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 ”