GMP News

One of the most important documents in the context of medical device regulation is the technical documentation. Updated as version 2, a helpful position paper from the Team Notified Body provides assistance in this regard as a best practice guide.

An EU Regulation laying down specific rules for medicinal products for human use for Northern Ireland has been published in the Official Journal of the EU. It mainly concerns importation into NI and safety features.

The European Medicines Agency (EMA) has published on its website the detailed minutes of the Herbal Medicinal Products Committee (HMPC) meeting from 13-15 March 2023. In the meeting, the HMPC discussed some issues known to cause difficulties in procedures and ideally to be addressed during the current GACP revision.

The EDQM has published a new edition of the Guide for the elaboration of monographs on herbal drugs and herbal drug preparations. The Guide provides general guidance on the structure of Ph. Eur. monographs of herbal drugs and herbal drug preparations and on the information to be included in them. In addition, principles for the preparation and revision of herbal monographs are explained.

During GDP events organised by the ECA, the wish came up to compile a list of relevant abbreviations used in the GDP environment. We have prepared such an overview.

More than 60 participants attended the ECA Webinar "GDP Update 2023" in March. Many interesting aspects were discussed in the Q&A session. In total, about 20 questions were addressed to the speaker, Dr. Christian Grote-Westrick, which he answered in writing afterwards. We have compiled a selection of the questions and answers for you. You can read Part 3 here.

The Korean Ministry of Food and Drug Safety (MFDS) has revised the "Guidelines for Comparative Dissolution Test". A new version dated 18 May 2023 was published.

The FDA is requesting feedback on factors the agency should consider when reviewing proposed modifications to a risk evaluation and mitigation strategy (REMS) that are prompted by or related to changes in third-party vendors, also known as REMS administrators.

The FDA has issued a Warning Letter to a manufacturer in the USA who has not adequately tested its drug products. And the manufacturer relied on others for supplier qualification.

In a Warning Letter, the FDA describes the inadequate cleaning of product-contact surfaces and the associated risk of cross-contamination at an Egyptian pharmaceutical manufacturer.

The Mutual Recognition Agreement (MRA) between the EU and the US will be extended to veterinary medicines. This was announced by the EU Commission in a press release.

In a recent Warning Letter, the FDA criticises, among other things, an inadequate training system. How to respond to such an inspection deficiency?