What is cGMP compliance? Why is cGMP compliance so important?

[Shalini]

cGMP compliance assures consumers that the drugs are manufactured following the stipulated quality practices. As cGMP emphasizes quality control, the facilities are built as per a regulated design and manufacturing process. The FDA emphasizes the need for cGMP compliance to ensure the drugs that reach the market are safe for consumption. Notably, the recent cGMP regulations were published in 2016. cGMP compliance implies that

Facilities are in good condition
Types of equipment are properly maintained and calibrated
Employees are qualified and fully trained
Processes are reliable and reproducible

cGMP is flexible as it allows an individual manufacturer to decide how to best implement the necessary controls by using processing methods, sound design, and testing procedures. There are various cGMP regulations

– 21 CFR Part 210 that is applicable in manufacturing processing and packing, or holding of drugs

– 21 CFR Part 211 for finished pharmaceutical

– 21 CFR Part 212 for positron emission tomography drugs