From The Corner Lab - Blog Posts

Why Test Raw Materials When The Supplier Provides A COA

Posted by Mary Oppel on Wed, Jun 06, 2012 @ 11:47 PM

Many raw material suppliers do only a fraction of their business with pharmaceutical, personal care products or cosmetics companies.  A raw material thus may have multiple uses. Consequently  specifications  may be  set to  ensure consistency of the material from lot to lot. However, the specification boundaries set by  a particular supplier, although consistent, can be  much wider than those acceptable for GMP manufacturing purposes. In addition, raw material suppliers may use their own internal analytical methods, rather than a compendial method, in support of a COA.

While having a COA from a supplier stating that a raw material  meets  compendial specification-such as USP- is important, the responsibility for qualifying that material falls squarely on the end user. 

Dr. J.V. Menoutis, a senior Laboratory Director at Quantex Laboratories explains that for different reasons  a raw material may not meet compendial specification, even if a supplier Certificate Of Analysis (COA) states so.

“There are instances”, notes Dr. Menoutis, “where the COA   states compliance of a raw material with a compendia, such as USP. However,  an  unknown  impurity shows up in a formulated products using that raw material. Subsequent testing to find out the source of the impurity then leads back to the raw material.  Having a process in place to routinely confirm that a  raw  material is as listed on its COA  avoids such problems and the potential for a product recall.  And sending raw materials for testing by a third party cGMP compliant contract lab, like Quantex,   provides  a good mechanism for  managing such risk and avoiding any adverse impact on branding ”

Topics: C of A, Test Raw Materials, Raw Materials testing, Supplier C of A