The Excipients finally have come inside the auditing ring.
The much awaited standards for auditing Excipients is going to release. The standards, known as Excipact some time in January 2012. IPEC, the excipients association says that this standard will give suppliers, users and auditors manufacturing and distribution standards that ensure product quality and minimize regulatory burden.
The safety of medicines for patients is paramount to all those involved in the supply chain. To assure the quality of medicines produced, risks in the supply chain need to be evaluated and minimized, and this includes not only active pharmaceutical ingredients (APIs) but also pharmaceutical Excipients.
At the same time, the major Excipients manufacturers are working hard to keep pace with the growing formulations, various delivery systems and technologies. Therefore, various important features are being considered in their Excipients product portfolio to influences Excipients role during formulations development. For example, BASF says role of solubility and bio availability will be key focus for its pharmaceutical excipient product development efforts for next few years.
Also the price rise among Excipients and cut throat competition compels their manufacturers to invent niche processes in shortest period of time, however maintaining the best quality for formulation development.
Going by the technologies and studies put into the Excipients development process, it was paramount that the regulatory agencies must have framed up GxP model for assessing quality for manufacturing these goods.
To download these standards, click here
The much awaited standards for auditing Excipients is going to release. The standards, known as Excipact some time in January 2012. IPEC, the excipients association says that this standard will give suppliers, users and auditors manufacturing and distribution standards that ensure product quality and minimize regulatory burden.
The safety of medicines for patients is paramount to all those involved in the supply chain. To assure the quality of medicines produced, risks in the supply chain need to be evaluated and minimized, and this includes not only active pharmaceutical ingredients (APIs) but also pharmaceutical Excipients.
At the same time, the major Excipients manufacturers are working hard to keep pace with the growing formulations, various delivery systems and technologies. Therefore, various important features are being considered in their Excipients product portfolio to influences Excipients role during formulations development. For example, BASF says role of solubility and bio availability will be key focus for its pharmaceutical excipient product development efforts for next few years.
Also the price rise among Excipients and cut throat competition compels their manufacturers to invent niche processes in shortest period of time, however maintaining the best quality for formulation development.
Going by the technologies and studies put into the Excipients development process, it was paramount that the regulatory agencies must have framed up GxP model for assessing quality for manufacturing these goods.
To download these standards, click here
