2. RATIONALE FOR THE REPORTING AND CONTROL OF DEGRADATION PRODUCTS

The applicant should summarise the degradation products observed during manufacture and/or stability studies of the new drug product .This summary should be based on sound scientific appraisal of potential degradation pathways in the new drug product and impurities arising from the interaction with excipients and/or the immediate container closure system .Or the use of excipients that are crude products of animal or plant origin ) can be considered as part of the justification for selection of alternative thresholds based upon manufacturing experience with the proposed commercia process .