GMP News - Inspections/Audits

The FDA Warning Letters are a very good source to get to know how the FDA reacts to GMP deficiencies. In a current Warning Letter, the FDA comments on deficiencies in the context of process validation, among other things. What "CAPA" measures did it call for?

In the last few days and weeks, the U.S. Food and Drug Administration (FDA) has published several guidance documents related to the requirements under the Drug Supply Chain Security Act (DSCSA). Under the DSCSA, trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) are subject to certain requirements for enhanced drug distribution security.

The FDA uncovered serious deficiencies in the aseptic area during an inspection of a US manufacturer. Deficiencies in smoke studies, media fills, pressure monitoring and cleaning validation are listed.

PIC/S is a collaboration of regulatory agencies in the field of GMP for human and veterinary medicines. The goal of PIC/S is to provide harmonized standards and training to ensure that one inspection per site will also be recognized by every other authority. The 2022 report provides an overview of PIC/S activities for that year. What does it include?

When conducting GDP audits, it can be helpful to work with question lists. We have compiled typical questions for road transport operations.

At the beginning of August, the U.S. Food and Drug Administration (FDA) has published a new Warning Letter. As in several cases in recent months, it is again about a US manufacturer who failed to conduct proper identity testing of glycerin and other high-risk components. In addition, a number of other CGMP violations are documented.

Republican Congress members are worried that the US is overly reliant on sourcing from foreign manufacturers with a demonstrated pattern of repeatedly violating FDA regulations and express this in a letter to the FDA Commissioner.