GMP News

Overview of the Incoterms Rules

The Incoterms rules are frequently used in international and domestic contracts. In this article, you will get an overview of the Incoterms 2020 and their meaning.


MHRA Releases New Version of the Green Guide

The 2022 edition of the Rules and Guidance for Pharmaceutical Distributors (the "Green Guide"), compiled by the Medicines and Healthcare products Regulatory Agency (MHRA), was published. It provides an authoritative source of European good distribution practices and UK guidance, information and UK legislation on these activities.


MHRA Releases Recording of the Medicines Supply to Northern Ireland Webinar

On either 02 or 03 February 2022, interested parties could take part in a live webinar of the Medicines and Healthcare products Regulatory Agency (MHRA) on Medicines Supply to Northern Ireland. A recording of the webinar, excluding the Q&A sessions, was now published.


FDA Guidance for Chimeric Antigen Receptor (CAR) T Cell Products

With a draft guidance for the development, manufacture and control of chimeric antigen receptor (CAR) T cell products, the FDA is expanding its recommendations for advanced biological products and providing further guidance to developers and manufacturers.


FDA revises Recommendations on Investigational COVID-19 Covalescent Plasma

The FDA has already updated its recommendations on handling plasma donations from COVID-19 diseased donors several times. Recently, a new update of the Guidance for Industry Investigational COVID-19 Convalescent Plasma was published.


Genome Editing in Gene Therapy - FDA Draft Guidance for IND

Gene therapies are becoming increasingly important. One method is the so-called genome editing. The FDA has published a draft guidance for Investigational New Drugs (IND) for these Gene therapy products.


FDA updates Information on Bacterial Contamination of Platelets for Transfusion

In December, the FDA updated its important information for blood establishments and transfusion services on bacterial contamination of platelets for transfusion, which has been published since 2016.


Japanese Pharmacopoeia 18th Edition - English Version Now Available

The English translation of the Japanese Pharmacopoeia (JP) 18th edition is available for download free of charge.


FDA moves on with Quality Metrics Reporting Program

The US Food and Drug Administration (FDA) is trying to revive its somewhat forgotten Quality Metrics Reporting Program. Now the FDA is asking for specific feedback.


Still Issues with CBD Products

The FDA issued again Warning Letters to several companies for selling Cannabidiol (CBD) products with misleading product claims.


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