ABSTRACT
The complexities involved in the new drug development (NDD) process have increased dramatically in the past 5 years. This has occurred mainly as the result of enhanced drug development techniques, significant regulatory initiatives (for example, the FDA’s 21CFR§11, “Electronic Records, Electronic Signatures”), and efforts for global registration of products. Spurred also by the effort to maximize profits, this phenomenon has placed the quality process under increased and manifold stress. The quality assurance (QA) and quality control (QC) processes are placed in the forefront by any major drug development organization. The efforts of QA will be reviewed in this chapter.
