Importance and globalization status of good manufacturing practice (GMP) requirements for pharmaceutical excipients

Saudi Pharm J. 2015 Jan;23(1):9-13. doi: 10.1016/j.jsps.2013.06.003. Epub 2013 Jun 26.

Abstract

Pharmaceutical excipients are no longer inert materials but it is effective and able to improve the characteristics of the products' quality, stability, functionality, safety, solubility and acceptance of patients. It can interact with the active ingredients and alter the medicament characteristics. The globalization of medicines' supply enhances the importance of globalized good manufacturing practice (GMP) requirements for pharmaceutical excipients. This review was intended to assess the globalization status of good manufacturing practice (GMP) requirements for pharmaceutical excipients. The review outcomes demonstrate that there is a lack of accurately defined methods to evaluate and measure excipients' safety. Furthermore good manufacturing practice requirements for excipients are not effectively globalized.

Keywords: Excipient’s Safety; Excipient’s evaluation; Globalization; Good manufacturing practice; Importance of pharmaceutical excipients.

Publication types

  • Review