USP: Chapter "Weighing on an Analytical Balance <1251>" published for Comments
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.
Changes in Testing for Nitrate and Endotoxins in pharmaceutical Waters in the European Pharmacopoeia
In the Ph.Eur. Supplement 11.4, the EDQM announces the deletion of the test for nitrate in Water For injection (WFI) and Purified Water if the test for conductivity meets the pharmacopoeial requirement for WFI. In addition, the use of recombinant factor C (rFC) to test for bacterial endotoxins will be allowed. Find out more about the changes in the Ph.Eur. Monographs Water for Injection (0169) and Purified Water (0008).
WHO Draft Working Document on Good Practices for Quality Control Laboratories published for Comments
The World Health Organization (WHO) has published a draft working document on "WHO good practices for pharmaceutical quality control laboratories (QAS/21.882)". The deadline for submitting comments is 06 October 2023.
Revised USP Chapter <31> and New Chapter <1331> on Volumetric Apparatus Published for Comments
In the Pharmacopeial Forum, PF 49(5), two USP chapters related to volumetric apparatus were published for comments. It is proposed to make several changes in Chapter <31> Volumetric Apparatus. Furthermore, a new general chapter <1331> Use and Calibration of Volumetric Apparatus has been developed.
USP: Comments possible on the Topic "Balances <41>"
The latest valid version of the USP chapter "Balances <41>" has been substantially revised and is now posted for comment on the USP Pharmacopeial Forum website. This revision follows updates to the USP chapter "Weighing on an Analytical Balance <1251>" and the general chapter "Balances" of the European Pharmacopoeia (Ph. Eur.). Comments on this draft can be submitted until 30 November 2023.
Ethylene and Diethylene Glycol Testing again in Focus of FDA Warning Letters
In recent months, the awareness for the impurities diethylene glycol (DEG) and ethylene glycol (EG) in pharmaceutical products was increased due to several FDA Warning Letters. We have reported on different examples where manufacturers failed to conduct proper identity testing of glycerin and other high-risk components. Now two more Warning Letters have been published, which also deal with this issue.
New Proposals for Revision of USP Chapters <761> and <1761> on NMR Spectroscopy Published for Comments
In the Pharmacopeial Forum, PF 49(5), revisions of USP chapters <761> Nuclear Magnetic Resonance Spectroscopy and <1761> Applications of Nuclear Magnetic Resonance Spectroscopy are being proposed. Based on the comments received, the previous proposals published in PF 48(4) have been canceled.
Draft of Harmonized USP Chapter <701> Disintegration Published for Comments
In the Pharmacopeial Forum, PF 49(5), a proposal of a revised USP General Chapter <701> Disintegration has been published for comments. The chapter was updated as part of the process of international harmonization of the European, Japanese, and United States pharmacopeias. The comments period runs from 01 September to 30 November 2023.
Critical Quality Attributes for Topical Dosage Forms
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.
Publication of EMA Document on the Establishment of a Guideline on mRNA Vaccines
More and more authorities are trying to create regulations for the production of new technologies by publishing guidelines. In this case, the European Medicines Agency (EMA) is asking for assistance in developing a guideline on the manufacturing of mRNA vaccines.
U.S. Warning Letter caused by Data Integrity Failures
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.
WHO Draft Working Document on Biowaiver Project published for Comments
The World Health Organization (WHO) has published a draft working document entitled WHO Biowaiver Project - Prioritization exercise of active pharmaceutical ingredients for cycle VI (2024) and preliminary results from cycle V (2023). The deadline for submitting comments is 10 September 2023.
Denmark clarifies Status of the Ph. Eur. Cannabis Monograph
The Danish Medicines Agency clarified that the Danish monograph for Cannabis Flower will become invalid and removed from the Executive Order on Danish Drug Standards once the Ph. Eur. Cannabis monograph becomes official.
The USP adopted the new general chapter <1567> Pyrrolizidine Alkaloids as Contaminants. Twenty-eight PAs are selected to be monitored and manufacturers of herbal medicinal products should use a risk-based approach for determining appropriate limits and testing requirements.
Proposed Product Quality Tests for Food Supplements
The USP proposed a new General Chapter <2800> Multi-Ingredient Dietary Supplement Products - Product Quality Tests in the Pharmacopeial Forum. The chapter is intended as an informational chapter, not as a requirement for compliance.