Question

Regarding biotechnology/biomanufacturing/cGMPs, what tools does the FDA utilize to assure compliance?

Answer 1

Drug manufactures should meet quality standards so that each dose of the drug is of contamination free and of appropriate strength. There are a number of tools used by FDA to ensure drug manufacturers meet quality standards.

First such tool is to audit the production line. This is done to ensure that the drug meets the quality standards. Prior to drug approval, there is evaluation of manufacturing facilities.

The products in the market are tested in the FDA laboratories to confirm whether they meet drug standards.

The surveillance programs of FDA helps to identify problems so that manufacturers can address them before potential harm is caused to the patients.

Regular inspection of the drug manufacturing facilities is performed, with particular focus on facilities and drugs that have the potential to be most problematic.

Inspections are performed to evaluate complaints and allegations against a manufacturer.