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 manufacture active
pharmaceutical ingredient (...
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 API manufacturing process
serve to set the ...
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.