We identify key three elements: logistics know-how, regulatory expertise, connectivity
At the most basic level our job is moving drums of powder around the world – from the factory, possibly in the middle of nowhere, to the delivery time and place agreed with the customer. That can be a very long journey through to a timed 30 minute delivery slot in the UK.
This international trade requires a sound understanding of the movement of materials via the various trade routes and shipping methods; the documents and payment methods of international import/export trade; the transfer of risks and responsibilities, INCO terms, marine insurance, through to the correct type of pallet and stacking per individual customers’ requirements at point of delivery.
This may be ‘nuts and bolts’ stuff, but it’s of critical importance as without knowing how it all works we wouldn’t be able to move and supply anything.
But we’re also operating in a regulated industry and we are regulated ourselves, so not only must we know how to move our APIs efficiently we must know how to do it correctly . This means we must understand our customers’ regulatory requirements and – following the implementation of the 2015 EU guidelines on Good Distribution Practice for active substances for Human medicines - our own regulatory obligations.
Knowing – in advance – what regulatory documents our customers need from an API manufacturer means we pre-empt their requests and shorten the process for, eg, change control to approve a new source
So we can move stuff around the world and we know the rules… but this would all be for nothing if we didn’t know who to talk to.
Wessex was established in 1994 with the express aim of sourcing from the then nascent Indian API industry. A leap of faith in 1994 – so long before the internet and instant easy communications. As the world-wide, and especially Indian generic manufacturing base has grown, so we have kept pace.
However anyone who has tried to look for a manufacturing source for an API on Google knows that you might be through to page 25 of the results before you lose the will to live. There are commercial sourcing packages out there which collate public resources but do not answer all the questions.
You have to talk to everyone, you need a product and pipeline list from everyone and you need to manually put it into a data base so you can combine this with the other public access resources to identify potential sources. And then there’s no avoiding plain old hard work on the email and phone to find out who is in production and what their regulatory status is once you’ve established who the players are.
All three of the above elements are interdependent for successful API sourcing and distribution and the lack of any one means the overall package cannot function.