Development and Commercialization .......................................................... 342 8.2.1 Regulatory Environment .................................................................. 342

8.3 Validation of Analytical Procedures ............................................................ 345 8.3.1 Regulatory Requirement to Validate Analytical Procedures ...........346 8.3.2 Regulatory Guidelines on Method Validation .................................. 347

8.3.2.1 International Conference on Harmonization (ICH) ..........348 8.3.2.2 FDA Guidance Documents ................................................348 8.3.2.3 Other FDA Documents ......................................................348 8.3.2.4 Pharmacopeia .....................................................................348