GMP NEWS 2019

The BfArM has awarded the first contracts for the cultivation of medicinal Cannabis in Germany to two manufacturers. This means that the cultivation of pharmaceutical quality Cannabis in Germany can now commence.

The Qualified Person (QP) often reviews the batch documentation personally prior to certification of a batch. But is the QP obliged to the review of the batch documentation?

The FDA has published a Warning Letter to a manufacturer of umbilical cord blood products for therapeutic use in humans due to deficiencies in the classification and manufacture of the products.

The Office of Pharmaceutical Quality (OPQ) was established in 2015 within the FDA as part of the Center for Drug Evaluation and Research (CDER). The aim was to ensure the quality of medicinal products throughout their entire lifecycle, from development to commercialisation. Now, the FDA's OPQ has reviewed the year 2018 and published a 13-page report.

In March, the American authority FDA issued a Warning Letter to a US pharmaceutical manufacturer due to numerous violations of GMP. Among other things, inadequate cleaning of the equipment, errors in the stability studies as well as in contamination control were found.

There is currently a growing interest in the development of therapies derived from cannabis and its components.The FDA recently announced to form an internal agency working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD.

In the current issue of the Pharmacopeial Forum, the USP general chapters on plastic packaging materials have been re-published for comment.

FDA's regulations regarding cleaning validation are now relatively old. A GUIDE TO INSPECTIONS VALIDATION OF CLEANING PROCESSES dates back to the early 90s. In this context, Warning Letters show the "current thinking" of the FDA.

The FDA provided additional guidance on risk-based monitoring for effective oversight, including Data Integrity. Read more on FDA`s draft Guidance for Industry A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers.