The USP has published a General Chapter Prospectus for a new USP General Chapter <318> NMR Spectroscopy Monomer Ratio Determination for Lactide-Glycolide Polymers. The USP is requesting early input from stakeholders on this proposal, with an input deadline of 24 November 2024.
An incorrect classification of a biological product led to a Warning Letter from the FDA, even though there was no CGMP violation.
The FDA inspected a production facility of a US medical gas manufacturer in Pennsylvania (USA) in March 2024 and identified significant GMP violations.
In an unusually extensive Warning Letter to a Canadian manufacturer, the FDA lists a large number of deficiencies and violations, ranging from a lack of analysis of raw materials and the end product to illegal statements in the product description.
The FDA inspection uncovered serious violations at a US HCT/Ps manufacturer, including the unauthorised processing of bone tissue, the risk of sepsis and the lack of regulatory approval for the products, and issued a Warning Letter.
The FDA's inspection of a manufacturer of blood products uncovered significant violations of Current Good Manufacturing Practices (CGMP) for blood and blood components, leading to concerns about the safety, purity, and quality of their products. These violations included inadequate staff training, failure to follow procedures, poor record-keeping, and lack of proper investigation into discrepancies.
A new WHO guideline on the control of environmental pollution in the production of antibiotics has been published. The aim is to minimise the spread of antibiotic resistance through scientifically sound recommendations. The focus is on wastewater treatment and the proper disposal of solid waste from antibiotic production.
The European Commission has signed a first investment agreement to support biopharmaceutical research and development as part of the HERA Invest initiative. With funding of 20 million, it is supporting the French company Fabentech in the development of therapeutic antibodies against biological health threats.
USP <1047> Gene Therapy Products - Proposed revision was published in PF 50 (4) by the USP together with a whole series of further updates and revisions.
The FDA is announcing a program to enhance FDA's understanding of pharmaceutical manufacturing processes, innovations, and industry challenges. The program relies on pharmaceutical manufacturers, who host FDA staff at their facilities.