GMP News

The quality of pure steam is determined by its condensate. This has the same quality characteristics as WFI (Water For Injection). The purity of the steam is usually very high due to the phase transition from liquid to gaseous. Nevertheless, in individual cases there may be increased measured values in the test point conductivity and/or TOC. Read about the possible causes.

The Spanish Agency Of Medicines And Medical Devices has added a new GDP Non-Compliance Report to the EudraGMDP database. During an inspection of a wholesale distributor, a series of deviations from Good Distribution Practice were found. This led to a suspension of the company's authorisation for procuring, holding, supplying and storage by contract of human medicinal products.

For fiscal year 2022, the FDA's dashboard lists 168 inspections at pharmaceutical companies in the EU. What is the reason for this?

The U.S. Food and Drug Administration (FDA) has issued three somewhat similar Warning Letters. The companies concerned had each failed to respond to requests for records and other information.

One discussion we have again and again at seminars is the question of planned changes. But such terminology can lead to problems.

The USP Herbal Medicines Compendium (HMC) published a revised version of the previously proposed Cannabis Species Inflorescence monograph. In particular, the Content of Terpenes section has been removed from Specific Tests because there is insufficient information to support the use of terpenes for medical purposes.

As previously announced the new Ph. Eur. monograph Cannabis flower was adopted and will be published in Ph. Eur. Supplement 11.5 in January 2024. Now, the Ph. Eur. decided to make the monograph immediately available on the EDQM website for information.

The German BfArM (Federal Institute for Drugs and Medical Devices) and the German PEI (Paul Ehrlich Institute) published version 8.2 of the guideline on the designation of medicinal products at the end of July, which can be viewed on both websites of the institutes. The above-mentioned guideline was fundamentally revised in 2023 and applies exclusively to medicinal products for human use. It is intended to support marketing authorisation holders and applicants in the selection of the designation of the respective medicinal products.

Biological medicinal products are gaining more and more interest. Due to the ever increasing complexity and diversity within these medicinal products, more questions arise. The EMA has now published a Q&A document to support the marketing authorisation holders presenting the information in the dossier correctly.

In the beginning of September, the stimuli document "Proposed Definitions of Excipient Components- Revisions to 2018 Definitions- PF 49(5)" was published for comment on the website of the Pharmacopeial Forum of the USP. Comments on this draft can be submitted until 30 November 2023.

Once again, the "Frequently asked questions about parallel distribution" have been revised and published on the EMA website. The information provided by the EMA on parallel distribution of centrally authorised medicinal products is set out in the Q&A in six paragraphs.

An expert group of the US Pharmacopoeia (USP) is working on a new chapter on wetting properties of pharmaceutical systems, which may have relevance for both batch and continuous manufacturing. The draft can be found in Pharmaceutical Forum PF49(5).