I've written quite a number of posts on this blog about the increasing need in the bio/pharma industry to have better characterization, control and traceability on raw materials being used in the process of producing drugs. The regulatory bodies around the world - FDA, EMEA, etc - clearly are placing more and more emphasis on this need. Quality is paramount in the production of safe and efficacious products. The very public incidents of quality lapses with major manufacturers only serves to heighten this concern - whether the incident stem from a China, US or EU based manufacturer.
Several previous posts highlighted SAFC's new raw material characterization program aimed at better characterizing and qualifying materials used in cell culture based manufacturing of biopharmaceuticals. You can review these here, here, here, here and here. (Told you, I've posted about this before). You can also refer to the popular Raw Material Detective series of posts for some real life examples.
Now, SAFC introduces its Enhanced Quality Program (EQPSM). The EQP is designed to transparently show customers the Quality levels associated with the large number of SAFC products that could be used in manufacturing. This is meant to aid customers in choosing the RIGHT product for their application - as quality needs are application specific in many instances. EQP levels differ in their degree of quality certification, documentation and change control. EQP products fulfill a range of needs from industrial applications through the more heightened controls of the biopharma and pharma industry. Premium, Elite and cGMP levels exist within EQP.
EQP is consistent with ISO requirements and meets international standards for multiple industries. One of the significant features of the EQP is the Change Control Notification (CCN) program. Customers may subscribe to this program at www.safcglobal.com/ccn. On our website, customers can also search on CAS numbers to determine if we have a product that meets your Quality needs. If not? Customers may request an upgraded product and our compliance specialists will be able to determine through consultation whether we can accomodate that change.
For more information, refer to the links in this post - and on overview can be found on this attached flyer.
Posted by Bruce Lehr July 24th 2010.