The manufacturer shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier. To the extent required for traceability, the manufacturer shall maintain documents and records of relevant purchasing information. 7.4.3 Verification of purchased product: The manufacturer shall establish and implement the inspection or other activities necessary for ensuring ...

3. To enhance the communication aspects, CDSCO should ensure that the industry representatives, and other stakeholders have easy and open access to all the relevant regulatory information and are educated about the drug regulatory requirements, process involved in new drug development. 4. Similarly, CDSCO meetings including Pre-submission/ Post–submission/SEC meetings should be held as per the lai ...