cGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA.
cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.
Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately
control manufacturing operations.
The regulations in the GMP area, and thus also the framework conditions for your company, are constantly changing.
Sooner or later if you are a pharmaceutical manufacturer and want to distribute your products in the US, you will be inspected by FDA.
We will go over each item to be covered in each system and provide examples of what compliance with the regulations looks like and cover some failures too.
This course is designed to help you be prepared for that
inspection by letting you know what FDA is looking for in each
of the 6 systems that they cover. Compliance Program
7356.002 is the instruction used by FDA investigators to plan
their inspections as well as to know what FDA expects them to
report on. We will explore this instruction and take the mystery
out of the specific objectives.