Wednesday, September 30, 2015
API outsourcing is increasingly predictable. Many companies provide
a range of services and technology types for pharmaceutical clients
who may need to outsource one API1, or they may need to outsource
many APIs over a long period2. Herein I ...
Wednesday, September 25, 2013
Many years ago I heard a QA executive say, “The only difference between
two batches of a validated process should be their dates of manufacture.”
The underlying message here is that the manufacturing process should
be so well designed, so well ...
Tuesday, January 29, 2013
An active pharmaceutical ingredient (API) sourcing strategy is built upon a well-defined manufacturing process. The keys to the strategy involve using long-term suppliers early in the development process so that the control strategy for their ...