At the end of July, the FDA (CDER) published a draft guidance document for setting endotoxin limits during the development of drugs for oncology and biological products.
The US Food & Drug Administration (FDA) explicitly explains the deficiencies in the area of quality control in its Warning Letter for the company "Signa SA de CV".
In July 2020, the FDA updated and expanded its series of guidelines on the topic of cell and tissue products with a revised version of the Guideline Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use
In addition to the publication of a large number of guidelines and supporting documents in the field of cell and tissue products, the FDA also provides insights into the biological research projects of its scientists on its website.
The European Commission has published a communication to prepare for the end of the transition period. There are also indications for the pharmaceutical sector.
The VDI (Verein Deutscher Ingenieure, Association of German Engineers) has re-issued Part 2 of VDI Standard 6022 on the requirements for hygiene training of persons entrusted with HVAC systems. The latest valid version of this document dates from 1999.
A while ago, the FDA published an update on Biological Product Deviation with regard to products based on human tissues or cells.
This is now also possible for ASMFs and the procedure is clearly described in the updated Q&A document of the CMDh.
Inspectorates are restarting domestic on-site inspections. Announcements were made by FDA and MHRA.
The U.S. Food and Drug Administration (FDA) has issued a warning letter to Washington Homeopathic Products, Inc. due to specific violations of CGMP regulations. These violations include failure to establish an adequate quality control unit, failure to conduct at least one test to verify the identity of each component of a drug product, and failure to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods.