaceutical excipient distributors. Herzog, who sits on the US IPEC committee involved in revising and updating the GDP guidelines, added that "the excipient industry needs to consider, for example, whether allowing excipients produced by different manufacturers, or indeed those made by a single manufacturer at different sites, should be mixed in the same batch."

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