In February 2024, the U.S. FDA issued a Warning Letter to the Chinese company "Sichuan Deebio Pharmaceutical Co. Ltd." after having inspected its site in September 2023. According to the Warning Letter the firm has a lack of microbiology laboratory Data Integrity.
Even animals with legs can keep the regulatory authorities busy. In December, a US manufacturer received a Warning Letter, the first section of which deals with deficiencies in the area of pest control.
The FDA defines advanced manufacturing as innovative pharmaceutical manufacturing technologies or an approach with the potential to improve the reliability and robustness of the manufacturing and supply chain. The FDA encourages the early adoption of such advanced manufacturing technologies and has established a programme for this purpose.
The final text for USP <383> Cured Silicone Elastomers for Pharmaceutical Packaging and Manufacturing Components has been published in the USP. The chapter will become official on 1 December 2027. Early adoption of the requirements in this chapter is permitted by USP.
When reading an FDA Warning Letter, you might have recognised that under GDUFA programme, the facility may be eligible for a so-called Post-Warning Letter Meeting. But what is this?
The U.S. Food and Drug Administration (FDA) has issued another Warning Letter to a Chinese manufacturer regarding significant violations of cGMP regulations for finished pharmaceuticals, based on a review of records.
The House Energy and Commerce Subcommittee on Oversight and Investigations held a hearing, which focused on the comparative frequency and quality of FDA inspections for foreign versus domestic drug manufacturers. Read more in our GMP News.
As part of the measurements against supply shortages in the pharmaceutical sector, the first version of the "Union list of critical medicines" and further information on this was published on the EMA website at the end of last year. This list contains more than 200 active substances that are considered critical in the event of a supply shortage and whose shortage must be avoided at all costs.
Swissmedic's nitrosamine Q&A document "Update of the requirements for dealing with nitrosamine impurities in medicinal products" was updated in January 2024 and is now available in the new version on the Swissmedic website.
The EMA has received a grant of ten million euros from the European Commission to support regulatory systems in Africa, and in particular for the setting up of the African Medicines Agency (AMA).