Is an Identity Test needed for the content of all Containers?

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

Chapter 5 of the EU-GMP Guidelines requires "appropriate procedures or measures to assure the identity of the contents of each container of starting material". Annex 8 to the EU-GMP Guidelines permits "to sample only a proportion of the containers where a validated procedure has been established to ensure that no single container of starting material has been incorrectly labelled." Nevertheless identity tests of starting materials are required.

And the FDA is also investigating the implementation of such procedures during their inspections. In a recent Warning Letter, the authority criticises a Chinese company for their inappropriate identity testing: "Your firm failed to conduct at least one test to verify the identity of each component of a drug product."  The FDA not only cited the incomplete testing of incoming raw materials for their identity, strength, and other quality attributes. The firm also relied on the suppliers' certificate of analysis (COA) "without establishing the reliability of the suppliers' analyses through appropriate validation".

In addition, the company had no SOPs for quality unit operations like batch release, change control, complaint handling, supplier qualification or annual product reviews.