What is "A Risk-Based Approach.” as per GMP?

Question

USFDA adopting a new approach called A Risk-Based Approach.what is this ?and what is the preceding approach followed ?

Answer 1

CMC is the preceding approach (Chemistry, Manufacturing and Controls)

I'll give you a link to a site that explains it in more detail:

http://www.fda.gov/cder/gmp/gmp2004/risk...

"This new system should reduce the need to submit manufacturing supplements and increase first-cycle approval of new drug applications, thereby making drug products available to patients in a timelier manner. The system should also encourage manufacturers to implement new technologies, such as process analytical technology, and facilitate continuous manufacturing improvements."