GMP News - Quality Assurance

Like the USP chapter "Balances <41>", the chapter "Weighing on an Analytical Balance <1251>" has been updated and revised. The new version of this chapter has now been posted on the USP Pharmacopeial Forum website for comment. Comments on this draft, which is based on the previous version from May 2018, can be submitted until 30 November 2023.

The FDA published the final guidance on standards for the interoperable exchange of track & trace information for certain human prescription drugs.

To minimize possible disruptions in the distribution of certain prescription drugs in the United States, the FDA does not intend to take action before 27 November 2024 against dispensers who do not verify the product identifiers of suspect or illegitimate products.

The required storage conditions for medicinal products must always be met. If deviations are discovered after the product has left the warehouse, a recall may be the consequence. This is shown by an example from the US, which is about possible pest control problems and temperatures in excess of the storage condition instructions on the product labeling.

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.

A recently issued USP stimuli article describes advances in product quality and performance tests for topical and transdermal delivery systems (TDS). In particular, the article focuses on physicochemical and structural characterization tests for semisolid drug products.

In August 2023, the U.S. FDA issued a Warning Letter to the US American company "Cosmobeauti Laboratories & Manufacturing Inc." after having inspected its site in March 2023. The significant violations of cGMP regulations for drug products, which are mentioned in the Warning Letter, can be checked here.