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.
From The Corner Lab - Blog Posts
Recent news articles and industry analysts have discussed what’s wrong with and how to fix pharmaceutical industry R&D. It's no secret the industry has suffered, and continues to do so, and that innovation appears to have stalled with new drug approvals having slowed considerably. Add to this that the stock prices of the large pharmaceutical companies are down and large numbers of jobs have been lost in the last ten years. ,/span>