Annexure II

Brief Description – Worst Case Evaluation:

This Annexure II provides a structured template for collecting information required for worst-case product evaluation in cleaning validation. It is designed to document the key characteristics of the drug product and its Active Pharmaceutical Ingredient (API) before deciding the cleaning validation worst case. The template includes space for recording the name of the API and relevant toxicological evaluation. It also captures important physical and product-related properties such as physical appearance, solubility, cleanability, and lowest therapeutic dose, which are essential factors for comparing products during worst-case selection. The form also identifies whether the information was obtained from Formulation and Development, Technology Transfer, or other sources, ensuring traceability of the supporting data. Signature fields for the responsible personnel, including name, designation, sign, date, prepared by, and checked by, help ensure proper review and approval of the assessment.