GMP News - APIs and Excipients

Hop (Humulus lupulus) is commonly known for its use in brewing beer. However, it is also used as a herbal drug. The Ph. Eur. Monograph Hop Strobile has now been proposed for revision.

The HMPC issued a concept paper on the revision of the Guideline on declaration of herbal substances and herbal preparations in herbal medicinal products (HMPs).

In February 2023, the U.S. FDA issued a Warning Letter (WL) to the US American company "Dunagin Pharmaceuticals Inc. dba Massco Dental" after having inspected its site in Arkansas in August/September 2022.

The formerly named "CEP of the future" is now named "CEP 2.0", as recently reported on the website of the EDQM. The new design of the CEP shall support stakeholders in handling CEPs and shall increase the transparency of the provided information.

The U.S. Food and Drug Administration (FDA) has once again published a Warning Letter to a US manufacturer of hand sanitizers. During an inspection, several CGMP violations were found. In addition to inadequate release testing in general, the finished products are likely to be contaminated with methanol.

The U.S. Food and Drug Administration (FDA) sent a Warning Letter to a drug manufacturer in Istanbul. During an inspection, several CGMP violations were found. Among other things, this concerns identity testing of incoming components, process validation and stability testing.

The HMPC adopted a Question & Answer (Q&A) document regarding medicinal products. The document aims to clarify the basic regulatory requirements for stakeholders that may not have extensive experience with the EU pharmaceutical regulatory system. In addition, the EMA started a call for scientific data in order to establish an EU herbal monograph.