API Manufacturing: Complying with International GMP Regulations

Asian Manufacturers of Active Pharmaceutical Ingredients (API) have to adhere to Good Manufacturing Practice (GMP) guidelines in order to penetrate Western markets. The majority of medicinal products manufactured in Europe and the US contain Active Pharmaceutical Ingredients (APIs) and excipients which have been manufactured in Asia. In recent years, these active and inactive pharmaceutical ingredients […]

Auditing / Qualification of Active Pharmaceutical Ingredient Manufacturers by Accredited Inspection Bodies

Active ingredients for the production of medicinal products have to be manufactured according to the principles of good manufacturing practice (GMP). The licence holder has to verify this on site. As only few active ingredients are produced in Europe today, a considerable burden is induced by this obligation for every single enterprise. During the last […]