Pharmacopoeias for Beginners
Im Auftrag der ECA Academy

US and European pharmacopoeias are independent organizations that set the standards for determining the quality of pharmaceutical products marketed in the US or Europe. These standards govern the quality, strength, purity and potency of active pharmaceutical ingredients, dosage forms and excipients as well as many reagents and solutions used to test these materials.

However, sometimes the pharmacopoeias differ in the quality requirements for the same product or raw material. Compliance, therefore, becomes a major challenge for pharmaceutical companies.

USP–NF standards deemed official by USP are enforceable by the U.S. Food and Drug Administration for medicines manufactured and marketed in the United States and they are recognized and used in more than 130 countries around the globe. The Ph. Eur. is legally binding in 38 European countries and used in over 100 countries worldwide. No wonder then that both pharmacopoeias are widely used by the pharmaceutical industry. Any pharmaceutical testing laboratory must be capable of applying the tests described in the compendial monographs.

In addition, pharmacopoeias are part of the regulations that QPs (Qualified Persons) must comply with for the release of the products as described in the registration dossiers. They also need to manage them in a more and more globalized environment. Therefore, visibility on the on-going drafts and/or work program could be useful for anticipation.