Preventive action: The manufacturer shall determine action to eliminate the causes of potential non-conformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems. A documented procedure shall be established to define requirements for-— (a) determining potential non-conformities and their causes, (b) evaluating the need for a ...

3. As per the rules, for manufacture or import of new drugs, the manufacturers/ importer are required to obtain manufacturing/ import permission from CDSCO under the New Drugs and Clinical Trials Rules, 2019 before Licencing the product under the Drugs Rules, 1945. 4. Robust system for evaluation of applications of clinical trial and new drug which contains data of Chemistry, Manufacture, Control ...