Drug Substance Synthesis and GMP
GMP in R & D: Part 1 - Drug Substance Synthesis
A general overview of the principles of GMP during the development stage of an active pharmaceutical ingredient (API), from the standpoint of a scientist, chemist, microbiologist, biochemist, or a technician and particularly anyone new to the pharmaceutical industry who may not be aware of the basic principles of GMP.
It asks the question ‘Where does GMP begin in R & D?’ and explains the comparisons between GMPs which apply to R & D and those which apply to the manufacture of medicinal products for sale.
The principal topics focus on Documentation, Contamination Control, Process Controls, Validation and Qualification.