GMP News - Analytical Quality Control

To help address concerns about the supply of glass vials, the USP intends to revise the packaging and storage statements in several USP monographs for parenteral products which currently prescribe a specific type of glass.

The Chemical Analysis Expert Committee intends to revise the USP General Chapter <621> Chromatography. Changes to the subsection on the signal-to-noise ratio are planned.

The USP chapter "<1467> RESIDUAL SOLVENTS-VERIFICATION OF COMPENDIAL PROCEDURES AND VALIDATION OF ALTERNATIVE PROCEDURES" refers to the information provided in chapter <467 RESIDUAL SOLVENTS> and has thus now also been updated. The new draft has already been published on the website of the Pharmacopeial Forum of the USP and can be commented on until 31 March 2023.

The U.S. Food and Drug Administration (FDA) has published a so-called untitled letter to a US company. The FDA states that the firm violated the Drug Supply Chain Security Act (DSCSA). Specifically, the letter concerns a former subsidiary of the company that was a licensed pharmacy and wholesale drug distributor.

In the Pharmacopeial Forum, PF 49(1), a proposal for a revised USP General Chapter <1236> Solubility Measurements was published. Based on comments received, some revisions were made in addition to those proposed in PF 48(2).

The Q&A document "Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products", which was jointly prepared by the EMA and the CMDh, has been updated and the latest version published on the EMA website.

As already reported a few months ago, a revised general chapter 2.2.46. Chromatographic separation techniques has been published in Ph. Eur. 11.0. The implementation date is 01 January 2023. One of the changes is the sensitivity requirement. In this context, the EDQM has now published a press release, stating that this change might be technically challenging for a number of users. Therefore, there will be another revision.