Hallo,

Could someone, please, advise what should be done (validation, some part of validation) to implement the method for analyzing active pharmaceutical ingredient from European Pharmacopoeia. We buy the API, which is then used for production, we don’t make it.
Can you direct me to any guidelines, references etc. which deal with this subject.

P.S. What changes when the manufacturer has the official EP certificate for this product?

Hi,

EP methods are considered to be validated, according to EP officials, However, if you want to sell the product in other parts of the world, local regulations apply.

Hi,
In theory, the EP methods are validated but we use to check selectivity and limit of detection for the impurities.