Five apparently equally respectable factories make the API you want… who do you go with?
You’ve checked the EDQM so you’ve found the sources with a CEP. You’re assuming – probably correctly – that all the basic Regulatory is going to be in place; they’ve got a GMP cert, a Written Confirmation and all the rest so they are a potential supplier.
You’ve found some contact details from the manufacturers’ websites, you are ready to send out your enquiries. Here’s how we take it from this point:
From our first email out we begin to judge the supplier. How long before they respond is the first consideration. Do you have to chase a second time? Do you have to call the switch board in order to find out who to send the email to, because no one is responding on the ‘sales@…’ email address?
What is quality of the response that comes… did they answer everything, or did you have to go back again? Did it all go ominously quiet when you asked a difficult question?
If you asked for documents, how long did you have to wait and how many chasers did you need to send? Does it feel like you are first person in the world to ever ask for a TSE statement?
The key conclusion that you are drawing from these initial communications is the willingness and interest of the manufacturer to service your enquiry and – without wishing to sound harsh – the personal capabilities of the individual you will have to deal with in future.
The preliminary round of replies will establish the pool of candidate suppliers and you rank by price as the most obvious factor but don’t let this be the sole criteria. The service requirement to get a new API source approved on a product licence is so high – through documentation, samples, validation, technical questions, possible QBD work, Technical Agreements etc – that there is a huge reliance on the individual at the other end of the email. Put simply you want to work with people who want to work with you… and it’s surprising how often it doesn’t feel like they do.
We can’t tell you what to do, but we can tell you our experience shows it is a remarkably accurate predictor of future problems if we are struggling from the first, most basic emails. If we are helping you choose a manufacturing source these intangibles will all be included in our assessment of the options and have a major influence on who we recommend.