Sponsored by:
Reduce Your Risk of GMP Audit Citations
The US Food and Drug Administration (FDA) is responsible for ensuring the quality of medicines that are supplied to the American market.
Who audits medicine manufacturers?
The US Food and Drug Administration (FDA) is responsible for ensuring the quality of medicines that are supplied to the American market. They undertake inspection audits of drug manufacturing facilities worldwide to ensure that the drugs are being manufactured according to the current Good Manufacturing Practice (cGMP) standards. Most other countries have equivalent regulatory bodies and over 50 of them (including the FDA) are part of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). This scheme aims to develop, implement, and maintain harmonized GMP standards and inspection systems.
What happens during an audit?
A regulatory auditor will visit a drug manufacturing site to assess whether products are being manufactured according to the latest GMP standards. Sometimes, an auditor will specifically inspect the Quality Control (QC) laboratory on the site. The FDA publishes guidelines for auditors to use when inspecting a QC lab.
If an FDA auditor observes a problem during an audit, they list the problem on an FDA Form 483. A summary of the findings on these forms is published each year by the FDA.
