Pharmacopea compliance

TEMPLATES & PRESENTATIONS
1

Dear all,
I’m working in a company located in western europe. My company sells raw materials intented to be use in various biotechnology process, one of wich commonly used in Biopharma industry.

Regarding the sales of ours products to biopharma companies located in USA, I was wondering whether the fact our products are assesed to comply with european pharmacopoea indicators would be sufficiant enough to be accepted by non EU biopharma company?
In other words, does our company must comply with US pharmacopoea or the EU pharmacopoea compliance is relevant for US companies?

Thanks for any help you can give me.

Kind regards,

2

Hello,
If you sell your products in USA, your products must comply with USP, not EP.
Best Regards.

3

Thanks for your answer. I have had a discussion with colleagues, and one thinks it’s not as straightforward as that.
What are your thoughts about it? is there some flexibility from the biopharm manufacturing companies? why the quality of EP wouldn’t be recognize in US?
Many thanks for the discussion.

4

Because the USA has it’s own USP.
And another suggestion, don’t think, thinking isn’t comply with GMP rules.
Best Regards.

5

I agree with arzakan in all the comments.
When you are planning to sell your API to any country, if its required, you must be approved by the authorithies in that country.
That usually happen with US, EU or Japan.

6

Even though EU directives may be of high quality, there may be small things that are done differently in different places.

The way we handle eggs differently in the US always comes to mind.

7

Thanks all for your comments. It seems to be categoric, EP canno’t be accepted as a reference for US companies so.
We will look into the differences between USP and EP concerning our matter and see what additionnal costs it will brings.

8

Hi again,
As I was reading your comments again with my boss, he pointed my out the fact that I wasn’t explicit about the products we sells. Our raw materials aren’t API nor excipients. it is nutrients for fermentation as nitrogen and vitamins for micro organisms.
Our products aren’t even necessary to be GMP (even though we would) so perhaps the question about reliance with EP/USP is more relevant now ? I assume the differences are the reference methods wich are different.