What is CMC in regulatory affairs 

CMC stands for Chemistry, Manufacturing and Controls

Lets discuss topic in brief. As it has three fundamentals, each one has its role.

Chemistry:

This section includes Drug product's characterisation like its starting material (API, Drug substance), Impurity profile, Stability studies. By that it helps in understanding chemical nature and its behaviour, Properties of drug substance and Drug product. There by, it in turn helps in manufacturing and controls.

Manufacturing:

It includes how the Drug substance or Drug product is Manufactured, How it went under Stages and Sources of Raw materials used. All those information is included here.

It says that Manufacturing part shares the complete process and Procedure of the Final product.

Starting Materials----------------------→ Intermediate stages----------------------→ Final product

By this, we could know how the trend of batches behave.

Controls:

Controls section include the Specification, Analytical testing, Process validation and confirming the meeting the acceptance. By this, the Safety and effective, Purity and Quality of the Drug substance and or Drug product is known.

CMC is submitted during the NDA, ANDA approvals and any other Regulatory approvals.

CMC is monitored throughout the life cycle management of the Drug substance and Drug Product ensuring its Safety and Efficacy to use.

It is CMC regulatory affairs department to ensure the submission and management of CMC.