International Inspections: TGA and the Management of GMP Compliance Signals
The Australian Therapeutic Goods Administration (TGA) has published a guidance on the management of so-called GMP compliance signals for domestic and foreign manufacturers of medicinal products and biological products.
FDA updates Q&A Guidance on Inspections and Applications
After the publication of the Guidance for "Remote Interactive Evaluations", FDA has updated its "Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers Guidance for Industry" with some further clarifications.
The UK MHRA has established a new GMDP database with information issued by the MHRA and from EudraGMDP relating to manufacturing, wholesale authorisations and certificates and non-compliance statements.
ATMP - Critical Deficiencies during an Inspection in the Netherlands
An inspection by the Dutch authority in February revealed a number of deficiencies at a manufacturer of advanced therapy medicinal products (ATMPs). The Non Compliance Report that was published shows which of these were critical.
Covid-19 Vaccine Mix-Up in the US - what's behind it?
It has been recently reported in the press that there was a mix-up in the manufacturing of the J&J Covid-19 vaccine at a contract manufacturer. Already one year before, considerable quality deficiencies were found at the site. Now the site had to stop producing for now.
GDP-Non-Compliance-Report for German Wholesale Distributor
The Competent Authority of Germany (Bezirksregierung Düsseldorf) has entered a new GPD Non-Compliance Report dated into the EudraGMDP database due to serious GDP violations at a German wholesaler. The case involves trading of falsified medicinal products and storage of expired medicinal products in regular stock. Furthermore, there are doubts on the reliability of the Reponsible Person and the CEO due to an ongoing criminal procedure.
FDA Warning Letter to Mexican Manufacturer based on Review of Documents
The U.S. Food and Drug Administration (FDA) recently published a Warning Letter to a Mexican firm whose facility is registered as a manufacturer of over-the-counter (OTC) drug products in the United States. The Warning Letter is not based on inspection findings from an onsite audit but on the review of documents that the company was required to send at the request of the FDA. The FDA found different serious deficiencies based on the submitted documents.
Poor Documentation Practice caused U.S. FDA Warning Letter
In March 2021, the U.S. FDA issued a Warning Letter to a Chinese manufacturer of over-the-counter (OTC) drug products called "Foshan Biours Biosciences Co., Ltd." due to significant violations of cGMP regulations for finished pharmaceuticals.