Where should justification for reprocessing be included?
If justification for reprocessing is warranted by a regional authority, the information would be included as part of the description of the manufacturing process in 3.2.S.2.2. If there are critical controls associated with the reprocessing operation, the critical controls should be included in 3.2.S.2.4. If validation information is warranted, the validation information should be included in 3.2.S.2.5. S.2.6 Manufacturing Process Development Q: Should bioavailability/bioequivalence study results that demonstrate product comparability following process changes be described in 3.2.S.2.6? A: Reports of Bioavailability/Bioequivalence studies that demonstrate comparability/equivalence after formulation or process changes should be presented in Module 5. Cross-references to these reports should be placed in section 3.2.S.2.6 (for drug substance process changes), 3.2.P.2.2.1 (for drug product formulation changes) or 3.2.P.2.3 (for drug product process changes). A brief summary of the reports
