- Develop and enhance laboratory controls
- Perform laboratory investigations
- Assess bioequivalence studies and evaluate adequacy of bioanalytical methods and laboratories
- Optimize product formulation and processes
- Assess product stability
- Evaluate process designs
- Develop or refine process control strategies
- Assess and improve process analytical technology (PAT)
- Evaluate the development of analytical methods
- Set specifications
Data integrity:
- Evaluating and enhancing systems to assure data integrity—covering collection, documentation, management, source data changes, and security
- Assessing data integrity, whether voluntary or required by the FDA.
