Wednesday, February 01, 2017
Determining practical sources of raw materials and regulatory starting materials (RSMs) that are not produced under good manufacturing practices (GMP) is often far from a trivial pursuit.
Throughout the developmtent lifecycle of a drug, API manufacturing
processes increase in scale and control, as does the level of required
process knowledge. Technology transfer packages that reflect the state
of knowledge and capability of a given...
Monday, February 23, 2015
The impetus for this article was provided by a panel discussion held at PharmaChemOutsourcing in September 2014, during which a major focus of the discussion was how much effort to invest in developing and understanding the chemical processes used to...
Monday, February 03, 2014
The successful establishment of an emerging pharmaceutical company’s clinical drug supply depends on the outcome of work
performed by vendors to which the work is outsourced.