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 have become increasingly available globally as trading goods. This has often resulted in the non-compliance of APIs with the predefined and specified quality standards, affecting the safety and the health of patients who consume products that contain such ingredients. Continue reading →Auditing / Qualification of Active Pharmaceutical Ingredient Manufacturers by Accredited Inspection Bodies 18. March 2009
Auditing / Qualification of Active Pharmaceutical Ingredient Manufacturers by Accredited Inspection Bodies
in: Pharm. Ind. 70, No. 12, 1459-1463 (2008)
Dr. Wolfgang Heisig, blue inspection body GmbH, Muenster, and Dr. Uwe Amschler, Schwentinental
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 months the responsible competent authorities have intensified their focus in the direction of the controls actually being carried out. Continue reading →