Guidelines- 1. PDA Technical report No.: 29 (Revised- 2012)- Points to be considered for Cleaning Validation. Cleaning Validation Study necessary to validate cleaning process to be used before start of batch execution, and it gives- Assurance that the established cleaning process is effective and it prevents the carryover of previous product/ cleaning agents in subsequent batch. It Limits potential carryover to an acceptable level. Controls potential carryover of the products, intermediate, and impurity. Quality of the next product does not compromised with the waste of previous product. TRF (Total Risk Factor) - Decides the selection of worst case molecule (Marker compound) for validation of cleaning process. TRF components are Toxicity (OEB), Solubility, Potency (Minimum therapeutic dose), and other factors as cytotoxicity. OEB and Solubility are the major component and shall be added as multiplier of 6. Potency and other factors (if any) shall ...