Five issues to consider in API sourcing before they become a problem
API sourcing is a very complex process and there are many chances for things to go wrong.
In this article we look at some common issues which, if not understood and managed in advance, can turn into problems later: communication of known requirements and checking of manufacturer capabilities; the often neglected concept of ‘partnership’; some recent transportation issues and finally the importance of working with suppliers that want your business – and how to spot those that don’t.
In this world of internet shopping and next day deliveries ‘supply’ has become synonymous with ‘delivery’. We don’t have to concern ourselves about the process that leads to the delivery, just whether we will be in the house when the courier arrives with our new USB cable or t-shirt.
In great contrast, ‘supply’ of an active substance is a long complex process. It consists of many stages and we must accept that the final delivery of some drums of white powder is the last, very small, part of a whole package of technical, commercial, regulatory and service elements. Successful API procurement requires you to be aware which of those elements might affect your ability to receive your material. Risk mitigation is not an abstract concept here as we can often make choices earlier on to avoid problems later, and backtracking to fix an earlier bad decision can be expensive or even impossible.
A key realisation after many decades of raw material supply is that not every manufacturer is ‘right’ for every customer.
They make it; you need it... Voilà? No, it’s more nuanced than that, and we examine some of the issue ...