PHARMA REGULATORY CONSULTANTS IN DELHI

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 ...

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 ...

15.However, detailed guidance documents should be prepared providing the requirements and adequacy of global clinical data that can be considered for approval of any new drug in the country in both the cases where India was one of the participating countries in the global clinical trial or in cases where India was not a participating country. 16.The sponsor intending to submit NDA to CDSCO for mar ...

General The manufacturer shall establish documented procedures for traceability. Such procedures shall define the extent of product traceability and the records required. Where traceability is a requirement, the manufacturer shall control and record the unique identification of the product. Note: Configuration management is a means by which identification and traceability can be maintained.