INDUSTRY AND CDSCO COMMUNICATION 1. CDSCO needs to work collaboratively and cooperatively with Industry, academia and others to promote new drug development and to expedite the review process and making the safe and effective new drugs available at the earliest to address various disease burden in the country. 2. CDSCO should be dedicated to ensure that all persons involved in the new drug develop ...

Design and development validation: Design and development validation shall be performed in accordance with planned arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use. Design validation shall be performed under defined operating conditions on initial production units, lots, or batches or their equivalence. Design v ...

The manufacturer shall establish arrangements for these processes including, as applicable:— (a) defined criteria for review and approval of the processes; (b) approval of equipment and qualification of personnel; (c) use of specific methods and procedures; (d) requirements for records; and (e) revalidation. The manufacturer shall establish documented procedures for the validation of the applicati ...