Manufacture of Medicines for Clinical Trials

GMP in R & D: Part 2 - GMP and the Manufacture of Medicines for Clinical Trials

A run-down of the GMP principles which apply to the production of investigational medicinal products and the distinction between producing batch-after-batch of product on a commercial scale by well-defined processes and the manufacture of development products for clinical trials.

Reference is made to Regulatory Guidelines; the significance of Documentation in R & D; Labelling; Process Controls; Contamination Control; Cleaning and Cleaning Validation.