January 22, 2024
Medication is, of course, intended to help people. So, we need to know the ingredients, such as the API, are safe to use. No matter where an API is produced, it has to meet the safety and quality criteria of the country where end users are located. That means drugs sold in the EU need to meet the strict safety and quality standards of the European Medicines Agency, and those sold in the US need to meet the regulations issued by the U.S. Food and Drug Administration (FDA).
Companies in the entire API supply chain get inspected by their local government. Foreign governments instances could also inspect them, and third-party companies do audits of each other companies.
When everything is up to code, companies are given a certain certificate, such as GMP or a written confirmation, so other professionals in the industry know that that specific company complies with the industry standards without them having to inspect or audit themselves. When the inspection fails, the companies will be issued a warning, and pharmaceutical buyers won’t be able to buy there until the issues are resolved and the company is re-inspected.
Not only the factory or production facility is inspected, but laboratories also analyze every batch of produced API; depending on the situation, it is even possible that one specific batch is analyzed multiple times: For example, by the company that produced it, by a 3rd party laboratory, by the trader who buys it, and by the hospital that will use it.
APIs are designed to interact with specific biological pathways to produce a therapeutic effect. For instance, the API in Aspirin, acetylsalicylic acid, works by inhibiting enzymes that produce pain-signaling molecules.
